Clinical trial NCT05762133: African-American Social Support Effectiveness Treatment
Official title: African-American Social Support Effectiveness Treatment-Partners Alleviating Perinatal Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Perinatal Depression
Keywords: perinatal depression
postpartum depression
anxiety
fathers
partners
parents
African American
social support
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We plan to enroll 50 parent dyads (100 individuals total, 25 romantic or non-romantic partners per arm). If we assume 5% attrition at each phase, we anticipate analyzable data for between 20-25 parent duos per arm.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Parents will be 18 years of age or older.
* Parents are eligible for the study if the woman is in the 2nd trimester, she is receiving psychiatric treatment for depression with a score of 11 or greater on the Inventory of Depressive Symptoms-Self-Rated (IDS-SR16), which indicates clinically significant symptoms, and the mother is African-American
* Parents do not need to be romantic partners to be eligible. Infants (0-6 months) are included in the study to examine the parent-infant interactions

Exclusion Criteria:

The parents will be excluded if:

* There is report of ongoing physical or sexual abuse
* They have plans to terminate the pregnancy
* The woman is showing symptoms of hypomania/mania, psychosis, or substance use in the past 12 months

Father will be excluded if he:

* Has symptoms of psychosis in the past 12 months
* Has below 6th grade education
* Has difficulty focusing on 1 hour of instruction

Primary outcomes:
measure: Maternal depression
timeFrame: Second trimester through six month postpartum
measure: Maternal anxiety
timeFrame: Second trimester through six month postpartum
Secondary outcomes:
measure: Breastfeeding
timeFrame: Administered at 1-, 3-, and 6-months
measure: Infant affect and mood regulation
timeFrame: Administered at 1-, 3-, and 6-months
measure: Parent-infant interaction quality
timeFrame: At 3- and 6-months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University, Feinberg School of Medicine
state: Illinois
Study officials:
References: