A Pilot Evaluation of the Pregnant Moms' Empowerment Program

Depression Clinical Trial

Official title:

A Pilot Evaluation of the Pregnant Moms' Empowerment Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05011825
• Other study ID #: 17-08-4035
• Status: Completed
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: February 15, 2021

Study information

• Verified date: November 2023
• Source: University of Notre Dame
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: February 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Behavior
• Depression
• Infant Development
• Parenting
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Violence

Intervention

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.

Locations

Country	Name	City	State
United States	University of Memphis	Memphis	Tennessee
United States	University of NotreDame	Notre Dame	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
University of Notre Dame	University of Memphis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Breastfeeding Behavior Scale	Breastfeeding attitudes	Differences between groups at 12 months post partum
Other	Postpartum Depression Scale	Postpartum depression	3 months postpartum
Primary	Center for Epidemiological Studies Depression Scale	Depression	Change from baseline assessment to post-test (5-6 weeks later)
Primary	Center for Epidemiological Studies Depression Scale	Depression	Change from baseline assessment to 3 months postpartum
Primary	Center for Epidemiological Studies Depression Scale	Depression	Change from baseline assessment to 12 months postpartum
Primary	Center for Epidemiological Studies Depression Scale	Depression	Change from baseline assessment to 3.5-5 years postpartum
Primary	PTSD Checklist - 5	Posttraumatic Stress	Change from baseline assessment to post-test (5-6 weeks later)
Primary	PTSD Checklist - 5	Posttraumatic Stress	Change from baseline assessment to 3 months postpartum
Primary	PTSD Checklist - 5	Posttraumatic Stress	Change from baseline assessment to 12 months postpartum
Primary	PTSD Checklist - 5	Posttraumatic Stress	Change from baseline assessment to 3.5-5 years postpartum
Primary	Connors Davidson Resilience Scale	Resilience	Change from baseline assessment to post-test (5-6 weeks later)
Primary	Connors Davidson Resilience Scale	Resilience	Change from baseline assessment to 3 months postpartum
Primary	Connors Davidson Resilience Scale	Resilience	Change from baseline assessment to 12 months postpartum
Primary	Connors Davidson Resilience Scale	Resilience	Change from baseline assessment to 3.5-5 years postpartum
Primary	Conflict Tactics Scales - Revised	Intimate Partner Violence	Change from baseline assessment to post-test (5-6 weeks later)
Primary	Conflict Tactics Scales - Revised	Intimate Partner Violence	Change from baseline assessment to 3 months postpartum
Primary	Conflict Tactics Scales - Revised	Intimate Partner Violence	Change from baseline assessment to 12 months postpartum
Primary	Conflict Tactics Scales - Revised	Intimate Partner Violence	Change from baseline assessment to 3.5-5 years postpartum
Primary	Adult Adolescent Parenting Inventory	Parenting Attitudes	Change from baseline assessment to post-test (5-6 weeks later)
Primary	Adult Adolescent Parenting Inventory	Parenting Attitudes	Change from baseline assessment to 3 months postpartum
Primary	Adult Adolescent Parenting Inventory	Parenting Attitudes	Change from baseline assessment to 12 months postpartum
Primary	Adult Adolescent Parenting Inventory	Parenting Attitudes	Change from baseline assessment to 3.5-5 years postpartum
Primary	Karitane Parenting Inventory	Parenting Confidence	Change from baseline assessment to post-test (5-6 weeks later)
Primary	Karitane Parenting Inventory	Parenting Confidence	Change from baseline assessment to 3 months postpartum
Primary	Karitane Parenting Inventory	Parenting Confidence	Change from baseline assessment to 12 months postpartum
Primary	Pregnancy Risk and Monitoring System (PRAMS)	Labor, Delivery and Breastfeeding	Differences between groups at 3 months postpartum
Primary	Pregnancy Risk and Monitoring System (PRAMS)	Labor, Delivery and Breastfeeding	Differences between groups at 12 months postpartum
Primary	Infant Development	Bayley Scales of Infant Development	Difference between groups at 12 months post partum
Primary	Infant Development	Bayley Scales of Infant Development	Differences between groups at 3 months postpartum
Primary	Infant Behavior Questionnaire	Infant Temperament	Differences between groups at 12 months post partum
Primary	Maternal Sensitivity and Infant Affect Regulation	Coded free play data	Differences between groups at 3 months postpartum
Primary	Maternal Sensitivity and Infant Affect Regulation	Coded free play data	Differences between groups at 12 months postpartum
Secondary	Lubben Social Network Scale	Social Support	Change from baseline to posttest (5-6 weeks later)
Secondary	Lubben Social Network Scale	Social Support	Change from baseline to 3 months postpartum
Secondary	Lubben Social Network Scale	Social Support	Change from baseline to posttest 12 months postpartum
Secondary	Lubben Social Network Scale	Social Support	Change from baseline to posttest 3.5-5 years postpartum
Secondary	Rotter Locus of Control Scale	Locus of Control	Change from baseline to post-test (5-6 weeks later)
Secondary	Rotter Locus of Control Scale	Locus of Control	Change from baseline to 3 months postpartum
Secondary	Rotter Locus of Control Scale	Locus of Control	Change from baseline to 12 months postpartum
Secondary	Child behavior checklist	Child adjustment	3.5-5 years postpartum