African-American Social Support Effectiveness Treatment-Partners Alleviating Perinatal Depression
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Maternal Perinatal Depression
- Sponsor
- Northwestern University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Maternal depression
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Sheehan David Fisher
Associate Professor
Northwestern University
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
Outcomes
Primary Outcomes
Maternal depression
Time Frame: Second trimester through six month postpartum
The Inventory of Depressive Symptoms-Self-Rated (IDS-SR16) is a 16-item self-report measure of depressive symptoms. Minimum value: 0, Maximum value: 3, Higher scores indicate worse outcome
Maternal anxiety
Time Frame: Second trimester through six month postpartum
The Generalized Anxiety Disorder-7-item (GAD-7) is a 7-item, self-report measure assesses the dimension of generalized anxiety. Minimum value: 0, Maximum value: 3, Higher scores indicate worse outcome
Secondary Outcomes
- Infant affect and mood regulation(Administered at 1-, 3-, and 6-months)
- Breastfeeding(Administered at 1-, 3-, and 6-months)
- Parent-infant interaction quality(At 3- and 6-months)