Attachment and Biobehavioral Catch-up and Depression Treatment

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Maternal Depression, Child Behavior Problem

Intervention / Treatment
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* Behavioral: Attachment and Biobehavioral Catch up
* Behavioral: Attachment and Biobehavioral Catch up Plus Depression Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) 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 English- or Spanish-speaking Exclusion Criteria: Self-reported history of psychosis or active suicidality as defined by self-report of a specific suicide plan or recent attempt Child diagnosis of autism

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ABC<br>Attachment and Biobehavioral Catch-up, 10 weekly sessions that provide parenting support | Behavioral: Attachment and Biobehavioral Catch up<br>* 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.<br>* Other names: ABC;|
| Experimental: ABC+D<br>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<br>* 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.<br>* Other names: ABC+D;|

What is the study measuring?
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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 |