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ABC: Attachment and Biobehavioral Catch-up for Depression

Sponsor
University of California, San Francisco (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04050202
Collaborator
(none)
42
Enrollment
1
Location
1
Arm
41
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Attachment and Biobehavioral Catch-up (ABC) Intervention
 N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Attachment and Biobehavioral Catch-up for Depression Intervention
Actual Study Start Date :
Aug 1, 2019
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ABC

ABC delivers therapy through 10, home-based, in-person sessions led by a trained professional. Treatment content is based on attachment theory and an understanding of children's stress neurobiology. Components aim to improve parental sensitivity, nurturance, and responsivity, as well as children's biological and behavioral reactivity through dyadic interactions between parents and children.

Behavioral: Attachment and Biobehavioral Catch-up (ABC) Intervention
ABC is a 10 session, home-based, dyadic therapy that is delivered by a trained professional. The sessions focus on improving the parent-child relationship and children's biological and behavioral responses to stress.
Other Names:
  • ABC

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Child Behavior Checklist Internalizing Scale score [Baseline to post-intervention, an anticipated average of 10 weeks]

      T-scores range from 29 to 100 with higher values indicating more severe symptoms

    2. Change in Center for Epidemiologic Studies Depression Scale score [Baseline to post-intervention, an anticipated average of 10 weeks]

      Scores range from 0 to 60 with higher values indicating more severe symptoms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. 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)

    2. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco San Francisco California United States 94107

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    • Principal Investigator: Danielle Roubinov, PhD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT04050202
    Other Study ID Numbers:
    • A130886
    First Posted:
    Aug 8, 2019
    Last Update Posted:
    Oct 14, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Depression

    Study Results

    No Results Posted as of Oct 14, 2021