A Pilot Evaluation of the Pregnant Moms' Empowerment Program

Sponsor

University of Notre Dame (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05011825

Collaborator

University of Memphis (Other)

137

Enrollment

Locations

Arms

81.5

Anticipated Duration (Months)

68.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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,

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.

Condition or Disease	Intervention/Treatment	Phase
Violence Depression Posttraumatic Stress Disorder Parenting Infant Development Child Behavior	Behavioral: Pregnant Moms' Empowerment Program	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

137 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

A Pilot Evaluation of the Pregnant Moms' Empowerment Program

Actual Study Start Date :

Mar 15, 2017

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pregnant Moms' Empowerment Program The PMEP is a 5-session program, delivered prenatally. The first three sessions address violence and mental health and the final two sessions address labor/delivery, infant health and early parenting.	Behavioral: Pregnant Moms' Empowerment Program 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.
No Intervention: Control Control group participants received information about community resources, but did not receive any study-related intervention.

Arm

Intervention/Treatment

Experimental: Pregnant Moms' Empowerment Program

The PMEP is a 5-session program, delivered prenatally. The first three sessions address violence and mental health and the final two sessions address labor/delivery, infant health and early parenting.

Behavioral: Pregnant Moms' Empowerment Program

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.

No Intervention: Control

Control group participants received information about community resources, but did not receive any study-related intervention.

Outcome Measures

Primary Outcome Measures

Center for Epidemiological Studies Depression Scale [Change from baseline assessment to post-test (5-6 weeks later)]
Depression
Center for Epidemiological Studies Depression Scale [Change from baseline assessment to 3 months postpartum]
Depression
Center for Epidemiological Studies Depression Scale [Change from baseline assessment to 12 months postpartum]
Depression
Center for Epidemiological Studies Depression Scale [Change from baseline assessment to 3.5-5 years postpartum]
Depression
PTSD Checklist - 5 [Change from baseline assessment to post-test (5-6 weeks later)]
Posttraumatic Stress
PTSD Checklist - 5 [Change from baseline assessment to 3 months postpartum]
Posttraumatic Stress
PTSD Checklist - 5 [Change from baseline assessment to 12 months postpartum]
Posttraumatic Stress
PTSD Checklist - 5 [Change from baseline assessment to 3.5-5 years postpartum]
Posttraumatic Stress
Connors Davidson Resilience Scale [Change from baseline assessment to post-test (5-6 weeks later)]
Resilience
Connors Davidson Resilience Scale [Change from baseline assessment to 3 months postpartum]
Resilience
Connors Davidson Resilience Scale [Change from baseline assessment to 12 months postpartum]
Resilience
Connors Davidson Resilience Scale [Change from baseline assessment to 3.5-5 years postpartum]
Resilience
Conflict Tactics Scales - Revised [Change from baseline assessment to post-test (5-6 weeks later)]
Intimate Partner Violence
Conflict Tactics Scales - Revised [Change from baseline assessment to 3 months postpartum]
Intimate Partner Violence
Conflict Tactics Scales - Revised [Change from baseline assessment to 12 months postpartum]
Intimate Partner Violence
Conflict Tactics Scales - Revised [Change from baseline assessment to 3.5-5 years postpartum]
Intimate Partner Violence
Adult Adolescent Parenting Inventory [Change from baseline assessment to post-test (5-6 weeks later)]
Parenting Attitudes
Adult Adolescent Parenting Inventory [Change from baseline assessment to 3 months postpartum]
Parenting Attitudes
Adult Adolescent Parenting Inventory [Change from baseline assessment to 12 months postpartum]
Parenting Attitudes
Adult Adolescent Parenting Inventory [Change from baseline assessment to 3.5-5 years postpartum]
Parenting Attitudes
Karitane Parenting Inventory [Change from baseline assessment to post-test (5-6 weeks later)]
Parenting Confidence
Karitane Parenting Inventory [Change from baseline assessment to 3 months postpartum]
Parenting Confidence
Karitane Parenting Inventory [Change from baseline assessment to 12 months postpartum]
Parenting Confidence
Pregnancy Risk and Monitoring System (PRAMS) [Differences between groups at 3 months postpartum]
Labor, Delivery and Breastfeeding
Pregnancy Risk and Monitoring System (PRAMS) [Differences between groups at 12 months postpartum]
Labor, Delivery and Breastfeeding
Infant Development [Difference between groups at 12 months post partum]
Bayley Scales of Infant Development
Infant Development [Differences between groups at 3 months postpartum]
Bayley Scales of Infant Development
Infant Behavior Questionnaire [Differences between groups at 12 months post partum]
Infant Temperament
Maternal Sensitivity and Infant Affect Regulation [Differences between groups at 3 months postpartum]
Coded free play data
Maternal Sensitivity and Infant Affect Regulation [Differences between groups at 12 months postpartum]
Coded free play data

Secondary Outcome Measures

Lubben Social Network Scale [Change from baseline to posttest (5-6 weeks later)]
Social Support
Lubben Social Network Scale [Change from baseline to 3 months postpartum]
Social Support
Lubben Social Network Scale [Change from baseline to posttest 12 months postpartum]
Social Support
Lubben Social Network Scale [Change from baseline to posttest 3.5-5 years postpartum]
Social Support
Rotter Locus of Control Scale [Change from baseline to post-test (5-6 weeks later)]
Locus of Control
Rotter Locus of Control Scale [Change from baseline to 3 months postpartum]
Locus of Control
Rotter Locus of Control Scale [Change from baseline to 12 months postpartum]
Locus of Control
Child behavior checklist [3.5-5 years postpartum]
Child adjustment

Other Outcome Measures

Breastfeeding Behavior Scale [Differences between groups at 12 months post partum]
Breastfeeding attitudes
Postpartum Depression Scale [3 months postpartum]
Postpartum depression

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of NotreDame	Notre Dame	Indiana	United States	46556
2	University of Memphis	Memphis	Tennessee	United States	38152

Sponsors and Collaborators

University of Notre Dame
University of Memphis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Notre Dame

ClinicalTrials.gov Identifier:

NCT05011825

Other Study ID Numbers:

17-08-4035

First Posted:

Aug 18, 2021

Last Update Posted:

Aug 18, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Aug 18, 2021