Attachment and Biobehavioral Catch-up and Depression Treatment

University of California, San Francisco76 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Maternal Depression Child Behavior Problem

Interventions

Attachment and Biobehavioral Catch upBEHAVIORAL

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 TreatmentBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 2 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score

Scores range from 34.5 to 82.3 with higher values indicating more severe symptoms

Time frame: Baseline to post-intervention. This is approximately 10 weeks.

Change in Early Childhood Screening Assessment (ECSA) Score

Scores range from 0 to 80 with higher values indicating more severe symptoms

Time frame: Baseline to post-intervention. This is approximately 10 weeks.

Data from ClinicalTrials.gov

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