Intervention for IPV-exposed Pregnant Women

NCT ID: NCT04068662

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 424 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-10
• Study Completion Date: 2025-11-18

Brief Summary

The overarching goal of the proposed project is to evaluate a randomized clinical trial of the Pregnant Moms' Empowerment Program aimed at detecting its effects on maternal mental health, re-victimization, parenting sensitivity, and infant development. The project also seeks to examine theoretically-grounded mechanisms of change, including social support and empowerment. Women participating in the study will receive either the PMEP or participate in a contact-equivalent active control group during pregnancy, and will be interviewed at baseline, post-intervention and with their infants at 3 months and 1 year old. The study will occur at two sites - the University of Notre Dame and the University of Memphis. Participants will be recruited from the local community at both locations, with an equal number of women drawn from each site - Memphis, Tennessee (n=115) and South Bend, Indiana (n=115). Enrollment will continue for approximately 2.5 years, with an expected rate of 8 eligible women per month, based on a pilot study of the Pregnant Moms' Empowerment Program. The expected duration of the study for each participant will be approximately 1.5 years, with some variation due to women enrolling at different points in their pregnancy.

The primary objective of the proposed project is to determine if the Pregnant Moms' Empowerment Program has positive effects on maternal mental health, re-victimization rates, parenting sensitivity, and infant development compared to women's participation in a contact-equivalent active control group. This objective will be evaluated using a multi-site randomized clinical trial design. Participants (N = 230) will be equally randomized into study arms. Eligible women will include those who are: 1) currently pregnant (primi or multiparous) and between 10 and 30 weeks gestation, 2) experienced IPV within the past year, 3) English speaking and 4) age 16 or older.

The study will include 9 total visits: 4 assessments and 5 sessions for both study arms. In-person assessment visits will be completed by a trained research assistant; each visit will take approximately 2-3 hours, with post-partum assessments somewhat longer than prenatal assessments given the addition of the infant developmental assessment and parent-child observation task. Women will be compensated $30 for the first two assessments and $50 for the second two assessments. Following the final assessment, women will be invited to complete a daily diary (virtually) each day for 30 days. Each survey will take approximately 5-10 minutes to complete, and women will be compensated $2 for each completed survey. Women will also receive a $10 bonus for each set of 10 consecutive surveys. Treatment sessions will be 2 hours in duration. Women in the PMEP will complete a structured set of sessions: (1) supporting each other, support in the community, (2) identifying and understanding sources of distress, (3) cognitive and behavioral strategies to build resilience and resolve conflict, (4) perinatal health and infant care, and (5) positive parenting. Women in the active control condition will participate in facilitated discussions on a topic identified by the group. All sessions will be audio recorded so that treatment fidelity can be evaluated (for the Pregnant Moms' Empowerment Program) and so that content overlap can be assessed (for the active control condition).

Detailed Description

The study will occur at two sites - the University of Notre Dame and the University of Memphis. Participants will be recruited from the local community at both locations, with an equal number of women drawn from each site (n=115 at each site for a total of N=230 mothers). Enrollment will continue for approximately 2.5 years, with an expected rate of 8 eligible women per month, based on a pilot study of the PMEP. The expected duration of the study for each participant is approximately 1.75 years, with some variation due to women enrolling at different points in their pregnancy. The primary objective of the current study is to determine if the PMEP has positive effects on maternal mental health, re-victimization rates, parenting sensitivity, and infant development, as compared to women's participation in a contact-equivalent control group. This objective will be evaluated usin ga multi-site randomized clinical trial design. Participants (N=230) will be equally randomized into study arms. Eligible women include those who are currently pregnant, who have experienced IPV in the past year, are age 16 or older, and are currently between 10 and 30 weeks pregnant. In-person assessment visits will be completed by a trained research assistant; each visit will take approximately 2-3 hours, with postpartum assessments somewhat longer than prenatal assessments due to the addition of the infant developmental assessment. Women will be compensated $30 for the first two assessments and $50 for the second two assessments. Treatment sessions will be 2 hrs in duration. Women in the PMEP will complete a structured set of sessions: (1) safety planning, (2) identifying and understanding sources of distress, (3) cognitive and behavioral strategies to build resilience and resolve conflict, (4) perinatal health and infant care, (5) positive parenting. Women in the AC will participate in facilitated discussions on a topic identified by the group. All sessions will be audiorecorded so that treatment fidelity can be evaluated (for PMEP) and content overlap can be identified (for AC).

Conditions

Postpartum Depression; Posttraumatic Stress Disorder; Infant Behavior; Violence; Parenting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pregnant Moms' Empowerment Program

Five session group therapy program covering safety planning, resilience and coping, infant care and parenting.

Group Type: EXPERIMENTAL

Pregnant Moms' Empowerment Program

Intervention Type: BEHAVIORAL

The Pregnant Moms' Empowerment Program is a five session group therapy program designed for pregnant women with a recent history of exposure to intimate partner violence. One session is administered each week with a duration of 2 hours each, for a total of ten contact hours across the course of the intervention. Intervention topics includes safety planning, social support, resilience, psychoeducation about intimate partner violence, cognitive and behavioral strategies for remediating distress, infant sleep and breastfeeding, responsive parenting, and co-parenting.

Nondirective Support Group

Five session nondirective support group with two co-leaders who assist in facilitating open discussion on women's self-identified discussion topics.

Group Type: ACTIVE_COMPARATOR

Nondirective Support Group

Intervention Type: BEHAVIORAL

Participants in the non-directive support group condition participate in groups of the same size and with the same total contact time as women in Intervention 1. In contrast to the structured, manualized content delivered as a part of the Pregnant Moms' Empowerment Program, however, group leaders in this condition facilitate open conversation on topics that women identify together as a group.

Interventions

Pregnant Moms' Empowerment Program

The Pregnant Moms' Empowerment Program is a five session group therapy program designed for pregnant women with a recent history of exposure to intimate partner violence. One session is administered each week with a duration of 2 hours each, for a total of ten contact hours across the course of the intervention. Intervention topics includes safety planning, social support, resilience, psychoeducation about intimate partner violence, cognitive and behavioral strategies for remediating distress, infant sleep and breastfeeding, responsive parenting, and co-parenting.

Intervention Type: BEHAVIORAL

Nondirective Support Group

Participants in the non-directive support group condition participate in groups of the same size and with the same total contact time as women in Intervention 1. In contrast to the structured, manualized content delivered as a part of the Pregnant Moms' Empowerment Program, however, group leaders in this condition facilitate open conversation on topics that women identify together as a group.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• currently pregnant (primi or multiparous)
• experienced intimate partner violence within the past year
• English speaking
• age 16 or older
• between 10-30 weeks pregnant

• unavailable or unwilling to participate in core study components, including groups

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Memphis

OTHER

Sponsor Role: collaborator

University of Notre Dame

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Notre Dame

Notre Dame, Indiana, United States

University of Memphis

Memphis, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

19-03-5260

Identifier Type: -

Identifier Source: org_study_id