Clinical trial NCT05011825: A Pilot Evaluation of the Pregnant Moms' Empowerment Program
Official title: A Pilot Evaluation of the Pregnant Moms' Empowerment Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Violence
Depression
Posttraumatic Stress Disorder
Parenting
Infant Development
Child Behavior
Lead sponsor: University of Notre Dame
Sponsor class: OTHER
Collaborators: name: University of Memphis
First posted: 2021-08-18
Enrollment: 137
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Center for Epidemiological Studies Depression Scale
timeFrame: Change from baseline assessment to post-test (5-6 weeks later)
measure: Center for Epidemiological Studies Depression Scale
timeFrame: Change from baseline assessment to 3 months postpartum
measure: Center for Epidemiological Studies Depression Scale
timeFrame: Change from baseline assessment to 12 months postpartum
measure: Center for Epidemiological Studies Depression Scale
timeFrame: Change from baseline assessment to 3.5-5 years postpartum
measure: PTSD Checklist - 5
timeFrame: Change from baseline assessment to post-test (5-6 weeks later)
measure: PTSD Checklist - 5
timeFrame: Change from baseline assessment to 3 months postpartum
measure: PTSD Checklist - 5
timeFrame: Change from baseline assessment to 12 months postpartum
measure: PTSD Checklist - 5
timeFrame: Change from baseline assessment to 3.5-5 years postpartum
measure: Connors Davidson Resilience Scale
timeFrame: Change from baseline assessment to post-test (5-6 weeks later)
measure: Connors Davidson Resilience Scale
timeFrame: Change from baseline assessment to 3 months postpartum
measure: Connors Davidson Resilience Scale
timeFrame: Change from baseline assessment to 12 months postpartum
measure: Connors Davidson Resilience Scale
timeFrame: Change from baseline assessment to 3.5-5 years postpartum
measure: Conflict Tactics Scales - Revised
timeFrame: Change from baseline assessment to post-test (5-6 weeks later)
measure: Conflict Tactics Scales - Revised
timeFrame: Change from baseline assessment to 3 months postpartum
measure: Conflict Tactics Scales - Revised
timeFrame: Change from baseline assessment to 12 months postpartum
measure: Conflict Tactics Scales - Revised
timeFrame: Change from baseline assessment to 3.5-5 years postpartum
measure: Adult Adolescent Parenting Inventory
timeFrame: Change from baseline assessment to post-test (5-6 weeks later)
measure: Adult Adolescent Parenting Inventory
timeFrame: Change from baseline assessment to 3 months postpartum
measure: Adult Adolescent Parenting Inventory
timeFrame: Change from baseline assessment to 12 months postpartum
measure: Adult Adolescent Parenting Inventory
timeFrame: Change from baseline assessment to 3.5-5 years postpartum
measure: Karitane Parenting Inventory
timeFrame: Change from baseline assessment to post-test (5-6 weeks later)
measure: Karitane Parenting Inventory
timeFrame: Change from baseline assessment to 3 months postpartum
measure: Karitane Parenting Inventory
timeFrame: Change from baseline assessment to 12 months postpartum
measure: Pregnancy Risk and Monitoring System (PRAMS)
timeFrame: Differences between groups at 3 months postpartum
measure: Pregnancy Risk and Monitoring System (PRAMS)
timeFrame: Differences between groups at 12 months postpartum
measure: Infant Development
timeFrame: Difference between groups at 12 months post partum
measure: Infant Development
timeFrame: Differences between groups at 3 months postpartum
measure: Infant Behavior Questionnaire
timeFrame: Differences between groups at 12 months post partum
measure: Maternal Sensitivity and Infant Affect Regulation
timeFrame: Differences between groups at 3 months postpartum
measure: Maternal Sensitivity and Infant Affect Regulation
timeFrame: Differences between groups at 12 months postpartum
Secondary outcomes:
measure: Lubben Social Network Scale
timeFrame: Change from baseline to posttest (5-6 weeks later)
measure: Lubben Social Network Scale
timeFrame: Change from baseline to 3 months postpartum
measure: Lubben Social Network Scale
timeFrame: Change from baseline to posttest 12 months postpartum
measure: Lubben Social Network Scale
timeFrame: Change from baseline to posttest 3.5-5 years postpartum
measure: Rotter Locus of Control Scale
timeFrame: Change from baseline to post-test (5-6 weeks later)
measure: Rotter Locus of Control Scale
timeFrame: Change from baseline to 3 months postpartum
measure: Rotter Locus of Control Scale
timeFrame: Change from baseline to 12 months postpartum
measure: Child behavior checklist
timeFrame: 3.5-5 years postpartum
Other outcomes:
measure: Breastfeeding Behavior Scale
timeFrame: Differences between groups at 12 months post partum
measure: Postpartum Depression Scale
timeFrame: 3 months postpartum
Locations:
city: Notre Dame
country: United States
facility: University of NotreDame
state: Indiana
city: Memphis
country: United States
facility: University of Memphis
state: Tennessee
Study officials:
References: