Program to support pregnant women exposed to intimate partner violence
Intervening During the Prenatal Period With Women Exposed to Intimate Partner Violence to Improve Maternal Functioning and Infant Adjustment
NA · University of Notre Dame · NCT04068662
This study is testing a program designed to help pregnant women who have experienced intimate partner violence improve their mental health and parenting skills while also supporting their baby's development.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 460 (estimated) |
| Ages | 3 Months to 55 Years |
| Sex | Female |
| Sponsor | University of Notre Dame (other) |
| Locations | 2 sites (Notre Dame, Indiana and 1 other locations) |
| Trial ID | NCT04068662 on ClinicalTrials.gov |
What this trial studies
This project evaluates the Pregnant Moms' Empowerment Program (PMEP) through a randomized clinical trial aimed at improving maternal mental health, reducing re-victimization, enhancing parenting sensitivity, and promoting infant development among pregnant women who have experienced intimate partner violence (IPV). Participants will be randomly assigned to either the PMEP or a contact-equivalent control group and will undergo assessments at various stages of their pregnancy and postpartum. The study will take place at the University of Notre Dame and the University of Memphis, with a total of 230 women recruited from the local communities over approximately 2.5 years.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 16 or older who have experienced intimate partner violence within the past year and are between 10 and 30 weeks pregnant.
Not a fit: Patients who do not meet the inclusion criteria or are unwilling to participate in the study components may not receive any benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve the mental health and parenting outcomes for mothers exposed to IPV, benefiting both them and their infants.
How similar studies have performed: Other studies have shown promising results with similar interventions aimed at supporting women exposed to IPV, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * currently pregnant (primi or multiparous) * experienced intimate partner violence within the past year * English speaking * age 16 or older * between 10-30 weeks pregnant Exclusion Criteria: * fails to meet inclusion criteria * unavailable or unwilling to participate in core study components, including groups
Where this trial is running
Notre Dame, Indiana and 1 other locations
- University of Notre Dame — Notre Dame, Indiana, United States (RECRUITING)
- University of Memphis — Memphis, Tennessee, United States (RECRUITING)
Study contacts
- Study coordinator: Laura Miller-Graff
- Email: lmiller8@nd.edu
- Phone: 574-631-3245
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postpartum Depression, Posttraumatic Stress Disorder, Infant Behavior, Violence, Parenting, intimate partner violence, resilience, psychological