Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05011825 · ClinicalTrials.gov registry record · NA
A Pilot Evaluation of the Pregnant Moms' Empowerment Program
A NA study, sponsored by University of Notre Dame.
- Completed
- Registry status
- NA
- Development phase
- 137
- Enrollment target
NCT05011825: Completed NA study, sponsored by University of Notre Dame.
NCT05011825 is a NA study that has completed, run by University of Notre Dame. The registered enrollment target is 137 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05011825, a NA study, has completed, sponsored by University of Notre Dame.
- COMPLETED
- Registry status
- NA
- Development phase
- 137 participants
- Enrollment target
Study Summary
This project will use a longitudinal design with assessments at baseline (T1), post-treatment (T2), 3 month post-partum (T3), 1 year postpartum (T4) and 3.5-5 years postpartum to examine whether the PMEP improves participants': a) mental health (depression, PTSD) and resilience, b) parenting skills, c) birth, infant, and toddler developmental outcomes, and d) lowers re-victimization rates. We hypothesize significantly improved outcomes in the intervention group compared to the control group at post-treatment and at all follow-ups. The pilot will use a quasi-randomized design, with participants assigned to alternating treatment and control blocks. Analyses will be conducted using intent to treat and per protocol methods. Following group assignment, all women will be scheduled for a baseline interview at a time convenient for the participant. Participant interviews will take approximately 1.5 hours. Mothers will be compensated with a gift card in the amount of 40 USD for each interview. In addition to the core evaluation metrics, mothers' demographic information will be obtained (age, relationship status, employment, education, number of children, income). Following the baseline interview, the PMEP will be provided to the treatment group; participants will receive 2-hours of contact time per week for 5 weeks (2-hour sessions, held once weekly). Women will receive reminder calls the day of each session to identify and resolve any barriers to attendance (e.g., transportation). Taxi fare will be supported for women who are unable to obtain transportation if the bus is not feasible. Following the completion of the PMEP groups or - for the control group - after 5-6 weeks has passed, all participants will complete a second interview. This interview will include all of the core measures of hypothesized treatment change, thereby permitting a comparison between women in the treatment and control groups over time. All women will be invited in a third time when their infant is 3
Primary Outcome
Depression
Interventions
- BEHAVIORAL Pregnant Moms' Empowerment Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2017-03-15 |
| Est. Completion | 2021-02-15 |
| Phase | NA |
What the finished NCT05011825 record still lists
NCT05011825 is an interventional study that assigns participants to a tested intervention. The registered 137 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 (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Pregnant Moms' Empowerment Program is the first listed.
NCT05011825 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05011825 about?
NCT05011825 is a clinical study titled "A Pilot Evaluation of the Pregnant Moms' Empowerment Program". This project will use a longitudinal design with assessments at baseline (T1), post-treatment (T2), 3 month post-partum (T3), 1 year postpartum (T4) and 3.5-5 years postpartum to examine whether the PMEP improves participants': a) mental health (depression, PTSD) and resilience, b) parenting skills,...
What is the current status of trial NCT05011825?
This trial is currently completed. It is a NA study. The enrollment target is 137 participants. The study started on 2017-03-15. Estimated completion is 2021-02-15.
What interventions are being tested in trial NCT05011825?
The interventions under investigation include: Pregnant Moms' Empowerment Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT05011825?
This trial is sponsored by University of Notre Dame, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05011825's enrollment target sits among peer trials
137 722nd of 2000 higher than 1,279 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05091424 · 137 participants · Phase 1
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
- NCT05655182 · 137 participants · Phase 1
A Study of BLB-201 RSV Vaccine in Infants and Children
- NCT06571669 · 137 participants · NA
BOOM-IBD2 Pivotal Clinical Trial
- NCT06644768 · 137 participants · Phase 1
A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI