ASSET-PPD: African-American Social Support Effectiveness Treatment

Sponsor

Northwestern University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05762133

Collaborator

(none)

100

Enrollment

Location

Arms

32.1

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Maternal Perinatal Depression	Behavioral: African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD)	N/A

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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Single (Outcomes Assessor)

Masking Description:

At 3- and 6-months postpartum, mothers and fathers will attend an observation that includes a 5-minute free play with their infant separately and a 5-minute free play together as co-parents. Parent-infant interactions will be videotaped and interaction quality will be coded by a blind evaluator.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 27, 2020

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASSET-PPD intervention group 25 parent dyads with a mother who is receiving individual treatment outside of the study and the father is receiving the ASSET-PPD training	Behavioral: African-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 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.
No Intervention: No additional treatment group 25 parent dyads with a mother who is receiving individual treatment outside of the study and the father is not receiving the ASSET-PPD training

Arm

Intervention/Treatment

Experimental: ASSET-PPD intervention group

25 parent dyads with a mother who is receiving individual treatment outside of the study and the father is receiving the ASSET-PPD training

Behavioral: African-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 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.

No Intervention: No additional treatment group

25 parent dyads with a mother who is receiving individual treatment outside of the study and the father is not receiving the ASSET-PPD training

Outcome Measures

Primary Outcome Measures

Maternal depression [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 [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 Outcome Measures

Breastfeeding [Administered at 1-, 3-, and 6-months]
The FeedCat Tool (FT) is a 9-item self-report breastfeeding assessment that measures the type, amount, and mode of feeding. FT complies with the WHO and CDC recommendations
Infant affect and mood regulation [Administered at 1-, 3-, and 6-months]
The Infant Behavior Questionnaire- Revised (IBQ-R) is a 36-item parent-report measure of infant behaviors (positive/negative affect, regulation), Minimum value: 0, Maximum value: 7, Higher scores indicate greater level of temperament dimension of the 14 scales
Parent-infant interaction quality [At 3- and 6-months]
Mothers and fathers will attend an onsite observation that includes a 5-minute free play with their infant separately and a 5-minute free play together as co-parents. Parent-infant interactions will be videotaped by a split-screen Noldus Media Recorder. Interaction quality will be coded on the Parent-Child Early Relational Assessment (PCERA). PCERA is a valid, reliable measure of the quality of affect and behavior in parent-child interactions and has been used in psychiatric studies and triadic interactions. Minimum value: 1, Maximum value: 5, Higher scores indicate better outcomes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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