Attachment and Biobehavioral Catch-up and Depression Treatment (ABC+D)

March 30, 2026 updated by: University of California, San Francisco

Efficacy of an Integrated Intervention to Treat Maternal Depression and Children's Behavior Problems: A Transactional Perspective

Maternal depression influences the development of children's behavior problems and vice versa; however most interventions singularly address maternal depression or children's behavior problems rather than both. This project assesses the efficacy of an intervention that treats both mothers and children in an integrated manner. Effects are expected to disrupt the reciprocal relations that perpetuate maternal and child mental health problems over time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed project is a pilot randomized controlled trial to evaluate the effectiveness of an integrated intervention that dually treats maternal depressive symptoms and offspring behavior problems. Families (n = 40 mothers and their 2-to-4 year-old children) will be randomized to receive 10 sessions of ABC or 10 sessions of ABC+D in their home. ABC+D is an expanded version of ABC that additionally treats maternal depressive symptoms using Mothers and Babies adapted for mothers of toddlers. The specific aims of this proposed project are:

Aim 1. Collect preliminary data on the feasibility and acceptability of ABC+D in preparation for a small pilot randomized controlled trial (RCT).

Aim 2. Conduct a small pilot RCT to examine the effectiveness of ABC and ABC+D

Aim 3: Assess the overall acceptability (mother- and provider-rated), appropriateness (mother- and provider-rated), and feasibility (provider-rated) of ABC+D. Mothers will also rate their satisfaction with each session and the degree to which it was helpful, interesting, and comprehensible.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94118
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Mothers 18 years of age or older with heightened depressive symptoms as determined by a score of 5 or higher on the Patient Health Questionnaire-9 (PHQ-9)
  2. Biological children (of mothers described above) between 2 and 4 years old with heightened behavior problems as determined by a score of at least 3 in at least 1 domain of functioning on the Impairment Rating Scales
  3. English- or Spanish-speaking

Exclusion Criteria:

  1. Self-reported history of psychosis or active suicidality as defined by self-report of a specific suicide plan or recent attempt
  2. Child diagnosis of autism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ABC
Attachment and Biobehavioral Catch-up, 10 weekly sessions that provide parenting support
Behavioral: Attachment and Biobehavioral Catch up
ABC is delivered by a trained parent coach. The parent coach provides information about parenting and child development. The focus is on providing support for parents of young children and improving the parent-child relationship.
Other Names:
  • ABC
Experimental: ABC+D
Attachment and Biobehavioral Catch-up plus weekly 5-10 minute videos that additional provide support for mothers' mood, stress, and coping
Behavioral: Attachment and Biobehavioral Catch up Plus Depression Treatment
ABC+D offers the same 10-sessions of parenting support that is provided by ABC and additionally provides weekly short videos that help mothers develop skills for coping with stress and regulating mood.
Other Names:
  • ABC+D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score
Time Frame: Baseline to post-intervention. This is approximately 10 weeks.
Scores range from 34.5 to 82.3 with higher values indicating more severe symptoms
Baseline to post-intervention. This is approximately 10 weeks.
Change in Early Childhood Screening Assessment (ECSA) Score
Time Frame: Baseline to post-intervention. This is approximately 10 weeks.
Scores range from 0 to 80 with higher values indicating more severe symptoms
Baseline to post-intervention. This is approximately 10 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

October 30, 2024

Study Completion (Actual)

October 30, 2024

Study Registration Dates

First Submitted

October 25, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A137439
  • R56MH127032 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared via the NIMH Data Archive (NDA)

IPD Sharing Time Frame

Data from this clinical trial require significant processing after the completion of data collection. We will submit a clean dataset after the final data lock.

IPD Sharing Access Criteria

Researchers will the appropriate qualifications can request the dataset via the NIMH Data Archive Platform.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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