A Pilot Evaluation of the Pregnant Moms' Empowerment Program
Primary Purpose
Violence, Depression, Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pregnant Moms' Empowerment Program
Sponsored by
About this trial
This is an interventional treatment trial for Violence
Eligibility Criteria
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
Sites / Locations
- University of NotreDame
- University of Memphis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pregnant Moms' Empowerment Program
Control
Arm Description
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.
Control group participants received information about community resources, but did not receive any study-related intervention.
Outcomes
Primary Outcome Measures
Center for Epidemiological Studies Depression Scale
Depression
Center for Epidemiological Studies Depression Scale
Depression
Center for Epidemiological Studies Depression Scale
Depression
Center for Epidemiological Studies Depression Scale
Depression
PTSD Checklist - 5
Posttraumatic Stress
PTSD Checklist - 5
Posttraumatic Stress
PTSD Checklist - 5
Posttraumatic Stress
PTSD Checklist - 5
Posttraumatic Stress
Connors Davidson Resilience Scale
Resilience
Connors Davidson Resilience Scale
Resilience
Connors Davidson Resilience Scale
Resilience
Connors Davidson Resilience Scale
Resilience
Conflict Tactics Scales - Revised
Intimate Partner Violence
Conflict Tactics Scales - Revised
Intimate Partner Violence
Conflict Tactics Scales - Revised
Intimate Partner Violence
Conflict Tactics Scales - Revised
Intimate Partner Violence
Adult Adolescent Parenting Inventory
Parenting Attitudes
Adult Adolescent Parenting Inventory
Parenting Attitudes
Adult Adolescent Parenting Inventory
Parenting Attitudes
Adult Adolescent Parenting Inventory
Parenting Attitudes
Karitane Parenting Inventory
Parenting Confidence
Karitane Parenting Inventory
Parenting Confidence
Karitane Parenting Inventory
Parenting Confidence
Pregnancy Risk and Monitoring System (PRAMS)
Labor, Delivery and Breastfeeding
Pregnancy Risk and Monitoring System (PRAMS)
Labor, Delivery and Breastfeeding
Infant Development
Bayley Scales of Infant Development
Infant Development
Bayley Scales of Infant Development
Infant Behavior Questionnaire
Infant Temperament
Maternal Sensitivity and Infant Affect Regulation
Coded free play data
Maternal Sensitivity and Infant Affect Regulation
Coded free play data
Secondary Outcome Measures
Lubben Social Network Scale
Social Support
Lubben Social Network Scale
Social Support
Lubben Social Network Scale
Social Support
Lubben Social Network Scale
Social Support
Rotter Locus of Control Scale
Locus of Control
Rotter Locus of Control Scale
Locus of Control
Rotter Locus of Control Scale
Locus of Control
Child behavior checklist
Child adjustment
Full Information
NCT ID
NCT05011825
First Posted
August 2, 2021
Last Updated
September 26, 2022
Sponsor
University of Notre Dame
Collaborators
University of Memphis
1. Study Identification
Unique Protocol Identification Number
NCT05011825
Brief Title
A Pilot Evaluation of the Pregnant Moms' Empowerment Program
Official Title
A Pilot Evaluation of the Pregnant Moms' Empowerment Program
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
February 15, 2021 (Actual)
Study Completion Date
February 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Notre Dame
Collaborators
University of Memphis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Violence, Depression, Posttraumatic Stress Disorder, Parenting, Infant Development, Child Behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pregnant Moms' Empowerment Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group participants received information about community resources, but did not receive any study-related intervention.
Intervention Type
Behavioral
Intervention Name(s)
Pregnant Moms' Empowerment Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Center for Epidemiological Studies Depression Scale
Description
Depression
Time Frame
Change from baseline assessment to post-test (5-6 weeks later)
Title
Center for Epidemiological Studies Depression Scale
Description
Depression
Time Frame
Change from baseline assessment to 3 months postpartum
Title
Center for Epidemiological Studies Depression Scale
Description
Depression
Time Frame
Change from baseline assessment to 12 months postpartum
Title
Center for Epidemiological Studies Depression Scale
Description
Depression
Time Frame
Change from baseline assessment to 3.5-5 years postpartum
Title
PTSD Checklist - 5
Description
Posttraumatic Stress
Time Frame
Change from baseline assessment to post-test (5-6 weeks later)
Title
PTSD Checklist - 5
Description
Posttraumatic Stress
Time Frame
Change from baseline assessment to 3 months postpartum
Title
PTSD Checklist - 5
Description
Posttraumatic Stress
Time Frame
Change from baseline assessment to 12 months postpartum
Title
PTSD Checklist - 5
Description
Posttraumatic Stress
Time Frame
Change from baseline assessment to 3.5-5 years postpartum
Title
Connors Davidson Resilience Scale
Description
Resilience
Time Frame
Change from baseline assessment to post-test (5-6 weeks later)
Title
Connors Davidson Resilience Scale
Description
Resilience
Time Frame
Change from baseline assessment to 3 months postpartum
Title
Connors Davidson Resilience Scale
Description
Resilience
Time Frame
Change from baseline assessment to 12 months postpartum
Title
Connors Davidson Resilience Scale
Description
Resilience
Time Frame
Change from baseline assessment to 3.5-5 years postpartum
Title
Conflict Tactics Scales - Revised
Description
Intimate Partner Violence
Time Frame
Change from baseline assessment to post-test (5-6 weeks later)
Title
Conflict Tactics Scales - Revised
Description
Intimate Partner Violence
Time Frame
Change from baseline assessment to 3 months postpartum
Title
Conflict Tactics Scales - Revised
Description
Intimate Partner Violence
Time Frame
Change from baseline assessment to 12 months postpartum
Title
Conflict Tactics Scales - Revised
Description
Intimate Partner Violence
Time Frame
Change from baseline assessment to 3.5-5 years postpartum
Title
Adult Adolescent Parenting Inventory
Description
Parenting Attitudes
Time Frame
Change from baseline assessment to post-test (5-6 weeks later)
Title
Adult Adolescent Parenting Inventory
Description
Parenting Attitudes
Time Frame
Change from baseline assessment to 3 months postpartum
Title
Adult Adolescent Parenting Inventory
Description
Parenting Attitudes
Time Frame
Change from baseline assessment to 12 months postpartum
Title
Adult Adolescent Parenting Inventory
Description
Parenting Attitudes
Time Frame
Change from baseline assessment to 3.5-5 years postpartum
Title
Karitane Parenting Inventory
Description
Parenting Confidence
Time Frame
Change from baseline assessment to post-test (5-6 weeks later)
Title
Karitane Parenting Inventory
Description
Parenting Confidence
Time Frame
Change from baseline assessment to 3 months postpartum
Title
Karitane Parenting Inventory
Description
Parenting Confidence
Time Frame
Change from baseline assessment to 12 months postpartum
Title
Pregnancy Risk and Monitoring System (PRAMS)
Description
Labor, Delivery and Breastfeeding
Time Frame
Differences between groups at 3 months postpartum
Title
Pregnancy Risk and Monitoring System (PRAMS)
Description
Labor, Delivery and Breastfeeding
Time Frame
Differences between groups at 12 months postpartum
Title
Infant Development
Description
Bayley Scales of Infant Development
Time Frame
Difference between groups at 12 months post partum
Title
Infant Development
Description
Bayley Scales of Infant Development
Time Frame
Differences between groups at 3 months postpartum
Title
Infant Behavior Questionnaire
Description
Infant Temperament
Time Frame
Differences between groups at 12 months post partum
Title
Maternal Sensitivity and Infant Affect Regulation
Description
Coded free play data
Time Frame
Differences between groups at 3 months postpartum
Title
Maternal Sensitivity and Infant Affect Regulation
Description
Coded free play data
Time Frame
Differences between groups at 12 months postpartum
Secondary Outcome Measure Information:
Title
Lubben Social Network Scale
Description
Social Support
Time Frame
Change from baseline to posttest (5-6 weeks later)
Title
Lubben Social Network Scale
Description
Social Support
Time Frame
Change from baseline to 3 months postpartum
Title
Lubben Social Network Scale
Description
Social Support
Time Frame
Change from baseline to posttest 12 months postpartum
Title
Lubben Social Network Scale
Description
Social Support
Time Frame
Change from baseline to posttest 3.5-5 years postpartum
Title
Rotter Locus of Control Scale
Description
Locus of Control
Time Frame
Change from baseline to post-test (5-6 weeks later)
Title
Rotter Locus of Control Scale
Description
Locus of Control
Time Frame
Change from baseline to 3 months postpartum
Title
Rotter Locus of Control Scale
Description
Locus of Control
Time Frame
Change from baseline to 12 months postpartum
Title
Child behavior checklist
Description
Child adjustment
Time Frame
3.5-5 years postpartum
Other Pre-specified Outcome Measures:
Title
Breastfeeding Behavior Scale
Description
Breastfeeding attitudes
Time Frame
Differences between groups at 12 months post partum
Title
Postpartum Depression Scale
Description
Postpartum depression
Time Frame
3 months postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of NotreDame
City
Notre Dame
State/Province
Indiana
ZIP/Postal Code
46556
Country
United States
Facility Name
University of Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38152
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Pilot Evaluation of the Pregnant Moms' Empowerment Program
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