Skip to content

A Pilot Evaluation of the Pregnant Moms' Empowerment Program

A Pilot Evaluation of the Pregnant Moms' Empowerment Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05011825
Enrollment
137
Registered
2021-08-18
Start date
2017-03-15
Completion date
2021-02-15
Last updated
2023-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Behavior, Depression, Infant Development, Parenting, Posttraumatic Stress Disorder, Violence

Brief 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 months old and again when their infant is 1 year of age to evaluate parenting and infant outcomes. Women will participate in a brief phone assessment when their children are between 3.5 and 5 years of age that includes all primary study outcomes.

Interventions

The first session introduces women to the group, seeks to build an alliance and sense of group cohesion, and provides safety planning. The second session addresses intergenerational patterns of violence and how such violence contributes to psychopathology in both the prenatal and postnatal period, focusing on violence prevention. Information regarding cognitive restructuring, behavioral activation, and coping styles is provided in session three, as well as the role of healthy relationships and social supports in promoting resilience. This session begins with discussion on health in pregnancy, labor/delivery, and coordinating care across providers. This session also provides psychoeducation related to post-delivery parenting, including infant safety, care and breastfeeding. In the final session, group leaders assist mothers with identification, sensitivity, and responsiveness to infant cues.

Sponsors

University of Memphis
CollaboratorOTHER
University of Notre Dame
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* at least 16 years of age * experienced IPV in the past year * currently pregnant (\<33 weeks) * English speaking

Exclusion criteria

* insufficient fluency in English to participate in interviews/groups

Design outcomes

Primary

MeasureTime frameDescription
Maternal Sensitivity and Infant Affect RegulationDifferences between groups at 3 months postpartumCoded free play data
Adult Adolescent Parenting InventoryChange from baseline assessment to post-test (5-6 weeks later)Parenting Attitudes
Karitane Parenting InventoryChange from baseline assessment to post-test (5-6 weeks later)Parenting Confidence
Pregnancy Risk and Monitoring System (PRAMS)Differences between groups at 3 months postpartumLabor, Delivery and Breastfeeding
Infant DevelopmentDifference between groups at 12 months post partumBayley Scales of Infant Development
Infant Behavior QuestionnaireDifferences between groups at 12 months post partumInfant Temperament
Center for Epidemiological Studies Depression ScaleChange from baseline assessment to post-test (5-6 weeks later)Depression
PTSD Checklist - 5Change from baseline assessment to post-test (5-6 weeks later)Posttraumatic Stress
Connors Davidson Resilience ScaleChange from baseline assessment to post-test (5-6 weeks later)Resilience
Conflict Tactics Scales - RevisedChange from baseline assessment to post-test (5-6 weeks later)Intimate Partner Violence

Secondary

MeasureTime frameDescription
Lubben Social Network ScaleChange from baseline to posttest (5-6 weeks later)Social Support
Rotter Locus of Control ScaleChange from baseline to post-test (5-6 weeks later)Locus of Control
Child behavior checklist3.5-5 years postpartumChild adjustment

Other

MeasureTime frameDescription
Postpartum Depression Scale3 months postpartumPostpartum depression
Breastfeeding Behavior ScaleDifferences between groups at 12 months post partumBreastfeeding attitudes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026