Attachment and Biobehavioral Catch-up for Depression (ABC)

Attachment and Biobehavioral Catch-up for Depression Intervention

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.

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms; Anxiety Symptoms
• Intervention / Treatment: Behavioral: Attachment and Biobehavioral Catch-up (ABC) Intervention

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94107
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ABC; 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.

Behavioral: Attachment and Biobehavioral Catch-up (ABC) Intervention; ABC is a 10 session, home-based, dyadic therapy that is delivered by a trained professional. The sessions focus on improving the parent-child relationship and children's biological and behavioral responses to stress.; Other Names: ABC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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))	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 in score from baseline at post-intervention (week 10).
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))	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.	Change in score from baseline at post-intervention (week 10)

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Danielle Roubinov, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: A130886; K23MH113709 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No