Clinical Trials Directory

Trials / Completed

CompletedNCT05762133

African-American Social Support Effectiveness Treatment

African-American Social Support Effectiveness Treatment-Partners Alleviating Perinatal Depression

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Northwestern University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The objective of this treatment study is to develop and test an augmentation therapy in conjunction with maternal psychiatric treatment that targets the fathers' support of the mothers' mental health and contributions to the family environment to reduce maternal stress. The African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD) intervention will be delivered to fathers in an individual setting to target the context in which a mother lives to expand her support beyond the direct reach of her treatment professional. This study provides skills and training to fathers who have a partner with prenatal depression. The aim is to reduce maternal depression during the perinatal period and improve the family environment for the infant.

Detailed description

African-American (AA) mothers have a higher risk for perinatal depression than Caucasian women that is attributable to increased socio-environmental stressors. In addition, AA women have poor healthcare utilization and compliance with psychiatric treatment compared to Caucasian women. An intervention is required to supplement and support the clinical objectives of the mother's depression care without requiring the mother's direct involvement. Fathers are an underutilized resource to reduce the mother's environmental stress and encourage healthy maternal behaviors. The African-American Social Support Effectiveness Treatment- Partners alleviating Perinatal Depression (ASSET-PPD) protocol will target the fathers' support of the mothers' mental health treatment and their active engagement in the family to reduce maternal stress. The ASSET-PPD intervention will be designed to have 4 active modules that address key factors to reduce maternal stress during the prenatal period and 2 postpartum review sessions. The modules will be individual sessions constructed to provide training, information, and behavioral assignments to increase fathers': 1) prenatal and postpartum family involvement; 2) mental health psychoeducation; 3) interparental communication and relationship skills; and 4) balanced division of family tasks. ASSET-PPD will be evaluated in a pilot Randomized Clinical Trial (RCT) with 50 cohabitating or non-cohabitating fathers and AA mothers who will be randomized into the ASSET-PPD intervention or the comparator group. Fathers only will participate in the intervention, and mothers and fathers will complete measures of mental health and parental experiences. Maternal depressive symptoms will be assessed as a primary outcome, and breastfeeding and parent-infant interactions will be assessed as secondary outcomes.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAfrican-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD)This proposed novel intervention has four prenatal modules and two postpartum review sessions addressing key correlates of Perinatal Depression (PND) with the largest effect sizes by targeting fathers': 1) prenatal and postpartum family involvement; 2) mental health psychoeducation; 3) interparental communication and relationship skills; and 4) balanced division of family tasks. The intervention is based on the stress-generation and cognitive-behavior theories to frame skill-based individual sessions of didactics, interactive training, and trackable objectives.

Timeline

Start date
2020-08-27
Primary completion
2024-07-31
Completion
2024-07-31
First posted
2023-03-09
Last updated
2025-03-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05762133. Inclusion in this directory is not an endorsement.