Attachment and Biobehavioral Catch-up for Depression

NCT04050202 | Completed Results

• 2 other identifiers: A130886K23MH113709
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Anxiety Symptoms

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

ABC

EXPERIMENTAL

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

Interventions

Attachment and Biobehavioral Catch-up (ABC) Intervention BEHAVIORAL

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.

Also known as: ABC

ABC

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

abacavir; Methods

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and Caveats

Onset of the COVID-19 pandemic during the middle of the study. Some families completed the intervention in person and other families completed it virtually or a mix of in-person and virtual visits.

Results Point of Contact

• Title: Danielle Roubinov, PhD
• Organization: University of California, San Francisco

danielle.roubinov@ucsf.edu

919-843-5898

Study Officials

• Danielle Roubinov, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 8, 2019
• Study Start: August 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: July 22, 2024
• Results First Posted: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)