A Pilot Evaluation of the Pregnant Moms' Empowerment Program

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Evaluation of the Pregnant Moms' Empowerment Program

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

Intervention / Treatment
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* Behavioral: Pregnant Moms' Empowerment Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregnant Moms' Empowerment Program<br>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<br>* 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.<br>|
| No Intervention: Control<br>Control group participants received information about community resources, but did not receive any study-related intervention. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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