Attachment and Biobehavioral Catch-up and Depression Treatment

Child Behavior Problem Clinical Trial

— ABC+D  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05096611
• Other study ID #: A137439
• Secondary ID: R56MH127032
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Behavior Problem
• Depression
• Depressive Disorder
• Maternal Depression
• Problem Behavior

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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