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Attachment and Biobehavioral Catch-up for Depression (ABC)

Primary Purpose

Depressive Symptoms, Anxiety Symptoms

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attachment and Biobehavioral Catch-up (ABC) Intervention
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABC

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Child Behavior Checklist Internalizing Scale score
T-scores range from 29 to 100 with higher values indicating more severe symptoms
Change in Center for Epidemiologic Studies Depression Scale score
Scores range from 0 to 60 with higher values indicating more severe symptoms

Secondary Outcome Measures

Full Information

First Posted
August 7, 2019
Last Updated
November 28, 2022
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04050202
Brief Title
Attachment and Biobehavioral Catch-up for Depression
Acronym
ABC
Official Title
Attachment and Biobehavioral Catch-up for Depression Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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: To evaluate the feasibility and acceptability of ABC for mothers with depressive symptoms and their offspring with internalizing symptoms To explore whether children who receive ABC show improvement in internalizing symptoms from pre- to post-intervention To explore whether mothers who receive ABC show improvement in depressive symptoms from pre- to post-intervention To explore whether parents and children who receive ABC show more adaptive physiological responses to stress from pre- to post-intervention

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Anxiety Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attachment and Biobehavioral Catch-up (ABC) Intervention
Other Intervention Name(s)
ABC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Child Behavior Checklist Internalizing Scale score
Description
T-scores range from 29 to 100 with higher values indicating more severe symptoms
Time Frame
Baseline to post-intervention, an anticipated average of 10 weeks
Title
Change in Center for Epidemiologic Studies Depression Scale score
Description
Scores range from 0 to 60 with higher values indicating more severe symptoms
Time Frame
Baseline to post-intervention, an anticipated average of 10 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Roubinov, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Attachment and Biobehavioral Catch-up for Depression

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