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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 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

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
~50 spots leftby Dec 2024