Attachment and Biobehavioral Catch-up and Depression Treatment

Not Applicable

Active, not recruiting

• Conditions: Maternal Depression; Child Behavior Problem
• Interventions: Behavioral: Attachment and Biobehavioral Catch up Plus Depression Treatment; Behavioral: Attachment and Biobehavioral Catch up

• Registration Number: NCT05096611
• Lead Sponsor: University of California, San Francisco

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-10-27
• Study Start: 2022-03-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 76

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABC+D	Attachment and Biobehavioral Catch up Plus Depression Treatment	Attachment and Biobehavioral Catch-up plus weekly 5-10 minute videos that additional provide support for mothers' mood, stress, and coping
ABC	Attachment and Biobehavioral Catch up	Attachment and Biobehavioral Catch-up, 10 weekly sessions that provide parenting support

Primary Outcome Measures

Name	Time	Method
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score	Baseline to post-intervention. This is an anticipated average of 10 weeks.	Scores range from 34.5 to 82.3 with higher values indicating more severe symptoms
Change in Early Childhood Screening Assessment score	Baseline to post-intervention. This is an anticipated average of 10 weeks.	Scores range from 0 to 72 with higher values indicating more severe symptoms

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States