Intervention for IPV-exposed Pregnant Women
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).
Conditions:
🦠 Postpartum Depression
🦠 Posttraumatic Stress Disorder
🦠 Infant Behavior
🦠 Violence
🦠 Parenting
🗓️ Study Start (Actual)
10 July 2019
🗓️ Primary Completion (Estimated)
20 December 2024
✅ Study Completion (Estimated)
20 December 2024
👥 Enrollment (Estimated)
460
🔬 Study Type
INTERVENTIONAL
📊 Phase
NA
Locations:
📍
Notre Dame, Indiana, United States
📍
Memphis, Tennessee, United States
Description
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
Exclusion Criteria:
- * fails to meet inclusion criteria
- * unavailable or unwilling to participate in core study components, including groups
Ages Eligible for Study:
3 Months to 55 Years (CHILD, ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
No
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported
results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before
being posted on the public website.
Study Registration Dates
- First Submitted
20 August 2019
- First Submitted that Met QC Criteria
22 August 2019
- First Posted
28 August 2019
Study Record Updates
- Last Update Submitted that Met QC Criteria
1 April 2024
- Last Update Posted
2 April 2024
- Last Verified
April 2024