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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
Must not have
unavailable or unwilling to participate in core study components, including groups
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-months
Awards & highlights

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.
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.
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
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I am between 10 and 30 weeks pregnant.
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I am 16 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable or unwilling to participate in all parts of the study.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
71 Previous Clinical Trials
11,471 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
~21 spots leftby Dec 2024
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