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NCT04068662 · ClinicalTrials.gov registry record · NA
Intervention for IPV-exposed Pregnant Women
A NA study, sponsored by University of Notre Dame.
- Completed
- Registry status
- NA
- Development phase
- 424
- Enrollment target
NCT04068662 is a NA study that has completed, run by University of Notre Dame. The registered enrollment target is 424 participants.
The verdict
NCT04068662, a NA study, has completed, sponsored by University of Notre Dame.
- COMPLETED
- Registry status
- NA
- Development phase
- 424 participants
- Enrollment target
Study 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
Interventions
- BEHAVIORAL Pregnant Moms' Empowerment Program
- BEHAVIORAL Nondirective Support Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 424 participants |
| Start Date | 2019-07-10 |
| Est. Completion | 2025-11-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04068662
The ClinicalTrials.gov registry entry for NCT04068662 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 424 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Notre Dame, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pregnant Moms' Empowerment Program is the first listed.
NCT04068662 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04068662 about?
NCT04068662 is a clinical study titled "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...
What is the current status of trial NCT04068662?
This trial is currently completed. It is a NA study. The enrollment target is 424 participants. The study started on 2019-07-10. Estimated completion is 2025-11-18.
What interventions are being tested in trial NCT04068662?
The interventions under investigation include: Pregnant Moms' Empowerment Program (BEHAVIORAL), Nondirective Support Group (BEHAVIORAL).
Who is sponsoring clinical trial NCT04068662?
This trial is sponsored by University of Notre Dame, which has 13 total clinical trials registered on ClinicalTrials.gov.
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