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1.  Baby Business: a randomised controlled trial of a universal parenting program that aims to prevent early infant sleep and cry problems and associated parental depression 
BMC Pediatrics  2012;12:13.
Background
Infant crying and sleep problems (e.g. frequent night waking, difficulties settling to sleep) each affect up to 30% of infants and often co-exist. They are costly to manage and associated with adverse outcomes including postnatal depression symptoms, early weaning from breast milk, and later child behaviour problems. Preventing such problems could improve these adverse outcomes and reduce costs to families and the health care system. Anticipatory guidance-i.e. providing parents with information about normal infant sleep and cry patterns, ways to encourage self-settling in infants, and ways to develop feeding and settling routines before the onset of problems-could prevent such problems. This paper outlines the protocol for our study which aims to test an anticipatory guidance approach.
Methods/Design
750 families from four Local Government Areas in Melbourne, Australia have been randomised to receive the Baby Business program (intervention group) or usual care (control group) offered by health services. The Baby Business program provides parents with information about infant sleep and crying via a DVD and booklet (mailed soon after birth), telephone consultation (at infant age 6-8 weeks) and parent group session (at infant age 12 weeks). All English speaking parents of healthy newborn infants born at > 32 weeks gestation and referred by their maternal and child health nurse at their first post partum home visit (day 7-10 postpartum), are eligible. The primary outcome is parent report of infant night time sleep as a problem at four months of age and secondary outcomes include parent report of infant daytime sleep or crying as a problem, mean duration of infant sleep and crying/24 hours, parental depression symptoms, parent sleep quality and quantity and health service use. Data will be collected at two weeks (baseline), four months and six months of age. An economic evaluation using a cost-consequences approach will, from a societal perspective, compare costs and health outcomes between the intervention and control groups.
Discussion
To our knowledge this is the first randomised controlled trial of a program which aims to prevent both infant sleeping and crying problems and associated postnatal depression symptoms. If effective, it could offer an important public health prevention approach to these common, distressing problems.
Trial registration number
ISRCTN: ISRCTN63834603
doi:10.1186/1471-2431-12-13
PMCID: PMC3292472  PMID: 22309617
2.  Improving infant sleep and maternal mental health: a cluster randomised trial 
Archives of Disease in Childhood  2006;92(11):952-958.
Objectives
To determine whether a community‐delivered intervention targeting infant sleep problems improves infant sleep and maternal well‐being and to report the costs of this approach to the healthcare system.
Design
Cluster randomised trial.
Setting
49 Maternal and Child Health (MCH) centres (clusters) in Melbourne, Australia.
Participants
328 mothers reporting an infant sleep problem at 7 months recruited during October–November 2003.
Intervention
Behavioural strategies delivered over individual structured MCH consultations versus usual care.
Main outcome measures
Maternal report of infant sleep problem, depression symptoms (Edinburgh Postnatal Depression Scale (EPDS)), and SF‐12 mental and physical health scores when infants were 10 and 12 months old. Costs included MCH sleep consultations, other healthcare services and intervention costs.
Results
Prevalence of infant sleep problems was lower in the intervention than control group at 10 months (56% vs 68%; adjusted OR 0.58 (95% CI: 0.36 to 0.94)) and 12 months (39% vs 55%; adjusted OR 0.50 (0.31 to 0.80)). EPDS scores indicated less depression at 10 months (adjusted mean difference −1.4 (−2.3 to −0.4) and 12 months (−1.7 (−2.6 to −0.7)). SF‐12 mental health scores indicated better health at 10 months (adjusted mean difference 3.7 (1.5 to 5.8)) and 12 months (3.9 (1.8 to 6.1)). Total mean costs including intervention design, delivery and use of non‐MCH nurse services were £96.93 and £116.79 per intervention and control family, respectively.
Conclusions
Implementing this sleep intervention may lead to health gains for infants and mothers and resource savings for the healthcare system.
Trial registration
Current Controlled Trial Registry, number ISRCTN48752250 (registered November 2004).
doi:10.1136/adc.2006.099812
PMCID: PMC2083609  PMID: 17158146
3.  Effect of behavioural-educational intervention on sleep for primiparous women and their infants in early postpartum: multisite randomised controlled trial 
Objective To evaluate the effectiveness of a behavioural-educational sleep intervention delivered in the early postpartum in improving maternal and infant sleep.
Design Randomised controlled trial.
Setting Postpartum units of two university affiliated hospitals.
Participants 246 primiparous women and their infants randomised while in hospital with an internet based randomisation service to intervention (n=123) or usual care (n=123) groups.
Interventions The behavioural-educational sleep intervention included a 45-60 minute meeting with a nurse to discuss sleep information and strategies to promote maternal and infant sleep, a 20 page booklet with the content discussed, and phone contacts at one, two, and four weeks postpartum to reinforce information, provide support, and problem solve. The usual care group received calls at weeks one, two, and four to maintain contact without provision of advice.
Main outcome measures Primary outcome was maternal nocturnal (9 pm to 9 am) sleep (minutes) and secondary outcome was longest stretch of infant nocturnal sleep (minutes) measured at six and 12 weeks postpartum by actigraphy. Other outcomes measured at six and 12 weeks were number of maternal and infant night time awakenings by actigraphy, fatigue visual analogue scale, general sleep disturbance scale, and Edinburgh postnatal depression scale. Rates of exclusive breast feeding were measured at 12 weeks postpartum only.
Results All women who completed any outcome measures at six or 12 weeks were included in analysis. Sleep outcomes were completed at one or both of six and 12 weeks postpartum for 215 of 246 (87%) women (110/123 intervention and 105/123 usual care). Longitudinal mixed effects model analyses indicated no significant differences between the groups on any of the outcomes. The estimated mean difference in maternal nocturnal sleep between the intervention and usual care groups was 5.97 minutes (95% confidence interval −7.55 to 19.5 minutes, P=0.39). No differences in any outcomes were noted based on the specific nurse delivering the intervention or the number of phone contacts received.
Conclusion A behavioural-educational intervention delivered in the early postpartum, in hospital, and in the first weeks at home, was ineffective in improving maternal and infant sleep or other health outcomes in the first months postpartum.
Trial registration ISRCT No 13501166.
doi:10.1136/bmj.f1164
PMCID: PMC3603553  PMID: 23516146
4.  Effect of behavioural-educational intervention on sleep for primiparous women and their infants in early postpartum: multisite randomised controlled trial 
The BMJ  2013;346:f1164.
Objective To evaluate the effectiveness of a behavioural-educational sleep intervention delivered in the early postpartum in improving maternal and infant sleep.
Design Randomised controlled trial.
Setting Postpartum units of two university affiliated hospitals.
Participants 246 primiparous women and their infants randomised while in hospital with an internet based randomisation service to intervention (n=123) or usual care (n=123) groups.
Interventions The behavioural-educational sleep intervention included a 45-60 minute meeting with a nurse to discuss sleep information and strategies to promote maternal and infant sleep, a 20 page booklet with the content discussed, and phone contacts at one, two, and four weeks postpartum to reinforce information, provide support, and problem solve. The usual care group received calls at weeks one, two, and four to maintain contact without provision of advice.
Main outcome measures Primary outcome was maternal nocturnal (9 pm to 9 am) sleep (minutes) and secondary outcome was longest stretch of infant nocturnal sleep (minutes) measured at six and 12 weeks postpartum by actigraphy. Other outcomes measured at six and 12 weeks were number of maternal and infant night time awakenings by actigraphy, fatigue visual analogue scale, general sleep disturbance scale, and Edinburgh postnatal depression scale. Rates of exclusive breast feeding were measured at 12 weeks postpartum only.
Results All women who completed any outcome measures at six or 12 weeks were included in analysis. Sleep outcomes were completed at one or both of six and 12 weeks postpartum for 215 of 246 (87%) women (110/123 intervention and 105/123 usual care). Longitudinal mixed effects model analyses indicated no significant differences between the groups on any of the outcomes. The estimated mean difference in maternal nocturnal sleep between the intervention and usual care groups was 5.97 minutes (95% confidence interval −7.55 to 19.5 minutes, P=0.39). No differences in any outcomes were noted based on the specific nurse delivering the intervention or the number of phone contacts received.
Conclusion A behavioural-educational intervention delivered in the early postpartum, in hospital, and in the first weeks at home, was ineffective in improving maternal and infant sleep or other health outcomes in the first months postpartum.
Trial registration ISRCT No 13501166.
doi:10.1136/bmj.f1164
PMCID: PMC3603553  PMID: 23516146
5.  Prevention of Overweight in Infancy (POI.nz) study: a randomised controlled trial of sleep, food and activity interventions for preventing overweight from birth 
BMC Public Health  2011;11:942.
Background
Rapid weight gain during the first three years of life predicts child and adult obesity, and also later cardiovascular and other morbidities. Cross-sectional studies suggest that infant diet, activity and sleep are linked to excessive weight gain. As intervention for overweight children is difficult, the aim of the Prevention of Overweight in Infancy (POI.nz) study is to evaluate two primary prevention strategies during late pregnancy and early childhood that could be delivered separately or together as part of normal health care.
Methods/Design
This four-arm randomised controlled trial is being conducted with 800 families recruited at booking in the only maternity unit in the city of Dunedin, New Zealand. Mothers are randomised during pregnancy to either a usual care group (7 core contacts with a provider of government funded "Well Child" care over 2 years) or to one of three intervention groups given education and support in addition to "Well Child" care: the Food, Activity and Breastfeeding group which receives 8 extra parent contacts over the first 2 years of life; the Sleep group which receives at least 3 extra parent contacts over the first 6 months of life with a focus on prevention of sleep problems and then active intervention if there is a sleep problem from 6 months to 2 years; or the Combination group which receives all extra contacts. The main outcome measures are conditional weight velocity (0-6, 6-12, 12-24 months) and body mass index z-score at 24 months, with secondary outcomes including sleep and physical activity (parent report, accelerometry), duration of breastfeeding, timing of introduction of solids, diet quality, and measures of family function and wellbeing (parental depression, child mindedness, discipline practices, family quality of life and health care use). This study will contribute to a prospective meta-analysis of early life obesity prevention studies in Australasia.
Discussion
Infancy is likely to be the most effective time to establish patterns of behaviour around food, activity and sleep that promote healthy child and adult weight. The POI.nz study will determine the extent to which sleep, food and activity interventions in infancy prevent the development of overweight.
Trial Registration
Clinical Trials NCT00892983
Prospective meta-analysis registered on PROSPERO CRD420111188. Available from http://www.crd.york.ac.uk/PROSPERO
doi:10.1186/1471-2458-11-942
PMCID: PMC3293097  PMID: 22182309
6.  A randomized controlled trial of an intervention for infants’ behavioral sleep problems 
BMC Pediatrics  2015;15:181.
Background
Infant behavioral sleep problems are common, with potential negative consequences. We conducted a randomized controlled trial to assess effects of a sleep intervention comprising a two-hour group teaching session and four support calls over 2 weeks. Our primary outcomes were reduced numbers of nightly wakes or parent report of sleep problem severity. Secondary outcomes included improvement in parental depression, fatigue, sleep, and parent cognitions about infant sleep.
Methods
Two hundred thirty five families of six-to-eight month-old infants were randomly allocated to intervention (n = 117) or to control teaching sessions (n = 118) where parents received instruction on infant safety. Outcome measures were observed at baseline and at 6 weeks post intervention. Nightly observation was based on actigraphy and sleep diaries over six days. Secondary outcomes were derived from the Multidimensional Assessment of Fatigue Scale, Center for Epidemiologic Studies Depression Measure, Pittsburgh Sleep Quality Index, and Maternal (parental) Cognitions about Infant Sleep Questionnaire.
Results
One hundred eight intervention and 107 control families provided six-week follow-up information with complete actigraphy data for 96 in each group: 96.9 % of intervention and 97.9 % of control infants had an average of 2 or more nightly wakes, a risk difference of −0.2 % (95 % CI: −1.32, 0.91). 4 % of intervention and 14 % of control infants had parent-assessed severe sleep problems: relative risk 0.3, a risk difference of −10 % (CI: 0.11, 0.84-16.8 to −2.2). Relative to controls, intervention parents reported improved baseline-adjusted parental depression (CI: −3.7 to −0.4), fatigue (CI: −5.74 to −1.68), sleep quality (CI: −1.5 to −0.2), and sleep cognitions: doubts (CI: −2.0 to −0.6), feeding (CI: − 2.1 to - 0.7), anger (CI: − 1.8 to - 0.4) and setting limits (CI: −3.5 to −1.5).
Conclusions
The intervention improved caregivers' assessments of infant sleep problem severity and parental depression, fatigue, sleep, and sleep cognitions compared with controls.
Trial registration
ISRCTN42169337, NCT00877162
doi:10.1186/s12887-015-0492-7
PMCID: PMC4643535  PMID: 26567090
Randomized controlled trial; Multi-component intervention; Behavioral sleep problems; Infants; Actigraphy; Diaries; Parents
7.  Sleep education during pregnancy for new mothers 
Background
There is a high association between disturbed (poor quality) sleep and depression, which has lead to a consensus that there is a bidirectional relationship between sleep and mood. One time in a woman’s life when sleep is commonly disturbed is during pregnancy and following childbirth. It has been suggested that sleep disturbance is another factor that may contribute to the propensity for women to become depressed in the postpartum period compared to other periods in their life. Post Natal Depression (PND) is common (15.5%) and associated with sleep disturbance, however, no studies have attempted to provide a sleep-focused intervention to pregnant women and assess whether this can improve sleep, and consequently maternal mood post-partum. The primary aim of this research is to determine the efficacy of a brief psychoeducational sleep intervention compared with a control group to improve sleep management, with a view to reduce depressive symptoms in first time mothers.
Method
This randomised controlled trial will recruit 214 first time mothers during the last trimester of their pregnancy. Participants will be randomised to receive either a set of booklets (control group) or a 3hour psychoeducational intervention that focuses on sleep. The primary outcomes of this study are sleep-related, that is sleep quality and sleepiness for ten months following the birth of the baby. The secondary outcome is depressive symptoms. It is hypothesised that participants in the intervention group will have better sleep quality and sleepiness in the postpartum period than women in the control condition. Further, we predict that women who receive the sleep intervention will have lower depression scores postpartum compared with the control group.
Discussion
This study aims to provide an intervention that will improve maternal sleep in the postpartum period. If sleep can be effectively improved through a brief psychoeducational program, then it may have a protective role in reducing maternal postpartum depressive symptoms.
Registration details
This trial is registered with the Australian New Zealand Clinical Trials Register under the registration number ACTRN12611000859987
doi:10.1186/1471-2393-12-155
PMCID: PMC3546917  PMID: 23244163
Sleep; New mothers; Postnatal; Postpartum; Depression; Psychoeducation
8.  Comparison of methods for recruiting and engaging parents in online interventions: study protocol for the Cry Baby infant sleep and settling program 
BMC Pediatrics  2015;15:174.
Background
Anticipatory guidance around the management of sleep and crying problems in early infancy has been shown to improve both infant behaviour and parent symptoms of postnatal depression. Digital technology offers platforms for making such programs widely available in a cost-efficient manner. However, it remains unclear who accesses online parenting advice and in particular, whether the parents who would most benefit are represented amongst users. It is also unknown whether the uptake of online programs can be improved by health professional recommendations, or whether parents require additional prompts and reminders to use the program. In this study we aim to: (1) determine whether weekly email prompts increase engagement with and use of a brief online program about infant sleeping and crying, (2) determine whether encouragement from a maternal and child health nurse promotes greater engagement with and use of the program, (3) examine who uses a brief online program about infant sleeping and crying; and, (4) examine the psychosocial characteristics of participants.
Methods/Design
This study is a randomised, parallel group, superiority trial, with all participating primary carers of infants aged 2 to 12 weeks, receiving access to the online program. Two modes of recruitment will be compared: recruitment via an online notice published on a non-commercial, highly credible and evidence-based website for parents and carers and via the parent’s Maternal and Child Health nurse. After baseline assessment, parents will be randomised to one of two support conditions: online program alone or online program plus weekly email prompts. Follow up data will be collected at 4 months of infant age.
Discussion
Results from this trial will indicate whether involvement from a health professional, and/or ongoing email contact is necessary to engage parents in a brief online intervention, and promote parental use of strategies suggested within the program. Results of this trial will inform the development of recruitment and engagement strategies for other online interventions.
Trial registration
Australian New Zealand Clinical Trials Registry: ACTRN12613001098729. Registered 01 October 2013.
doi:10.1186/s12887-015-0502-9
PMCID: PMC4640160  PMID: 26556032
Infant; Sleep; Crying; Online; Intervention; Parents
9.  Early intervention to protect the mother-infant relationship following postnatal depression: study protocol for a randomised controlled trial 
Trials  2014;15:385.
Background
At least 13% of mothers experience depression in the first postnatal year, with accompanying feelings of despair and a range of debilitating symptoms. Serious sequelae include disturbances in the mother-infant relationship and poor long-term cognitive and behavioural outcomes for the child. Surprisingly, treatment of maternal symptoms of postnatal depression does not improve the mother-infant relationship for a majority of women. Targeted interventions to improve the mother-infant relationship following postnatal depression are scarce and, of those that exist, the majority are not evaluated in randomised controlled trials. This study aims to evaluate a brief targeted mother-infant intervention, to follow cognitive behavioural therapy treatment of postnatal depression, which has the potential to improve developmental outcomes of children of depressed mothers.
Methods/Design
The proposed study is a two-arm randomised controlled trial with follow-up to 6 months. One hundred participants will be recruited via referrals from health professionals including maternal and child health nurses and general practitioners, as well as self-referrals from women who have seen promotional materials for the study. Women who meet inclusion criteria (infant aged <12 months, women 18+ years of age) will complete the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-IV-TR Axis I Disorders. Those with a clinical diagnosis of current major or minor depressive disorder and who do not meet exclusion criteria (that is, currently receiving treatment for depression, significant difficulty with English, medium to high suicide risk, current self-harm, current substance abuse, current post-traumatic stress disorder, current manic/hypomanic episode or psychotic symptoms) will be randomised to receive either a 4-session mother-infant intervention (HUGS: Happiness Understanding Giving and Sharing) or a 4-session attention placebo playgroup (Playtime) following a 12-session postnatal depression group treatment programme. Primary outcome measures are the Parenting Stress Index (self-report measure) and the Parent-child Early Relational Assessment (observational measure coded by a blinded observer). Measurements are taken at baseline, after the postnatal depression programme, post-HUGS/Playtime, and at 6 months post-HUGS/Playtime.
Discussion
This research addresses the need for specific treatment for mother-infant interactional difficulties following postnatal depression. There is a need to investigate interventions in randomised trials to prevent detrimental effects on child development and make available evidence-based treatments.
Trial registration
Australia and New Zealand Clinical Trials Register: ACTRN12612001110875. Date Registered: 17 October 2012.
Electronic supplementary material
The online version of this article (doi:10.1186/1745-6215-15-385) contains supplementary material, which is available to authorized users.
doi:10.1186/1745-6215-15-385
PMCID: PMC4195961  PMID: 25277158
Postnatal depression; Mother-infant difficulties; Randomised controlled trial
10.  The effectiveness of massage therapy in the treatment of infantile colic symptoms: A randomized controlled trial 
Background: Infantile colic, cry-fuss and sleep problems are transient in the initial months of life, but they contribute to maternal depression, parenting stress and family mental health problems. In this randomized clinical trial, we aimed to explore the efficacy of massage therapy compared to rocking in reducing infantile colic symptoms including duration and number of cries, sleep duration and severity of infant colic.
Methods: This was a single blind RCT study with a one-week follow-up. One hundred colicky infants aged younger than 12 weeks old were randomly assigned into massage and rocking groups. Infants in the massage group received a massage for 15-20 minutes once during a day and once at night before sleeping for a week. In the control group, mothers rocked their infants gently for 5-25 minutes when the symptoms of colic appeared. Parents recorded the details of the colic symptoms in a diary every day. A GEE approach was applied to explore the effect of the intervention.
Results: Efficiency of massage therapy was significantly higher than rocking. At the end of the study, the mean number of daily cries was 4.26±1.40 in the massage and 6.9±2.14 the rocking groups (p<0.01). The mean of the severity score was 1.39±0.19 less in the massage group (p<0.01). Moreover, the mean differences of massage and rocking groups were -0.82±0.20 hour (p<0.01) and 0.72±0.35 (p= 0.04) in the duration of cries and duration of sleep, respectively.
Conclusion: Massaging significantly improved colic symptoms during a one-week intervention for all outcomes. In addition, significant differences were found between the intervention and control groups in favor of massaging. Therefore, massage therapy is more effective than rocking for treating infant colic symptoms.
PMCID: PMC4934450  PMID: 27453882
Colic; Massage; Clinical Trial; Pediatrics
11.  Comparative Efficacy of Seven Psychotherapeutic Interventions for Patients with Depression: A Network Meta-Analysis 
PLoS Medicine  2013;10(5):e1001454.
Jürgen Barth and colleagues use network meta-analysis - a novel methodological approach - to reexamine the comparative efficacy of seven psychotherapeutic interventions for adults with depression.
Please see later in the article for the Editors' Summary
Background
Previous meta-analyses comparing the efficacy of psychotherapeutic interventions for depression were clouded by a limited number of within-study treatment comparisons. This study used network meta-analysis, a novel methodological approach that integrates direct and indirect evidence from randomised controlled studies, to re-examine the comparative efficacy of seven psychotherapeutic interventions for adult depression.
Methods and Findings
We conducted systematic literature searches in PubMed, PsycINFO, and Embase up to November 2012, and identified additional studies through earlier meta-analyses and the references of included studies. We identified 198 studies, including 15,118 adult patients with depression, and coded moderator variables. Each of the seven psychotherapeutic interventions was superior to a waitlist control condition with moderate to large effects (range d = −0.62 to d = −0.92). Relative effects of different psychotherapeutic interventions on depressive symptoms were absent to small (range d = 0.01 to d = −0.30). Interpersonal therapy was significantly more effective than supportive therapy (d = −0.30, 95% credibility interval [CrI] [−0.54 to −0.05]). Moderator analysis showed that patient characteristics had no influence on treatment effects, but identified aspects of study quality and sample size as effect modifiers. Smaller effects were found in studies of at least moderate (Δd = 0.29 [−0.01 to 0.58]; p = 0.063) and large size (Δd = 0.33 [0.08 to 0.61]; p = 0.012) and those that had adequate outcome assessment (Δd = 0.38 [−0.06 to 0.87]; p = 0.100). Stepwise restriction of analyses by sample size showed robust effects for cognitive-behavioural therapy, interpersonal therapy, and problem-solving therapy (all d>0.46) compared to waitlist. Empirical evidence from large studies was unavailable or limited for other psychotherapeutic interventions.
Conclusions
Overall our results are consistent with the notion that different psychotherapeutic interventions for depression have comparable benefits. However, the robustness of the evidence varies considerably between different psychotherapeutic treatments.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Depression is a very common condition. One in six people will experience depression at some time during their life. People who are depressed have recurrent feelings of sadness and hopelessness and might feel that life is no longer worth living. The condition can last for months and often includes physical symptoms such as headaches, sleeping problems, and weight gain or loss. Treatment of depression can include non-drug treatments (psychotherapy), antidepressant drugs, or a combination of the two. Especially for people with mild or intermediate depression, psychotherapy is often considered the preferred first option. Psychotherapy describes a range of different psychotherapies, and a number of established types of psychotherapies have all shown to work for at least some patients.
Why Was This Study Done?
While it is broadly accepted that psychotherapy can help people with depression, the question of which type of psychotherapy works best for most patients remains controversial. While many scientific studies have compared one psychotherapy with control conditions, there have been few studies that directly compared multiple treatments. Without such direct comparisons, it has been difficult to establish the respective merits of the different types of psychotherapy. Taking advantage of a recently developed method called “network meta-analysis,” the authors re-examine the evidence on seven different types of psychotherapy to see how well they have been shown to work and whether some work better than others.
What Did the Researchers Do and Find?
The researchers looked at seven different types of psychotherapy, which they defined as follows. “Interpersonal psychotherapy” is short and highly structured, using a manual to focus on interpersonal issues in depression. “Behavioral activation” raises the awareness of pleasant activities and seeks to increase positive interactions between the patient and his or her environment. “Cognitive behavioral therapy” focuses on a patient's current negative beliefs, evaluates how they affect current and future behavior, and attempts to restructure the beliefs and change the outlook. “Problem solving therapy” aims to define a patient's problems, propose multiple solutions for each problem, and then select, implement, and evaluate the best solution. “Psychodynamic therapy” focuses on past unresolved conflicts and relationships and the impact they have on a patient's current situation. In “social skills therapy,” patients are taught skills that help to build and maintain healthy relationships based on honesty and respect. “Supportive counseling” is a more general therapy that aims to get patients to talk about their experiences and emotions and to offer empathy without suggesting solutions or teaching new skills.
The researchers started with a systematic search of the medical literature for relevant studies. The search identified 198 articles that reported on such clinical trials. The trials included a total of 15,118 patients and compared one of the seven psychotherapies either with another one or with a common “control intervention”. In most cases, the control (no psychotherapy) was deferral of treatment by “wait-listing” patients or continuing “usual care.” With network meta-analysis they were able to summarize the results of all these trials in a meaningful way. They did this by integrating direct comparisons of several psychotherapies within the same trial (where those were available) with indirect comparisons across all trials (using no psychotherapy as a control intervention).
Based on the combined trial results, all seven psychotherapies tested were better than wait-listing or usual care, and the differences were moderate to large, meaning that the average person in the group that received therapy was better off than about half of the patients in the control group. When comparing the therapies with each other, the researchers saw small or no differences, meaning that none of them really stood out as much better or much worse than the others. They also found that the treatments worked equally well for different patient groups with depression (younger or older patients, or mothers who had depression after having given birth). Similarly, they saw no big differences when comparing individual with group therapy, or person-to-person with internet-based interactions between therapist and patient.
However, they did find that smaller and less rigorous studies generally found larger benefits of psychotherapies, and most of the studies included in the analysis were small. Only 36 of the studies had at least 50 patients who received the same treatment. When they restricted their analysis to those studies, the researchers still saw clear benefits of cognitive-behavioral therapy, interpersonal therapy, and problem-solving therapy, but not for the other four therapies.
What Do these Findings Mean?
Similar to earlier attempts to summarize and make sense of the many study results, this one finds benefits for all of the seven psychotherapies examined, and none of them stood as being much better than some or all others. The scientific support for being beneficial was stronger for some therapies, mostly because they had been tested more often and in larger studies.
Treatments with proven benefits still do not necessarily work for all patients, and which type of psychotherapy might work best for a particular patient likely depends on that individual. So overall this analysis suggests that patients with depression and their doctors should consider psychotherapies and explore which of the different types might be best suited for a particular patient.
The study also points to the need for further research. Whereas depression affects large numbers of people around the world, all of the trials identified were conducted in rich countries and Western societies. Trials in different settings are essential to inform treatment of patients worldwide. In addition, large high-quality studies should further explore the potential benefits of some of therapies for which less support currently exists. Where possible, future studies should compare psychotherapies with one another, because all of them have benefits, and it would not be ethical to withhold such beneficial treatment from patients.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001454.
The US National Institute of Mental Health provides information on all aspects of depression (in English and Spanish); information on psychotherapy includes information on its most common forms
The UK National Health Service Choices website also provides detailed information about depression and includes personal stories about depression
The UK nonprofit Mind provides information on depression, including an explanation of the most common psychotherapies in the UK
MedlinePlus provides links to other resources about depression (in English and Spanish)
The UK nonprofit healthtalkonline.org has a unique database of personal and patient experiences on depression
doi:10.1371/journal.pmed.1001454
PMCID: PMC3665892  PMID: 23723742
12.  Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial 
Objective To determine whether the probiotic Lactobacillus reuteri DSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months.
Design Double blind, placebo controlled randomised trial.
Setting Community based sample (primary and secondary level care centres) in Melbourne, Australia.
Participants 167 breastfed infants or formula fed infants aged less than 3 months meeting Wessel’s criteria for crying or fussing: 85 were randomised to receive probiotic and 82 to receive placebo.
Interventions Oral daily L reuteri (1×108 colony forming units) versus placebo for one month.
Main outcomes measures The primary outcome was daily duration of cry or fuss at 1 month. Secondary outcomes were duration of cry or fuss; number of cry or fuss episodes; sleep duration of infant at 7, 14, and 21 days, and 1 and 6 months; maternal mental health (Edinburgh postnatal depression subscale); family functioning (paediatric quality of life inventory), parent quality adjusted life years (assessment of quality of life) at 1 and 6 months; infant functioning (paediatric quality of life inventory) at 6 months; infant faecal microbiota (microbial diversity, colonisation with Escherichia coli), and calprotectin levels at 1 month. In intention to treat analyses the two groups were compared using regression models adjusted for potential confounders.
Results Of 167 infants randomised from August 2011 to August 2012, 127 (76%) were retained to primary outcome; of these, a subset was analysed for faecal microbial diversity, E coli colonisation, and calprotectin levels. Adherence was high. Mean daily cry or fuss time fell steadily in both groups. At 1 month, the probiotic group cried or fussed 49 minutes more than the placebo group (95% confidence interval 8 to 90 minutes, P=0.02); this mainly reflected more fussing, especially for formula fed infants. The groups were similar on all secondary outcomes. No study related adverse events occurred.
Conclusions L reuteri DSM 17938 did not benefit a community sample of breastfed infants and formula fed infants with colic. These findings differ from previous smaller trials of selected populations and do not support a general recommendation for the use of probiotics to treat colic in infants.
Trial registration Current Controlled Trials ISRCTN95287767.
doi:10.1136/bmj.g2107
PMCID: PMC3972414  PMID: 24690625
13.  Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial 
The BMJ  2014;348:g2107.
Objective To determine whether the probiotic Lactobacillus reuteri DSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months.
Design Double blind, placebo controlled randomised trial.
Setting Community based sample (primary and secondary level care centres) in Melbourne, Australia.
Participants 167 breastfed infants or formula fed infants aged less than 3 months meeting Wessel’s criteria for crying or fussing: 85 were randomised to receive probiotic and 82 to receive placebo.
Interventions Oral daily L reuteri (1×108 colony forming units) versus placebo for one month.
Main outcomes measures The primary outcome was daily duration of cry or fuss at 1 month. Secondary outcomes were duration of cry or fuss; number of cry or fuss episodes; sleep duration of infant at 7, 14, and 21 days, and 1 and 6 months; maternal mental health (Edinburgh postnatal depression subscale); family functioning (paediatric quality of life inventory), parent quality adjusted life years (assessment of quality of life) at 1 and 6 months; infant functioning (paediatric quality of life inventory) at 6 months; infant faecal microbiota (microbial diversity, colonisation with Escherichia coli), and calprotectin levels at 1 month. In intention to treat analyses the two groups were compared using regression models adjusted for potential confounders.
Results Of 167 infants randomised from August 2011 to August 2012, 127 (76%) were retained to primary outcome; of these, a subset was analysed for faecal microbial diversity, E coli colonisation, and calprotectin levels. Adherence was high. Mean daily cry or fuss time fell steadily in both groups. At 1 month, the probiotic group cried or fussed 49 minutes more than the placebo group (95% confidence interval 8 to 90 minutes, P=0.02); this mainly reflected more fussing, especially for formula fed infants. The groups were similar on all secondary outcomes. No study related adverse events occurred.
Conclusions L reuteri DSM 17938 did not benefit a community sample of breastfed infants and formula fed infants with colic. These findings differ from previous smaller trials of selected populations and do not support a general recommendation for the use of probiotics to treat colic in infants.
Trial registration Current Controlled Trials ISRCTN95287767.
doi:10.1136/bmj.g2107
PMCID: PMC3972414  PMID: 24690625
14.  The effectiveness of video interaction guidance in parents of premature infants: A multicenter randomised controlled trial 
BMC Pediatrics  2012;12:76.
Background
Studies have consistently found a high incidence of neonatal medical problems, premature births and low birth weights in abused and neglected children. One of the explanations proposed for the relation between neonatal problems and adverse parenting is a possible delay or disturbance in the bonding process between the parent and infant. This hypothesis suggests that due to neonatal problems, the development of an affectionate bond between the parent and the infant is impeded. The disruption of an optimal parent-infant bond -on its turn- may predispose to distorted parent-infant interactions and thus facilitate abusive or neglectful behaviours. Video Interaction Guidance (VIG) is expected to promote the bond between parents and newborns and is expected to diminish non-optimal parenting behaviour.
Methods/design
This study is a multi-center randomised controlled trial to evaluate the effectiveness of Video Interaction Guidance in parents of premature infants. In this study 210 newborn infants with their parents will be included: n = 70 healthy term infants (>37 weeks GA), n = 70 moderate term infants (32–37 weeks GA) which are recruited from maternity wards of 6 general hospitals and n = 70 extremely preterm infants or very low birth weight infants (<32 weeks GA) recruited by the NICU of 2 specialized hospitals. The participating families will be divided into 3 groups: a reference group (i.e. full term infants and their parents, receiving care as usual), a control group (i.e. premature infants and their parents, receiving care as usual) and an intervention group (i.e. premature infants and their parents, receiving VIG). The data will be collected during the first six months after birth using observations of parent-infant interactions, questionnaires and semi-structured interviews. Primary outcomes are the quality of parental bonding and parent-infant interactive behaviour. Parental secondary outcomes are (posttraumatic) stress symptoms, depression, anxiety and feelings of anger and hostility. Infant secondary outcomes are behavioral aspects such as crying, eating, and sleeping.
Discussion
This is the first prospective study to empirically evaluate the effect of VIG in parents of premature infants. Family recruitment is expected to be completed in January 2012. First results should be available by 2012.
Trail registration number
NTR3423
doi:10.1186/1471-2431-12-76
PMCID: PMC3464160  PMID: 22709245
15.  Impact of a behavioural sleep intervention on symptoms and sleep in children with attention deficit hyperactivity disorder, and parental mental health: randomised controlled trial 
Objective To examine whether behavioural strategies designed to improve children’s sleep problems could also improve the symptoms, behaviour, daily functioning, and working memory of children with attention deficit hyperactivity disorder (ADHD) and the mental health of their parents.
Design Randomised controlled trial.
Setting 21 general paediatric practices in Victoria, Australia.
Participants 244 children aged 5-12 years with ADHD attending the practices between 2010 and 2012.
Intervention Sleep hygiene practices and standardised behavioural strategies delivered by trained psychologists or trainee paediatricians during two fortnightly consultations and a follow-up telephone call. Children in the control group received usual clinical care.
Main outcome measures At three and six months after randomisation: severity of ADHD symptoms (parent and teacher ADHD rating scale IV—primary outcome), sleep problems (parent reported severity, children’s sleep habits questionnaire, actigraphy), behaviour (strengths and difficulties questionnaire), quality of life (pediatric quality of life inventory 4.0), daily functioning (daily parent rating of evening and morning behavior), working memory (working memory test battery for children, six months only), and parent mental health (depression anxiety stress scales).
Results Intervention compared with control families reported a greater decrease in ADHD symptoms at three and six months (adjusted mean difference for change in symptom severity −2.9, 95% confidence interval −5.5 to −0.3, P=0.03, effect size −0.3, and −3.7, −6.1 to −1.2, P=0.004, effect size −0.4, respectively). Compared with control children, intervention children had fewer moderate-severe sleep problems at three months (56% v 30%; adjusted odds ratio 0.30, 95% confidence interval 0.16 to 0.59; P<0.001) and six months (46% v 34%; 0.58, 0.32 to 1.0; P=0.07). At three months this equated to a reduction in absolute risk of 25.7% (95% confidence interval 14.1% to 37.3%) and an estimated number needed to treat of 3.9. At six months the number needed to treat was 7.8. Approximately a half to one third of the beneficial effect of the intervention on ADHD symptoms was mediated through improved sleep, at three and six months, respectively. Intervention families reported greater improvements in all other child and family outcomes except parental mental health. Teachers reported improved behaviour of the children at three and six months. Working memory (backwards digit recall) was higher in the intervention children compared with control children at six months. Daily sleep duration measured by actigraphy tended to be higher in the intervention children at three months (mean difference 10.9 minutes, 95% confidence interval −19.0 to 40.8 minutes, effect size 0.2) and six months (9.9 minutes, −16.3 to 36.1 minutes, effect size 0.3); however, this measure was only completed by a subset of children (n=54 at three months and n=37 at six months).
Conclusions A brief behavioural sleep intervention modestly improves the severity of ADHD symptoms in a community sample of children with ADHD, most of whom were taking stimulant medications. The intervention also improved the children’s sleep, behaviour, quality of life, and functioning, with most benefits sustained to six months post-intervention. The intervention may be suitable for use in primary and secondary care.
Trial registration Current Controlled Trials ISRCTN68819261.
doi:10.1136/bmj.h68
PMCID: PMC4299655  PMID: 25646809
16.  Impact of a behavioural sleep intervention on symptoms and sleep in children with attention deficit hyperactivity disorder, and parental mental health: randomised controlled trial 
The BMJ  2015;350:h68.
Objective To examine whether behavioural strategies designed to improve children’s sleep problems could also improve the symptoms, behaviour, daily functioning, and working memory of children with attention deficit hyperactivity disorder (ADHD) and the mental health of their parents.
Design Randomised controlled trial.
Setting 21 general paediatric practices in Victoria, Australia.
Participants 244 children aged 5-12 years with ADHD attending the practices between 2010 and 2012.
Intervention Sleep hygiene practices and standardised behavioural strategies delivered by trained psychologists or trainee paediatricians during two fortnightly consultations and a follow-up telephone call. Children in the control group received usual clinical care.
Main outcome measures At three and six months after randomisation: severity of ADHD symptoms (parent and teacher ADHD rating scale IV—primary outcome), sleep problems (parent reported severity, children’s sleep habits questionnaire, actigraphy), behaviour (strengths and difficulties questionnaire), quality of life (pediatric quality of life inventory 4.0), daily functioning (daily parent rating of evening and morning behavior), working memory (working memory test battery for children, six months only), and parent mental health (depression anxiety stress scales).
Results Intervention compared with control families reported a greater decrease in ADHD symptoms at three and six months (adjusted mean difference for change in symptom severity −2.9, 95% confidence interval −5.5 to −0.3, P=0.03, effect size −0.3, and −3.7, −6.1 to −1.2, P=0.004, effect size −0.4, respectively). Compared with control children, intervention children had fewer moderate-severe sleep problems at three months (56% v 30%; adjusted odds ratio 0.30, 95% confidence interval 0.16 to 0.59; P<0.001) and six months (46% v 34%; 0.58, 0.32 to 1.0; P=0.07). At three months this equated to a reduction in absolute risk of 25.7% (95% confidence interval 14.1% to 37.3%) and an estimated number needed to treat of 3.9. At six months the number needed to treat was 7.8. Approximately a half to one third of the beneficial effect of the intervention on ADHD symptoms was mediated through improved sleep, at three and six months, respectively. Intervention families reported greater improvements in all other child and family outcomes except parental mental health. Teachers reported improved behaviour of the children at three and six months. Working memory (backwards digit recall) was higher in the intervention children compared with control children at six months. Daily sleep duration measured by actigraphy tended to be higher in the intervention children at three months (mean difference 10.9 minutes, 95% confidence interval −19.0 to 40.8 minutes, effect size 0.2) and six months (9.9 minutes, −16.3 to 36.1 minutes, effect size 0.3); however, this measure was only completed by a subset of children (n=54 at three months and n=37 at six months).
Conclusions A brief behavioural sleep intervention modestly improves the severity of ADHD symptoms in a community sample of children with ADHD, most of whom were taking stimulant medications. The intervention also improved the children’s sleep, behaviour, quality of life, and functioning, with most benefits sustained to six months post-intervention. The intervention may be suitable for use in primary and secondary care.
Trial registration Current Controlled Trials ISRCTN68819261.
doi:10.1136/bmj.h68
PMCID: PMC4299655  PMID: 25646809
17.  Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial 
BMC Psychiatry  2016;16(1):307.
Background
Sleep problems in childhood have been found to be associated with memory and learning impairments, irritability, difficulties in mood modulation, attention and behavioral problems, hyperactivity and impulsivity. Short sleep duration has been found to be associated with overweight and obesity in childhood. This paper describes the protocol of a behavioral intervention planned to promote healthier sleep in infants.
Methods
The study is a 1:1 parallel group single-blinded randomized controlled trial enrolling a total of 552 infants at 3 months of age. The main eligibility criterion is maternal report of the infant’s sleep lasting on average less than 15 h per 24 h (daytime and nighttime sleep). Following block randomization, trained fieldworkers conduct home visits of the intervention group mothers and provide standardized advice on general practices that promote infant’s self-regulated sleep. A booklet with the intervention content to aid the mother in implementing the intervention was developed and is given to the mothers in the intervention arm. In the two days following the home visit the intervention mothers receive daily telephone calls for intervention reinforcement and at day 3 the fieldworkers conduct a reinforcement visit to support mothers’ compliance with the intervention. The main outcome assessed is the between group difference in average nighttime self-regulated sleep duration (the maximum amount of time the child stays asleep or awake without awakening the parents), at ages 6, 12 and 24 months, evaluated by means of actigraphy, activity diary records and questionnaires. The secondary outcomes are conditional linear growth between age 3–12 and 12–24 months and neurocognitive development at ages 12 and 24 months.
Discussion
The negative impact of inadequate and insufficient sleep on children’s physical and mental health are unquestionable, as well as its impact on cognitive function, academic performance and behavior, all of these being factors to which children in low- and middle-income countries are at higher risk. Behavioral interventions targeting mothers and young children that can be delivered inexpensively and not requiring specialized training can help prevent future issues by reducing the risk to which these children are exposed.
Trial registration
ClinicalTrial.gov NCT02788630 registered on 14 June 2016 (retrospectively registered).
doi:10.1186/s12888-016-1016-1
PMCID: PMC5010682  PMID: 27590170
Sleep; Child development; Child growth
18.  A cluster randomised controlled trial of a brief couple-focused psychoeducational intervention to prevent common postnatal mental disorders among women: study protocol 
BMJ Open  2014;4(9):e006436.
Introduction
Postnatal common mental disorders among women are an important public health problem internationally. Interventions to prevent postnatal depression have had limited success. What Were We Thinking (WWWT) is a structured, gender-informed, psychoeducational group programme for parents and their first infant that addresses two modifiable risks to postnatal mental health. This paper describes the protocol for a cluster randomised controlled trial to test the clinical effectiveness and cost-effectiveness of WWWT when implemented in usual primary care.
Methods and analysis
48 maternal and child health (MCH) centres from six diverse Local Government Areas, in Victoria, Australia are randomly allocated to the intervention group (usual care plus WWWT) or the control group (usual care). The required sample size is 184 women in each group. English-speaking primiparous women receiving postpartum healthcare in participating MCH centres complete two computer-assisted telephone interviews: baseline at 4 weeks and outcome at 6 months postpartum. Women attending intervention MCH centres are invited to attend WWWT in addition to usual care. The primary outcome is meeting Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for major depressive episode; generalised anxiety disorder; panic disorder with or without agoraphobia, agoraphobia with or without panic, social phobia, adult separation anxiety or adjustment disorder with depressed mood, anxiety or mixed depressed mood and anxiety within the past 30 days at 6 months postpartum. Secondary outcomes are self-rated general and emotional health, infant sleep problems, method of infant feeding, quality of mother–infant relationship and intimate partner relationship, and healthcare costs and outcomes.
Ethics and dissemination
Approval to conduct the study has been granted. A comprehensive dissemination plan has been devised.
Trial registration number
Australian New Zealand Clinical Trials Registry ACTRN12613000506796.
UTN
U1111-1125-8208.
doi:10.1136/bmjopen-2014-006436
PMCID: PMC4173107  PMID: 25248497
MENTAL HEALTH; PRIMARY CARE; PREVENTIVE MEDICINE; PUBLIC HEALTH
19.  Cluster randomised trials in maternal and child health: implications for power and sample size 
BACKGROUND—Interventions based in the community can be evaluated by randomising clusters, such as general practices, rather than individuals, as in conventional randomised trials. This increases the sample size needed because of intracluster correlation.
AIMS—To estimate sample size requirements for cluster randomised trials of interventions based in general practice directed at common health problems affecting mothers and infants.
METHODS—Data were collected from a pilot trial of the effect of Citizen's Advice Bureau services involving six general practices. Outcome measures included the Edinburgh postnatal depression score, the Warwick child health and morbidity profile, number of visits to the general practitioner, and two questionnaires delivered at the beginning and end of the study. Intracluster correlation coefficients and inflation factors (the ratio of the sample size required for a cluster randomised trial to that required for an individually randomised trial) were calculated.
RESULTS—Intracluster correlation coefficients ranged from 0 (sleeping problems, accidental injury, hospitalisation) to 0.09 (maternal smoking), with most being < 0.04 (for example, maternal depression, breast feeding, general health, minor illness, behavioural problems, and visits to the general practitioner). Assuming 50 cases/practice, cluster randomised trials require sample sizes up to 3 times greater than individually randomised trials for most health outcomes measured.
CONCLUSIONS—These data enable sample sizes to be estimated for cluster randomised trials into a range of maternal and child health outcomes. Using such a design, approximately 40 practices would be sufficient to evaluate the effect of an intervention on maternal depression, sleeping, and behavioural problems, and non-routine visits to the general practitioner.


doi:10.1136/adc.82.1.79
PMCID: PMC1718186  PMID: 10630921
20.  Melatonin for sleep problems in children with neurodevelopmental disorders: randomised double masked placebo controlled trial 
Objective To assess the effectiveness and safety of melatonin in treating severe sleep problems in children with neurodevelopmental disorders.
Design 12 week double masked randomised placebo controlled phase III trial.
Setting 19 hospitals across England and Wales.
Participants 146 children aged 3 years to 15 years 8 months were randomised. They had a range of neurological and developmental disorders and a severe sleep problem that had not responded to a standardised sleep behaviour advice booklet provided to parents four to six weeks before randomisation. A sleep problem was defined as the child not falling asleep within one hour of lights out or having less than six hours’ continuous sleep.
Interventions Immediate release melatonin or matching placebo capsules administered 45 minutes before the child’s bedtime for a period of 12 weeks. All children started with a 0.5 mg capsule, which was increased through 2 mg, 6 mg, and 12 mg depending on their response to treatment.
Main outcome measures Total sleep time at night after 12 weeks adjusted for baseline recorded in sleep diaries completed by the parent. Secondary outcomes included sleep onset latency, assessments of child behaviour, family functioning, and adverse events. Sleep was measured with diaries and actigraphy.
Results Melatonin increased total sleep time by 22.4 minutes (95% confidence interval 0.5 to 44.3 minutes) measured by sleep diaries (n=110) and 13.3 (−15.5 to 42.2) measured by actigraphy (n=59). Melatonin reduced sleep onset latency measured by sleep diaries (−37.5 minutes, −55.3 to −19.7 minutes) and actigraphy (−45.3 minutes, −68.8 to −21.9 minutes) and was most effective for children with the longest sleep latency (P=0.009). Melatonin was associated with earlier waking times than placebo (29.9 minutes, 13.6 to 46.3 minutes). Child behaviour and family functioning outcomes showed some improvement and favoured use of melatonin. Adverse events were mild and similar between the two groups.
Conclusions Children gained little additional sleep on melatonin; though they fell asleep significantly faster, waking times became earlier. Child behaviour and family functioning outcomes did not significantly improve. Melatonin was tolerable over this three month period. Comparisons with slow release melatonin preparations or melatonin analogues are required.
Trial registration ISRCT No 05534585.
doi:10.1136/bmj.e6664
PMCID: PMC3489506  PMID: 23129488
21.  Melatonin for sleep problems in children with neurodevelopmental disorders: randomised double masked placebo controlled trial 
The BMJ  2012;345:e6664.
Objective To assess the effectiveness and safety of melatonin in treating severe sleep problems in children with neurodevelopmental disorders.
Design 12 week double masked randomised placebo controlled phase III trial.
Setting 19 hospitals across England and Wales.
Participants 146 children aged 3 years to 15 years 8 months were randomised. They had a range of neurological and developmental disorders and a severe sleep problem that had not responded to a standardised sleep behaviour advice booklet provided to parents four to six weeks before randomisation. A sleep problem was defined as the child not falling asleep within one hour of lights out or having less than six hours’ continuous sleep.
Interventions Immediate release melatonin or matching placebo capsules administered 45 minutes before the child’s bedtime for a period of 12 weeks. All children started with a 0.5 mg capsule, which was increased through 2 mg, 6 mg, and 12 mg depending on their response to treatment.
Main outcome measures Total sleep time at night after 12 weeks adjusted for baseline recorded in sleep diaries completed by the parent. Secondary outcomes included sleep onset latency, assessments of child behaviour, family functioning, and adverse events. Sleep was measured with diaries and actigraphy.
Results Melatonin increased total sleep time by 22.4 minutes (95% confidence interval 0.5 to 44.3 minutes) measured by sleep diaries (n=110) and 13.3 (−15.5 to 42.2) measured by actigraphy (n=59). Melatonin reduced sleep onset latency measured by sleep diaries (−37.5 minutes, −55.3 to −19.7 minutes) and actigraphy (−45.3 minutes, −68.8 to −21.9 minutes) and was most effective for children with the longest sleep latency (P=0.009). Melatonin was associated with earlier waking times than placebo (29.9 minutes, 13.6 to 46.3 minutes). Child behaviour and family functioning outcomes showed some improvement and favoured use of melatonin. Adverse events were mild and similar between the two groups.
Conclusions Children gained little additional sleep on melatonin; though they fell asleep significantly faster, waking times became earlier. Child behaviour and family functioning outcomes did not significantly improve. Melatonin was tolerable over this three month period. Comparisons with slow release melatonin preparations or melatonin analogues are required.
Trial registration ISRCT No 05534585.
doi:10.1136/bmj.e6664
PMCID: PMC3489506  PMID: 23129488
22.  The contribution of Australian residential early parenting centres to comprehensive mental health care for mothers of infants: evidence from a prospective study 
Background
Australia's public access residential early parenting services provide programs to assist parents who self-refer, to care for their infants and young children. Treatment programs target infant feeding and sleeping difficulties and maternal mental health. There is limited systematic evidence of maternal and infant mental health, psychosocial circumstances or presenting problems, or the effectiveness of the programs. The aim of this study was to contribute to the evidence base about residential early parenting services.
Methods
A prospective cohort design was used. A consecutive sample of mothers with infants under one year old recruited during admission to a public access residential early parenting service for a 4 or 5 night stay in Melbourne, Australia was recruited. They completed structured self-report questionnaires, incorporating standardised measures of infant behaviour and maternal mood, during admission and at one and six months after discharge. Changes in infant behaviour and maternal psychological functioning after discharge were observed.
Results
79 women completed the first questionnaire during admission, and 58 provided complete data. Women admitted to the residential program have poor physical and mental health, limited family support, and infants with substantial behaviour difficulties. One month after discharge significant improvements in infant behaviour and maternal psychological functioning were observed (mean (SD) daily crying and fussing during admission = 101.02 (100.8) minutes reduced to 37.7 (55.2) at one month post discharge, p < 0.001; mean (SD) Edinburgh Postnatal Depression Scale at admission = 11.3 (5.7) reduced to 6.78 (4.44), at one month, p < 0.001) which were sustained at six months. Participant satisfaction with the program was high; 58 (88%) found the support of the nurses and 50 (75%) the social support of other mothers very helpful.
Conclusions
This psycho-educational approach is an effective and acceptable early intervention for parenting difficulties and maternal mood disturbance, and contributes to a system of comprehensive mental health care for mothers of infants.
doi:10.1186/1752-4458-4-6
PMCID: PMC2873569  PMID: 20380739
23.  Does infant reactivity moderate the association between antenatal maternal depression and infant sleep? 
OBJECTIVE
A number of studies have established an association between antenatal maternal depression and infant sleep. One key question is whether all infants are equally susceptible to environmental influences, including the intra-uterine environment. Reactive temperament has been examined as a plasticity factor, with accumulating evidence suggesting that infants with reactive temperament may be more susceptible to both positive and negative environmental influences. This study examines whether infant reactivity moderates any association between antenatal depression and infant sleep in two longitudinal studies: the ALSPAC and Generation R cohorts.
METHODS
Maternal depression scores were assessed during pregnancy using the EPDS and BSI. Infant sleep duration and awakenings, in ALSPAC (N=8,318) and Generation R (N=2,241), were assessed at 18/24 months of age respectively. Infant reactivity was assessed by temperament questionnaire at 6 months of age.
RESULTS
Hierarchical linear regression models indicated a three-way interaction between reactivity and gender moderating the effect of antenatal depression on infant sleep; on sleep duration in Generation R at 24 months (β =.085, p<.001) in the whole sample and when limited to the Dutch/European group (β =.055, p=.030), and on night awakenings at 18 months in ALSPAC (β= −.085, p=.013).Boys with more reactive temperament exhibited shorter sleep duration and a higher number of awakenings when previously exposed to maternal symptoms of antenatal depression.
CONCLUSION
For the first time, these findings highlight, in two large cohorts, that children with temperamental reactivity may be more vulnerable to antenatal depression, raising the possibility of targeted interventions to improve infant outcomes.
doi:10.1097/DBP.0000000000000181
PMCID: PMC4497971  PMID: 26075582
infant sleep; temperament; antenatal depression; ALSPAC; Generation R
24.  Development of a universal psycho-educational intervention to prevent common postpartum mental disorders in primiparous women: a multiple method approach 
BMC Public Health  2010;10:499.
Background
Prevention of postnatal mental disorders in women is an important component of comprehensive health service delivery because of the substantial potential benefits for population health. However, diverse approaches to prevention of postnatal depression have had limited success, possibly because anxiety and adjustment disorders are also problematic, mental health problems are multifactorially determined, and because relationships amongst psychosocial risk factors are complex and difficult to modify. The aim of this paper is to describe the development of a novel psycho-educational intervention to prevent postnatal mental disorders in mothers of firstborn infants.
Methods
Data from a variety of sources were synthesised: a literature review summarised epidemiological evidence about neglected modifiable risk factors; clinical research evidence identified successful psychosocial treatments for postnatal mental health problems; consultations with clinicians, health professionals, policy makers and consumers informed the proposed program and psychological and health promotion theories underpinned the proposed mechanisms of effect. The intervention was pilot-tested with small groups of mothers and fathers and their first newborn infants.
Results
What Were We Thinking! is a psycho-educational intervention, designed for universal implementation, that addresses heightened learning needs of parents of first newborns. It re-conceptualises mental health problems in mothers of infants as reflecting unmet needs for adaptations in the intimate partner relationship after the birth of a baby, and skills to promote settled infant behaviour. It addresses these two risk factors in half-day seminars, facilitated by trained maternal and child health nurses using non-psychiatric language, in groups of up to five couples and their four-week old infants in primary care. It is designed to promote confidence and reduce mental disorders by providing skills in sustainable sleep and settling strategies, and the re-negotiation of the unpaid household workload in non-confrontational ways. Materials include a Facilitators' Handbook, creatively designed worksheets for use in seminars, and a book for couples to take home for reference. A website provides an alternative means of access to the intervention.
Conclusions
What Were We Thinking! is a postnatal mental health intervention which has the potential to contribute to psychologically-informed routine primary postnatal health care and prevent common mental disorders in women.
doi:10.1186/1471-2458-10-499
PMCID: PMC2931475  PMID: 20718991
25.  Maternally Administered Interventions for Preterm Infants in the NICU: Effects on Maternal Psychological Distress and Mother-Infant Relationship 
Infant behavior & development  2014;37(4):695-710.
Although studies have examined the effects of interventions focused on preterm infants, few studies have examined the effects on maternal distress (anxiety, depressive symptoms, post-traumatic stress symptoms, parenting stress) or parenting. This study examined the effects of the auditory-tactile-visual-vestibular (ATVV) intervention and kangaroo care (KC) on maternal distress and the mother-infant relationship compared to an attention control group.
240 mothers from four hospitals were randomly assigned to the three groups. Maternal characteristics in the three groups were similar: 64.1% of ATVV mothers, 64.2% of KC mothers, and 76.5% of control mothers were African American; maternal age averaged 26.3 years for ATVV mothers, 28.1 for KC mothers, and 26.6 for control mothers; and years of education averaged 13.6 for ATVV and KC mothers, and 13.1 for control mothers. Mothers only differed on parity: 68.4% of ATVV and 54.7% of KC mothers were first-time mothers as compared to 43.6% of control mothers. Their infants had a similar mean gestational ages (27.0 weeks for ATVV, 27.2 for KC, and 27.4 for control) and mean birthweights (993 grams for ATVV, 1022 for KC, and 1023 for control).
Mothers completed questionnaires during hospitalization, and at 2, 6 and 12 months corrected age on demographic characteristics, depressive symptoms, state anxiety, post-traumatic stress symptoms, parenting stress, worry about child health, and child vulnerability (only at 12 months). At 2 and 6 months, 45-minute videotapes of mother-infant interactions were made, and the HOME Inventory was scored. Behaviors coded from the videotapes and a HOME subscale were combined into five interactive dimensions: maternal positive involvement and developmental stimulation and child social behaviors, developmental maturity, and irritability.
Intervention effects were examined using general linear mixed models controlling for parity and recruitment site. The groups did not differ on any maternal distress variable. Kangaroo care mothers showed a more rapid decline in worry than the other mothers. The only interactive dimensions that differed between the groups were child social behaviors and developmental maturity, which were both higher for kangaroo care infants. Change over time in several individual infant behaviors was affected by the interventions. When mothers reported on the interventions they performed, regardless of group assignment, massage (any form including ATVV) was associated with a more rapid decline in depressive symptoms and higher HOME scores. Performing either intervention was associated with lower parenting stress. These findings suggest that as short-term interventions, KC and ATVV, have important effects on mothers and their preterm infants, especially in the first half of the first year.
doi:10.1016/j.infbeh.2014.08.005
PMCID: PMC4262690  PMID: 25247740
Preterm infants; auditory-tactile-visual-vestibular intervention; kangaroo care; infant massage; mother-infant interactions; maternal psychological distress

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