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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: Completed NA study, sponsored by University of Notre Dame.

NCT04068662 is a NA study that has completed, run by University of Notre Dame. The registered enrollment target is 424 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Mothers will report on symptoms of posttraumatic stress using the PTSD Checklist for DSM-5 (Weathers, Litz, Keane, Palmieri, Marx, \& Schnurr, 2013). We hypothesize that compared to women in the active control condition, that beginning at the post-treatment assessment women in the treatment condition will have lower levels of posttraumatic stress. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a

Interventions

  • BEHAVIORAL Pregnant Moms' Empowerment Program
  • BEHAVIORAL Nondirective Support Group

Trial Details

FieldValue
Enrollment Target 424 participants
Start Date 2019-07-10
Est. Completion 2025-11-18
Phase NA
University of Notre Dame

13 total trials

What the finished NCT04068662 record still lists

NCT04068662 is an interventional study that assigns participants to a tested intervention. The registered 424 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 2 interventions - of which Pregnant Moms' Empowerment Program is the first listed.

NCT04068662 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04068662's enrollment target sits among peer trials

424 238th of 2000 higher than 1,763 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04068662, the US trial registry maintained by the National Library of Medicine. NCT04068662 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.