Attachment and Biobehavioral Catch-up for Depression

Not Applicable

Completed

• Conditions: Depressive Symptoms; Anxiety Symptoms
• Interventions: Behavioral: Attachment and Biobehavioral Catch-up (ABC) Intervention

• Registration Number: NCT04050202
• Lead Sponsor: University of California, San Francisco

Brief Summary

The overarching goal is to pilot the Attachment and Biobehavioral Catch-up (ABC) intervention for mothers with heightened depressive symptom and their children with heightened internalizing symptoms.

Detailed Description

Exposure to maternal depressive symptoms increases children's risk for developing anxiety and depressive symptoms ("internalizing symptoms"). Maternal depressive symptoms and children's internalizing symptoms may be reciprocally related over time. Optimal interventions for children's internalizing symptoms may involve treatment components for mothers, children, and the maternal-child relationship. The Attachment and Biobehavioral Catch-up (ABC) intervention is a empirically-supported, family-based treatment program that has been shown to be beneficial for children in varied high-risk family environments, but has yet to be tested among mothers and children recruited on the basis of heightened depressive and internalizing symptoms, respectively. The overarching goal is to examine the acceptability, feasibility, and preliminary effects of the ABC program on a sample of mother-child dyads (n = 20) with heightened depressive and internalizing symptoms. Our specific aims are:

1. To evaluate the feasibility and acceptability of ABC for mothers with depressive symptoms and their offspring with internalizing symptoms

2. To explore whether children who receive ABC show improvement in internalizing symptoms from pre- to post-intervention

3. To explore whether mothers who receive ABC show improvement in depressive symptoms from pre- to post-intervention

4. To explore whether parents and children who receive ABC show more adaptive physiological responses to stress from pre- to post-intervention

Study Timeline

• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-08
• Study Start: 2020-08-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Results First Submitted: 2023-12-18
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-18
• Last Update Submitted: 2024-07-18
• Results First Posted: 2024-07-22
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

1. Mothers between 18 and 50 years of age with heightened depressive symptoms as determined by a score of 16 or higher on the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R)
2. Biological children (of mothers described above) between 2 and 4 years old with heightened internalizing symptoms as determined by a T-score of 60 or higher on the Childhood Behavior Checklist (CBCL)

Read More

Exclusion Criteria

• Self-reported history of psychosis or active suicidality as defined by self-report of a specific suicide plan or recent attempt
• Current pregnancy
• Child diagnosis of autism
• Pacemaker implant, cardiac problems, cardiac medication

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABC	Attachment and Biobehavioral Catch-up (ABC) Intervention	ABC delivers therapy through 10, home-based, in-person sessions led by a trained professional. Treatment content is based on attachment theory and an understanding of children's stress neurobiology. Components aim to improve parental sensitivity, nurturance, and responsivity, as well as children's biological and behavioral reactivity through dyadic interactions between parents and children.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Internalizing Subscale Score of the Child Behavior Checklist (CBCL) at Week 10 (Value at Baseline Minus Value at Post Intervention (Week 10))	Change in score from baseline at post-intervention (week 10).	The internalizing subscale of the CBCL is a validated measure of emotional withdrawal, reactivity, sadness, anxiety, and other symptoms completed by mothers about their children. Scores range from 0 to 72 with higher scores indicating more severe symptoms.
Change From Baseline in Center for Epidemiologic Studies-Depression Scale (CES-D) at Week 10 (Value at Baseline Minus Value at Post Intervention (Week 10))	Change in score from baseline at post-intervention (week 10)	The CES-D is a validated self-report instrument of depressive symptoms. Scores range from 0 to 60 with higher values indicating more severe symptoms.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States