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Pregnant Moms' Empowerment Program for Domestic Violence

N/A

Recruiting

Research Sponsored by University of Notre Dame

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

between 10-30 weeks pregnant

age 16 or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-months

Awards & highlights

Study Summary

This trial will test whether the Pregnant Moms' Empowerment Program is effective in improving maternal mental health, re-victimization rates, parenting sensitivity, and infant development compared to an active control group.

Who is the study for?

This trial is for English-speaking pregnant women, aged 16 or older, who are between 10-30 weeks into their pregnancy and have experienced intimate partner violence within the past year. Women must be willing to participate in all study components.Check my eligibility

What is being tested?

The trial tests the Pregnant Moms' Empowerment Program (PMEP) against a nondirective support group to see if PMEP improves maternal mental health, reduces re-victimization, enhances parenting sensitivity, and benefits infant development.See study design

What are the potential side effects?

There may not be direct physical side effects from participating in these programs; however, discussing sensitive topics like personal trauma could potentially lead to emotional discomfort or distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 10 and 30 weeks pregnant.

Select...

I am 16 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in depressed mood from baseline to 12-months postpartum

Change in depressed mood from baseline to 3-months postpartum

Change in depressed mood from baseline to posttreatment

+15 more

Secondary outcome measures

Change in empowerment from baseline to 12-months postpartum

Change in empowerment from baseline to 3-months postpartum

Change in empowerment from baseline to posttreatment

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pregnant Moms' Empowerment ProgramExperimental Treatment1 Intervention

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

Group II: Nondirective Support GroupActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pregnant Moms' Empowerment Program

2017

N/A

~140

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MemphisOTHER

70 Previous Clinical Trials

11,429 Total Patients Enrolled

1 Trials studying Infant Development

137 Patients Enrolled for Infant Development

University of Notre DameLead Sponsor

33 Previous Clinical Trials

61,134 Total Patients Enrolled

1 Trials studying Infant Development

137 Patients Enrolled for Infant Development

Media Library

Infant Development Clinical Trial 2023: Pregnant Moms' Empowerment Program Highlights & Side Effects. Trial Name: NCT04068662 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Might I be eligible to participate in this research project?

"This ongoing clinical trial is currently enrolling 460 participants between 3 months and 55 years of age."

Answered by AI

Does the eligibility criteria of this trial allow for people younger than 45?

"This trial requires that patients enrolled are between 3 Months and 55 years old. 126 studies for minors have been conducted, with an additional 434 studies being done on those over 65."

Answered by AI

Are new participants still being accepted for this research endeavor?

"Indeed, clinicaltrials.gov records demonstrate that this research is open to recruitment and was first posted on July 10th 2019. The latest update occurred on September 26th 2022 and the study requires 460 participants across two sites."

Answered by AI

What results are researchers expecting from this research endeavor?

"This clinical trial has multiple objectives to evaluate Maternal Sensitivity at 3 months post-treatment. Secondary outcomes include Change in empowerment, measured by the Personal Progress Scale Revised with scores ranging from 0 - 196; Change in social support, assessed using the Lubben Social Network Scale-Revised and scored between 0 - 90; and finally, change in empowerment again as evaluated by The Personal Progress Scale Revised which also ranges from 0 -196. We hypothesize that overall these measures of wellbeing will be higher for those receiving treatment than those partaking in the active control condition, additionally mediating relationships between mental health, revictimization resilience or sensitive"

Answered by AI

Are there any capacity limitations for enrolment in this trial?

"Confirmed. According to records found on clinicaltrials.gov, the trial which was initially posted in July of 2019 is actively seeking participants at 2 sites with a total goal of 460 enrollees."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intervention for IPV-exposed Pregnant Women

2019. "Intervention for IPV-exposed Pregnant Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04068662.

All > Domestic Violence > Ptsd