The “NIH-DC Initiative to Reduce Infant Mortality in Minority Populations” is a collaboration between Children's National Medical Center, Georgetown University, George Washington University Medical Center, Howard University, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Center on Minority Health and Health Disparities and RTI International. As part of this collaboration, we conducted a RCT to evaluate the efficacy of an integrated behavioral intervention delivered during PNC in reducing cigarette smoking, environmental tobacco smoke exposure (ETSE), depression and IPV during pregnancy and in improving pregnancy outcome. This study was reviewed and approved by the institutional review boards of all participating institutions.
Women were screened at six community based PNC sites serving mainly minority women in the District of Columbia between July, 2001 and October, 2003. Women were demographically eligible if they self-identified as being a minority, were ≥18 years old, ≤28 weeks pregnant, a DC resident and English speaking. Almost two-thirds (63.4%) were recruited before 22 weeks gestation, 16.9% were recruited between 22 and 25 weeks gestation and 19.7% were recruited between 26 and 28 weeks gestation. The women who were demographically eligible were consented in a two-stage consent and enrollment process. After initial consent, participants were screened for the four risk factors (cigarette smoking, ETSE, depression, and IPV) using an audio-computer assisted self interview which also confirmed their demographic eligibility. An average of 9 days after screening, a baseline interview took place where more detailed information on socio-demographics, reproductive history and behavioral risks was collected. Following this interview, women were consented to participate. Follow-up data collection by telephone interviews occurred during the second and third trimesters of pregnancy (22-26 and 34-38 weeks gestation, respectively) and 8-10 weeks postpartum. Intervention and follow-up activities continued until July 2004. Details are published in El-Khorazaty et al.35
A total of 2,913 women were screened and 1,398 met eligibility criteria (See ). Of these 85% (n=1,191) consented to participate in a baseline telephone interview before randomization; 1,070 (89.9%) were reached and participated. Eligible women were randomized to the intervention group or usual care group. Of these women 1,044 were African-American and still pregnant at the time of the baseline interview. Included in the analyses were 521 randomized to the intervention and 523 randomized to usual care.
Profile of Project DC-HOPE Randomized Controlled Trial
Women randomized to the intervention received an integrated cognitive behavioral intervention and women randomized to usual care received their usual prenatal care, as determined by the standard procedures at the PNC clinic. 336 women reported IPV victimization in the past year during the baseline interview and this group could be further categorized as having minor and/or severe IPV, physical and/or sexual IPV based on the Conflict Tactics Scale (CTS).36
A woman may experience multiple types of violence; thus these categories are not mutually exclusive. Minor IPV was defined if the woman's partner slapped, grabbed, pushed, or shoved her, threw something at her, twisted her arm or hair, and insisted, without using force, on anal sex, intercourse, or sex without using a condom. Major IPV was defined if the woman's partner kicked, bit, punched, beat up, hit, choked or slammed her, used knife or gun, burned or scalded her on purpose, and used force or threats to have sex or anal sex. Physical IPV was defined if the woman's partner threw something at her, pushed or shoved her, used a knife or gun, hit, choked, slammed, grabbed, burned, or kicked her. Sexual assault was defined if the woman's partner forced sex without using a condom, forced her to have sex, threatened or insisted on having sex (oral, anal, or vaginal) against her will.
The intervention utilized in this RCT was delivered during routine PNC visits at the clinics by interventionists (master's level social workers or psychologists), trained specifically to deliver this intervention. The intervention was evidence-based and specific to each of the designated psycho-behavioral risks.37
At each intervention session the woman identified which of the four risks she was experiencing. The intervention was delivered by the interventionist and targeted to address all risks reported at each session, regardless of previously reported risks. The intervention for IPV emphasized safety behaviors and was based on the structured intervention developed by Parker and colleagues38
and based on Dutton's39
Empowerment Theory. This intervention provided information about the types of abuse (e.g., emotional, physical and sexual) and the cycle of violence (e.g., escalating, IPV, honeymoon period), a Danger Assessment Component to assess risks, and preventive options women might consider (e.g., filing a protection order) as well as the development of a safety plan (e.g., leaving important documents and papers with others). In addition, a list of community resources with addresses and phone numbers was provided. The intervention for smoking and ETSE were combined and based on Smoking Cessation or Reduction in Program Treatment. This intervention was cognitive-behavioral and based on a woman's stage of readiness for behavioral change.40
The depression intervention was developed by Miranda and Munoz 41
based on cognitive behavioral theory and focused on mood management, increasing pleasurable activities and increasing positive social interactions.
The components of the intervention were designed for delivery in a minimum of four sessions with eight prenatal sessions required for a complete intervention, based on the highest number of sessions required for a specific risk. Fifty-one percent of the women randomized to the intervention received four or more sessions, while one-quarter of the women attended no intervention sessions. Individualized counseling sessions provided an integrated approach to multiple risks responsive to a woman's specific risk combination. Two additional postpartum booster sessions were provided to reinforce risk-specific intervention goals and support women through the postpartum period. Intervention sessions were conducted privately in a room proximate to or within the PNC clinics and occurred immediately before or after routine PNC. Intervention activities addressing all of the individually identified risks at each session lasted for an average of 35+15 minutes. Women in the intervention received $10 for each intervention session and additional $15 and $25 gift certificates for the first and second postpartum intervention sessions, respectively.
During screening or follow-up, women reporting suicidal ideation were immediately referred to the mental health consultation team. Women were evaluated and referred, as necessary. Those found to be potentially suicidal (n=10) were excluded from the study.
The sample size was powered to test the reduction in psycho-behavioral risk, with the theory that a reduction in risk would help improve pregnancy outcomes. Assuming a 5% level of significance, 80% power would allow the detection of 10-20% reductions in risk-specific factors among women in the intervention from a prevalence of 100% at recruitment. A sample of 1,050 women needed to be retained at the end of the follow-up period (525 women in each of the intervention and usual care group). The anticipated number of women reporting IPV needed to detect significance in reducing risk was 337 split between the two care groups). This sample size was also sufficient to detect a 25% reduction in preterm birth and low birth weight combined in the intervention as compared to that for the usual care group (estimated at 20%). Based on a declining birth rate in D.C., the recruitment period was extended four months to reach the required sample size.
Site- and risk-specific permuted block randomization to the intervention or usual care was conducted. Both the investigators and the field workers were blinded to block size. A computer generated randomization scheme was utilized to consider all the possible risk combinations within each of the recruitment sites. When a woman completed the baseline interview and was ready for randomization, the recruitment staff would call the data coordinating center, where the subject's assignment was determined.
Validated instruments were used for each of the data collection time points. During screening, IPV was identified by the Abuse Assessment Screen, a measure designed and validated for use in pregnancy if a woman reported physical or sexual abuse by a partner in the previous year.42
During the baseline and follow-up interviews, the frequency of physical assault and sexual coercion (partner to self) was measured by the Conflict Tactics Scale.36
A more detailed description of instruments used for other risks is available in Katz et al.37
Telephone interviewers and their supervisors were blinded to the participants’ randomization group. Research staff maintained confidentiality when communicating with participants outside the clinic setting. Addresses were collected to facilitate tracing efforts, but the women were informed that they would not receive mail from Project DC-HOPE. For women experiencing IPV, staff did not want to raise women's risk for abuse by receiving mail from the study that might be negatively regarded by an abusive partner, or would expose her pregnancy. Women were also asked whether or not telephone messages from project staff could be left on their telephone answering machines. If not, this was noted in her computerized record accessible by all project teams. As financial incentives the women received $5 for the screening, a 30-minute telephone card for providing main study consent, and $15 for each telephone interview. At the time of recruitment medical records were abstracted and upon delivery data on infant and pregnancy outcomes were recorded.
To preserve the randomization, participant data were analyzed according to their care group assignment, regardless of receipt of intervention, using an intent-to-treat approach. All statistical analyses were conducting using SAS version 9.1.3 (SAS Institute, Cary, NC). Bivariate analyses were conducted to compare the baseline characteristics and pregnancy outcomes of women assigned to the intervention versus usual care and to compare women who reported a recurrence of IPV during pregnancy or postpartum versus those who did not. T-tests compared groups based on continuous variables (using the TTEST procedure in SAS) and chi-square tests compared the groups with respect to categorical variables (using SAS's FREQ procedure). Logistic regression was used to model recurrence of IPV based on care group assignment, controlling for relevant covariates (using the LOGISTIC procedure). Logistic models were also created to predict minor, severe, physical and sexual IPV reported at each interview. Adjusted odd ratios (AOR) were produced by models that included care group plus other covariates.