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Clinical Trials/NCT04050202
NCT04050202
Completed
Not Applicable

Attachment and Biobehavioral Catch-up for Depression Intervention

University of California, San Francisco1 site in 1 country42 target enrollmentAugust 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depressive Symptoms
Sponsor
University of California, San Francisco
Enrollment
42
Locations
1
Primary Endpoint
Change From Baseline in Internalizing Subscale Score of the Child Behavior Checklist (CBCL) at Week 10 (Value at Baseline Minus Value at Post Intervention (Week 10))
Status
Completed
Last Updated
last year

Overview

Brief Summary

The overarching goal is to pilot the Attachment and Biobehavioral Catch-up (ABC) intervention for mothers with heightened depressive symptom and their children with heightened internalizing symptoms.

Detailed Description

Exposure to maternal depressive symptoms increases children's risk for developing anxiety and depressive symptoms ("internalizing symptoms"). Maternal depressive symptoms and children's internalizing symptoms may be reciprocally related over time. Optimal interventions for children's internalizing symptoms may involve treatment components for mothers, children, and the maternal-child relationship. The Attachment and Biobehavioral Catch-up (ABC) intervention is a empirically-supported, family-based treatment program that has been shown to be beneficial for children in varied high-risk family environments, but has yet to be tested among mothers and children recruited on the basis of heightened depressive and internalizing symptoms, respectively. The overarching goal is to examine the acceptability, feasibility, and preliminary effects of the ABC program on a sample of mother-child dyads (n = 20) with heightened depressive and internalizing symptoms. Our specific aims are: 1. To evaluate the feasibility and acceptability of ABC for mothers with depressive symptoms and their offspring with internalizing symptoms 2. To explore whether children who receive ABC show improvement in internalizing symptoms from pre- to post-intervention 3. To explore whether mothers who receive ABC show improvement in depressive symptoms from pre- to post-intervention 4. To explore whether parents and children who receive ABC show more adaptive physiological responses to stress from pre- to post-intervention

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
September 30, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Mothers between 18 and 50 years of age with heightened depressive symptoms as determined by a score of 16 or higher on the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R)
  • Biological children (of mothers described above) between 2 and 4 years old with heightened internalizing symptoms as determined by a T-score of 60 or higher on the Childhood Behavior Checklist (CBCL)

Exclusion Criteria

  • Self-reported history of psychosis or active suicidality as defined by self-report of a specific suicide plan or recent attempt
  • Current pregnancy
  • Child diagnosis of autism
  • Pacemaker implant, cardiac problems, cardiac medication

Outcomes

Primary Outcomes

Change From Baseline in Internalizing Subscale Score of the Child Behavior Checklist (CBCL) at Week 10 (Value at Baseline Minus Value at Post Intervention (Week 10))

Time Frame: Change in score from baseline at post-intervention (week 10).

The internalizing subscale of the CBCL is a validated measure of emotional withdrawal, reactivity, sadness, anxiety, and other symptoms completed by mothers about their children. Scores range from 0 to 72 with higher scores indicating more severe symptoms.

Change From Baseline in Center for Epidemiologic Studies-Depression Scale (CES-D) at Week 10 (Value at Baseline Minus Value at Post Intervention (Week 10))

Time Frame: Change in score from baseline at post-intervention (week 10)

The CES-D is a validated self-report instrument of depressive symptoms. Scores range from 0 to 60 with higher values indicating more severe symptoms.

Study Sites (1)

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