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Objective

Infants who cry a lot, or are unsettled in the night, are common sources of concern for parents and costly problems for health services. The two types of problems have been linked together and attributed to a general disturbance of infant regulation. Yet the infant behaviours involved present differently, at separate ages and times of day. To clarify causation, this study aims to assess whether prolonged crying at 5–6 weeks (the peak age for crying) predicts which infants are unsettled in the night at 12 weeks of age (when most infants become settled at night).

Methods

Data from two longitudinal studies are analysed. Infant crying data were obtained from validated behaviour diaries; sleep-waking data from standard parental questionnaires.

Results

A significant, weak relationship was found between crying at 5–6 weeks and 12-week night waking and signalling in one study, but not the other. Most infants who met the definition for prolonged crying/colic at 5–6 weeks were settled during the night at 12 weeks of age; they were not more likely than other infants to be unsettled.

Conclusions

Most infants who cry a lot at 5–6 weeks of age ‘sleep through the night’ at 12 weeks of age. This adds to evidence that the two types of problematic behaviour have different causes, and that infant sleep-waking problems usually involve maintenance of signalling behaviours rather than a generalised disturbance.

In the pediatric literature, excessive crying has been reported solely in association with 3-month colic and is described, if at all, as unexplained crying and fussing during the first 3 months of life. The bouts of crying are generally thought to be triggered by abdominal colic (over-inflation of the still immature gastrointestinal tract), and treatment is prescribed accordingly. According to this line of reasoning, excessive crying is harmless and resolves by the end of the third month without long-term consequences. However, there is evidence that it may cause tremendous distress in the mother-infant relationship, and can lead to disorders of behavioral and emotional regulation at the toddler stage (such as sleep and feeding disorders, chronic fussiness, excessive clinginess, and temper tantrums). Early treatment of excessive crying focuses on parent-infant communication, and parent-infant interaction in the context of soothing and settling the infant to sleep is a promising approach that may prevent later behavioral and emotional disorders in infancy.

Objective

To compare the effect of a behavioural sleep intervention with written information about normal sleep on infant sleep problems and maternal depression.

Design

Randomised controlled trial.

Setting

Well child clinics, Melbourne, Australia

Participants

156 mothers of infants aged 6-12 months with severe sleep problems according to the parents.

Main outcome measures

Maternal report of infant sleep problem; scores on Edinburgh postnatal depression scale at two and four months.

Intervention

Discussion on behavioural infant sleep intervention (controlled crying) delivered over three consultations.

Results

At two months more sleep problems had resolved in the intervention group than in the control group (53/76 v 36/76, P=0.005). Overall depression scores fell further in the intervention group than in the control group (mean change −3.7, 95% confidence interval −4.7 to −2.7, v −2.5, −1.7 to −3.4, P=0.06). For the subgroup of mothers with depression scores of 10 and over more sleep problems had resolved in the intervention group than in the control group (26/33 v 13/33, P=0.001). In this subgroup depression scores also fell further for intervention mothers than control mothers at two months (−6.0, −7.5 to −4.0, v −3.7, −4.9 to −2.6, P=0.01) and at four months (−6.5, −7.9 to 5.1 v –4.2, –5.9 to −2.5, P=0.04). By four months, changes in sleep problems and depression scores were similar.

Conclusions

Behavioural intervention significantly reduces infant sleep problems at two but not four months. Maternal report of symptoms of depression decreased significantly at two months, and this was sustained at four months for mothers with high depression scores.

What is already known on this topicInfant sleep problems and postnatal depression are both common potentially serious problemsWomen whose infants have sleep problems are more likely to report symptoms of depressionUncontrolled studies in clinical populations suggest that reducing infant sleep problems improves postnatal depression, but there is no good quality evidence in the community for such effectivenessWhat this study addsA brief community based sleep intervention based on teaching the controlled crying method effectively decreased infant sleep problems and symptoms of maternal depression, particularly for “depressed” mothersThe intervention was acceptable to mothers and reduced the need for other sources of help

AIMS—To estimate the financial cost to the NHS of infant crying and sleeping problems in the first 12 weeks of age and to assess the cost effectiveness of behavioural and educational interventions aimed at reducing infant crying and sleeping problems relative to usual services.
METHODS—A cost burden analysis and cost effectiveness analysis were conducted using data from the Crying Or Sleeping Infants (COSI) Study, a three armed prospective randomised controlled trial that randomly allocated 610 mothers to a behavioural intervention (n = 205), an educational intervention (n = 202), or existing services (control, n = 203). Main outcome measures were annual total cost to the NHS of infant crying and sleeping problems in the first 12 weeks, and incremental cost per interruption free night gained for behavioural and educational interventions relative to control.
RESULTS—The annual total cost to the NHS of infant crying and sleeping problems in the first 12 weeks was £65 million (US$104 million). Incremental costs per interruption free night gained for the behavioural intervention relative to control were £0.56 (US$0.92). For the educational intervention relative to control they were £4.13 (US$6.80).
CONCLUSIONS—The annual total cost to the NHS of infant crying and sleeping problems is substantial. In the cost effectiveness analysis, the behavioural intervention incurred a small additional cost and produced a small significant benefit at 11 and 12 weeks of age. The educational intervention incurred a small additional cost without producing a significant benefit.



Sleep-wake behaviors and temperament were examined longitudinally for trait stability and relationship to behavioral state regulation from infancy to early childhood. Subjects were 120 low-risk, full-term infants from a middle class sample. At 6 weeks, parents completed 3 consecutive days of the Baby’s Day Diary which measures sleep, wake, fuss, feed and cry states and the Infant Characteristics Questionnaire. At 16 months, parents assessed sleep behaviors with the Sleep Habits Inventory and temperament with the Toddler Symptom Checklist. At 24 months, parents repeated 3 days of the Baby’s Day Diary. Structural Equation Modeling was used to examine cross-age hypotheses for sleep-wake and temperament associations. From early infancy to toddlerhood, sleep-wake behaviors and irritable temperament were notably stable but independent in this cohort.

Background: Settling and night waking problems are particularly prevalent, persistent, and generally considered difficult to treat in children with a learning disability, although intervention trials are few. Scarce resources, however, limit access to proven behavioural treatments.

Aims: To investigate the efficacy of a media based brief behavioural treatment of sleep problems in such children by comparing (1) face-to-face delivered treatment versus control and (2) booklet delivered treatment versus controls.

Methods: The parents of 66 severely learning disabled children aged 2–8 years with settling and/or night waking problems took part in a randomised controlled trial with a wait-list control group. Behavioural treatments were presented either conventionally face-to-face or by means of a 14 page easy to read illustrated booklet. A composite sleep disturbance score was derived from sleep diaries kept by parents.

Results: Both forms of treatment were almost equally effective compared with controls. Two thirds of children who were taking over 30 minutes to settle five or more times per week and waking at night for over 30 minutes four or more times per week improved on average to having such settling or night waking problems for only a few minutes or only once or twice per week (H = 34.174, df = 2, p<0.001). These improvements were maintained after six months.

Conclusions: Booklet delivered behavioural treatments for sleep problems were as effective as face-to-face treatment for most children in this population.

Chronic sleep disturbance, such as bed refusal, sleep-onset delay, and night waking with crying, affects 15% to 35% of preschool children. Biological factors, particularly arousals associated with recurrent episodes of rapid-eye-movement sleep, render infants vulnerable to repeated awakenings. Parental failure to establish appropriate stimulus control of sleep-related behaviors and parent-mediated contingencies of reinforcement for sleep-incompatible behaviors may shape and maintain infant sleep disturbance. Treatment and prevention strategies are discussed, and research needs are identified.

Origins of mothers’ and fathers’ beliefs about infant crying were examined in 87 couples. Parents completed measures of emotion minimization in the family of origin, depressive symptoms, empathy, trait anger, and coping styles prenatally. At 6 months postpartum, parents completed a self-report measure of their beliefs about infant crying. Mothers endorsed more infant-oriented and less parent-oriented beliefs about crying than did fathers. Consistent with prediction, a history of emotion minimization was linked with more parent-oriented and fewer infant-oriented beliefs about infant crying for both mothers and fathers either as a main effect or in conjunction with the partners’ infant-oriented beliefs. Contrary to expectation, parents’ own emotional dispositions had little effect on parents’ beliefs about crying. The pattern of associations varied for mothers and fathers in a number of ways. Implications for future research and programs promoting sensitive parenting are discussed.

Objective To test a transactional model of sleep–wake development in infants born preterm or low birthweight (PT LBW), which may inform clinical practice, interventions, and future research in this at risk population. Methods One hundred and twenty-eight mother–infant dyads participated from hospital discharge to 4 months postterm. Assessments of prematurity, infant sleep–wake patterns, maternal interaction quality, depression, feeding route, and sociodemographic factors were conducted. Results Path analyses revealed that maternal interactions directly related to infant sleep patterns and family sociodemographic risks related to less optimal parenting. In addition, bottle fed infants experienced fewer night wakings and more nighttime sleep. Conclusions Two potential pathways to sleep patterns in PT LBW infants were identified. The findings suggest directions for clinical work, such as supporting healthy infant sleep through parenting interventions or supporting interpersonal relations between parents and their PT LBW infants by encouraging more daytime naps. Additionally, clinicians should assess parents’ nighttime sleep concerns within the larger sociodemographic and feeding context.

Objectives

To assess the efficacy of treatments for settling problems and night waking in young children.

Design

A systematic review of randomised controlled trials of interventions for settling problems and night waking in young children.

Setting

Electronic bibliographic databases and references on identified papers, hand searches, and personal contact with specialists.

Subjects

Children aged 5 years or less who had established settling problems or night waking.

Interventions

Interventions had to be described and a placebo, waiting list, or another intervention needed to have been used as a comparison. Interventions comprised drug trials or non-drug trials.

Main outcome measures

Number of wakes at night, time to settle, or number of nights in which these problems occurred.

Results

Drugs seemed to be effective in treating night waking in the short term, but long term efficacy was questionable. In contrast, specific behavioural interventions showed both short term efficacy and possible longer term effects for dealing with settling problems and night waking.

Conclusions

Given the prevalence and persistence of childhood sleep problems and the effects they can have on children and families, treatments that offer long lasting benefits are appealing and these are likely to be behavioural interventions.

OBJECTIVE:

Examine the prevalence, patterns, and persistence of parent-reported sleep problems during the first 3 years of life.

METHODS:

Three hundred fifty-nine mother/child pairs participated in a prospective birth cohort study. Sleep questionnaires were administered to mothers when children were 6, 12, 24, and 36 months old. Sleep variables included parent response to a nonspecific query about the presence/absence of a sleep problem and 8 specific sleep outcome domains: sleep onset latency, sleep maintenance, 24-hour sleep duration, daytime sleep/naps, sleep location, restlessness/vocalization, nightmares/night terrors, and snoring.

RESULTS:

Prevalence of a parent-reported sleep problem was 10% at all assessment intervals. Night wakings and shorter sleep duration were associated with a parent-reported sleep problem during infancy and early toddlerhood (6–24 months), whereas nightmares and restless sleep emerged as associations with report of a sleep problem in later developmental periods (24–36 months). Prolonged sleep latency was associated with parent report of a sleep problem throughout the study period. In contrast, napping, sleep location, and snoring were not associated with parent-reported sleep problems. Twenty-one percent of children with sleep problems in infancy (compared with 6% of those without) had sleep problems in the third year of life.

CONCLUSIONS:

Ten percent of children are reported to have a sleep problem at any given point during early childhood, and these problems persist in a significant minority of children throughout early development. Parent response to a single-item nonspecific sleep query may overlook relevant sleep behaviors and symptoms associated with clinical morbidity.

Introduction:

Few convincing treatment options have been identified for the excessively crying infant. One explanation may be a lack of identification of patient subgroups. This study used a clinically plausible categorization protocol to subgroup infants and compared changes in symptoms between these subgroups during treatment.

Methods:

An observational cohort design was employed. All infants presenting with excessive infant crying between July 2007 and March 2008 were categorized into three subgroups, (A) infant colic, (B) irritable infant syndrome of musculoskeletal origin (IISMO) and (C) inefficient feeding crying infants with disordered sleep (IFCIDS) based on history and physical findings. Mothers completed questionnaires which rated their own and their child’s characteristics prior to and at the end, of a course of manual therapy. Independent associations between infant subgroups and changes in continuous outcomes (crying, stress, sleep, and consolability) were assessed. Multivariable analysis of covariance was used to identify and control for potential confounders.

Results:

A total of 158 infants were enrolled. There was no significant difference in demographic profile between groups or any significant difference in infant crying or level of maternal stress at the start. Only the putative subgroups were significantly associated with differences in outcomes. In general, colic babies improved the most in consolability and crying.

Conclusion:

Babies with excessive crying should not be viewed as a homogenous group. Treatment outcomes may be improved by targeting appropriate subgroups prior to treatment.

Objective To assess the efficacy of treatment of settling problems and night waking in young children. Design A systematic review of randomized controlled trials of interventions. Setting Electronic bibliographic databases and references on identified papers, hand searches, and personal contact with specialists. Subjects Children aged 5 years or younger who had established settling problems or night waking.Interventions Interventions had to be described and a placebo, waiting list, or another intervention needed to have been used as a comparison.Interventions comprised drug trials or non drug trials. Main outcome measures Number of wakes at night, time to settle, or number of nights in which these problems occurred. Results Drugs seemed to be effective in treating night waking in the short term, but long-term efficacy was questionable. In contrast, specific behavioral interventions showed both short-term efficacy and possible longer term effects for dealing with settling problems and night walking. Conclusions Given the prevalence and persistence of childhood sleep problems and the effects they can have no children and families, treatments that offer long-lasting benefits are more appealing, and these are likely to be behavioral interventions.

We evaluated the effectiveness of SleepTight in the management of infant colic. SleepTight is a device that vibrates the infant's crib to simulate the action of a car traveling at 55 mph. A multiple baseline design across 6 infants was used. Data were collected on infant crying, parental use of SleepTight, and parental satisfaction. The application of SleepTight was associated with reduction in crying in 4 of the 6 infants. These outcome data notwithstanding, consideration of reported nonrecording of severe episodes and mixed reports of satisfaction suggests that SleepTight may not be a viable means of managing infant colic.

Purpose of review

Sleep–wake problems such as night wakings, excessive crying, or difficulties in falling asleep are frequent behavioral issues during childhood. Maturational changes in sleep and circadian regulation likely contribute to the development and maintenance of such problems. This review highlights the recent research examining bioregulatory sleep mechanisms during development and provides a model for predicting sleep–wake behavior in young humans.

Recent findings

Findings demonstrate that circadian and sleep homeostatic processes exhibit maturational changes during the first two decades of life. The developing interaction of both processes may be a key determinant of sleep–wake and crying behavior in infancy. Evidence shows that the dynamics of sleep homeostatic processes slow down in the course of childhood (i.e., sleep pressure accumulates more slowly with increasing age) enabling children to be awake for consolidated periods during the day. Another current topic is the adolescent sleep phase delay, which appears to be driven primarily by maturational changes in sleep homeostatic and circadian processes.

Summary

The two-process model of sleep regulation is a valuable framework for understanding and predicting sleep–wake behavior in young humans. Such knowledge is important for improving anticipatory guidance, parental education, and patient care, as well as for developing appropriate social policies.

Objective

To assess whether embedding pediatric anticipatory guidance into books read to babies is an effective way to educate low-income, first-time mothers about injury prevention and health promotion practices.

Patients and Methods

Primiparous women (n = 168) were randomly assigned to one of three groups; an educational book group, a non-educational book group, or a no book group. Knowledge of anticipatory guidance topics from birth to 12 months of age (e.g., injury prevention, parenting, nutrition) was assessed during the third trimester of pregnancy and again when infants were approximately 2, 4, 6, 9, 12, and 18 months of age.

Results

The educational book group scored consistently higher on knowledge than the other two groups. The educational book group was found to have significantly higher knowledge scores than both the non-educational book group (ES = .3, p-value < 0.001) and the no book group (ES = .3, p-value < 0.001) in the longitudinal model.

Discussion

Books read by mothers to babies appear to be an effective way to provide anticipatory guidance to new mothers. However, future work is needed to determine if increased knowledge translates into safer and more developmentally appropriate parenting practices.

Background

Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour) from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT) aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups) and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy.

Methods/Design

This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group.

Discussion

The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups promotes healthy eating, physical activity and reduced sedentary behaviours. If proven to be effective, INFANT may protect children from the development of obesity and its associated social and economic costs.

Trial registration

Current Controlled Trials ISRCTN81847050

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).

Objective

To examine the psychological well-being of mothers following participation in a behavioural modification programme previously shown to improve infant sleep.

Design, setting and participants

A 45 min consultation with either a general practitioner (GP) or trained nurse providing verbal and written information describing sleep physiology in infants and strategies to improve infant sleep. Eighty mothers of infants 6−12 months of age with established infant sleep problems at a single general practice, Adelaide, South Australia.

Main outcome measures

The Depression Anxiety Stress Scale 21 (DASS21) immediately prior to the first consultation and again at follow-up approximately 3 weeks later. The number of infant nocturnal awakenings requiring parental support was also reported by mothers on both occasions.

Results

All measures of maternal well-being and infant nocturnal awakenings improved significantly. The mean number of maximum nocturnal awakenings decreased from 5.0 to 0.5 (mean difference 4.4, 95% CI 3.4 to 5.5). All measures of DASS21 improved significantly. The mean total DASS21 decreased from 29.1 to 14.9 (mean decrease 14.2, 95% CI 10.2 to 18.2); mean depression decreased from 7.9 to 2.8 (mean difference 5.2, 95% CI 3.7 to 6.7); mean anxiety decreased from 4.6 to 2.6 (mean difference 2.0, 95% CI 0.7 to 3.2); mean stress decreased from 16.6 to 9.5 (mean difference 7.0, 95% CI 5.1 to 9.0). The proportion of mothers assessed as having any degree of depression decreased by 85% from 26/80 (32.5%) to 4/80 (5%).

Conclusions

The number of nocturnal awakenings requiring parental support among infants aged 6−12 months significantly decreased following a single consultation on infant sleep physiology and teaching behavioural strategies to improve sleep. Significant improvements in maternal stress, anxiety and depression were also observed.

Aims: To examine the relation between colic and feeding difficulties and their impact on parental functioning for a primarily clinic referred sample.

Methods: Forty three infants (and their mothers) were enrolled between 6 and 8 weeks of age. Infants were divided into two groups, colic (n = 19) and comparison (n = 24), based on a modified Wessel rule of three criteria for colic. Families were assessed at two visits; one occurred in the laboratory and one occurred in a paediatric radiology office. Outcome measures included the clinical assessment of infant oral motor skills, behavioural observation of mother-infant feeding interactions, maternal questionnaires on infant crying, sleeping and feeding behaviours, and the occurrence of gastro-oesophageal reflux (GOR) in the infants using abdominal ultrasound.

Results: Infants in the colic group displayed more difficulties with feeding; including disorganised feeding behaviours, less rhythmic nutritive and non-nutritive sucking, more discomfort following feedings, and lower responsiveness during feeding interactions. Infants in the colic group also had more evidence of GOR based on the number of reflux episodes on abdominal ultrasound as well as maternal report of reflux. Mothers in the colic group reported higher levels of parenting stress.

Conclusions: Results provide the first systematic evidence of feeding problems in a subgroup of infants with colic. Data also illustrate the impact of these difficulties on parental and infant functioning. The association between feeding difficulties and colic suggests the potential for ongoing regulatory problems in infants presenting with clinically significant colic symptoms.

The association between asthma and sleep disturbances was assessed as part of a community survey of sleep patterns in children aged 4-48 months. A questionnaire covering the area of past and present sleep and settling behaviour, as well as health history and demographic data, was administered to 752 mothers of children visiting 14 well baby clinics. Fifty one (6.8%) of the children who were diagnosed as having asthma by their paediatricians were compared with the remaining healthy controls (children with perinatal problems, other chronic illnesses, developmental problems, or repeat admissions to hospital were excluded). Thirty nine per cent of the children with asthma and 38% of the normal controls were identified as regular wakers. The number of interrupted nights each week, settling time, and sleep duration were comparable. In the children with asthma an uninterrupted night's sleep was acquired later than in the control group. Parental perception of the severity of the sleep problem was similar in the two groups, as were the calming techniques. It is concluded that this study does not support a significantly increased prevalence of sleep disturbances among young children with asthma compared with their healthy peers.

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

Objective.

In an attempt to foster self-soothing during the night, a novel sleep aid infused with maternal odor was introduced to 4 groups of infants ranging in age from 3 to 12 months. Infants’ use of parent-provided sleep aids also was examined.

Methodology.

Nighttime sleep and waking behaviors were videotaped for 2 consecutive nights on 3 occasions over a 3-month interval. Using all-night video recording, the study examined the infant’s use of a novel sleep aid and parent-provided sleep aids during sleep onset and after nighttime awakenings.

Results.

Results indicated that infants of different ages differed in the types of sleep aids used when falling asleep either at the beginning of the night or after awakenings in the middle of the night. More 3-month-olds used their thumbs/fingers/hands, whereas more 6-month-olds used soft objects. The 6-month-olds were most likely to use the novel sleep aid. Almost all of the infants at all 4 ages used some type of object during the night. Intra-individual analyses showed that infants tended to change their pattern of sleep aid use over the 3-month study period.

Conclusions.

The data provide evidence that infants during the first year of life use sleep aids frequently and interchangeably rather than a specific favorite object.

Parents commonly seek clinicians' help for infant crying that they judge to be excessive. To date there is no independent evidence whether such babies actually cry more than average. To assess this, maternal diary and 24 hour audiotape recordings of the crying periods of 16 infants referred for excessive crying were compared with equivalent measures of a normative sample. The overall amounts of crying measured by the two methods were similar. The referred infants cried substantially more over 24 hours and in the afternoon and evening. The difference approached significance in the morning but was insignificant at night time. Some qualifications to the findings are indicated.

Background

Up to 70% of children with Attention-Deficit/Hyperactivity Disorder (ADHD) experience sleep problems including difficulties initiating and maintaining sleep. Sleep problems in children with ADHD can result in poorer child functioning, impacting on school attendance, daily functioning and behaviour, as well as parental mental health and work attendance. The Sleeping Sound with ADHD trial aims to investigate the efficacy of a behavioural sleep program in treating sleep problems experienced by children with ADHD. We have demonstrated the feasibility and the acceptability of this treatment program in a pilot study.

Methods/Design

This randomised controlled trial (RCT) is being conducted with 198 children (aged between 5 to 12 years) with ADHD and moderate to severe sleep problems. Children are recruited from public and private paediatric practices across the state of Victoria, Australia. Upon receiving informed written consent, families are randomised to receive either the behavioural sleep intervention or usual care. The intervention consists of two individual, face-to-face consultations and a follow-up phone call with a trained clinician (trainee consultant paediatrician or psychologist), focusing on the assessment and management of child sleep problems. The primary outcome is parent- and teacher-reported ADHD symptoms (ADHD Rating Scale IV). Secondary outcomes are child sleep (actigraphy and parent report), behaviour, daily functioning, school attendance and working memory, as well as parent mental health and work attendance. We are also assessing the impact of children's psychiatric comorbidity (measured using a structured diagnostic interview) on treatment outcome.

Discussion

To our knowledge, this is the first RCT of a behavioural intervention aiming to treat sleep problems in children with ADHD. If effective, this program will provide a feasible non-pharmacological and acceptable intervention improving child sleep and ADHD symptoms in this patient group.

Trial Registration

Current Controlled Trials ISRCTN68819261.

ISRCTN: ISRCTN68819261