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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 is a NA study that has completed, run by University of Notre Dame. The registered enrollment target is 137 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05011825
The ClinicalTrials.gov registry entry for NCT05011825 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 137 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Notre Dame, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pregnant Moms' Empowerment Program is the first listed.
NCT05011825 reports 0 study locations.
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.
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