search
Back to results

African-American Social Support Effectiveness Treatment (ASSET-PPD)

Primary Purpose

Maternal Perinatal Depression

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD)
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Maternal Perinatal Depression focused on measuring perinatal depression, postpartum depression, anxiety, fathers, partners, parents, African American, social support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

  • Northwestern University, Feinberg School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ASSET-PPD intervention group

No additional treatment group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Maternal depression
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
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
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
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
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

Full Information

First Posted
February 27, 2023
Last Updated
May 31, 2023
Sponsor
Northwestern University
search

1. Study Identification

Unique Protocol Identification Number
NCT05762133
Brief Title
African-American Social Support Effectiveness Treatment
Acronym
ASSET-PPD
Official Title
African-American Social Support Effectiveness Treatment-Partners Alleviating Perinatal Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 27, 2020 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Perinatal Depression
Keywords
perinatal depression, postpartum depression, anxiety, fathers, partners, parents, African American, social support

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASSET-PPD intervention group
Arm Type
Experimental
Arm Description
25 parent dyads with a mother who is receiving individual treatment outside of the study and the father is receiving the ASSET-PPD training
Arm Title
No additional treatment group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maternal depression
Description
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
Time Frame
Second trimester through six month postpartum
Title
Maternal anxiety
Description
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
Time Frame
Second trimester through six month postpartum
Secondary Outcome Measure Information:
Title
Breastfeeding
Description
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
Time Frame
Administered at 1-, 3-, and 6-months
Title
Infant affect and mood regulation
Description
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
Time Frame
Administered at 1-, 3-, and 6-months
Title
Parent-infant interaction quality
Description
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
Time Frame
At 3- and 6-months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Eligibility for this study includes parent dyads of female-male co-parents.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Northwestern University, Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

African-American Social Support Effectiveness Treatment

We'll reach out to this number within 24 hrs