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

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: Recruiting
• Conditions: Child Behavior Problem; Maternal Depression
• Intervention / Treatment: Behavioral: Attachment and Biobehavioral Catch up; Behavioral: Attachment and Biobehavioral Catch up Plus Depression 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 (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danielle Roubinov, PhD; Phone Number: 415-476-2259; Email: danielle.roubinov@ucsf.edu

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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 Center for Epidemiologic Studies Depression Scale score	Scores range from 0 to 60 with higher values indicating more severe symptoms	Baseline to post-intervention, an anticipated average of 10 weeks
Change in Early Childhood Screening Assessment score	Scores range from 0 to 72 with higher values indicating more severe symptoms	Baseline to post-intervention, an anticipated average of 10 weeks

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Danielle Roubinov, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 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): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Problem Behavior
• Other Study ID Numbers: A137439

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