Attachment and Biobehavioral Catch-up for Depression

NCT ID: NCT04050202

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-09-30

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

Conditions

Depressive Symptoms; Anxiety Symptoms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Attachment and Biobehavioral Catch-up (ABC) Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

ABC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle Roubinov, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K23MH113709

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A130886

Identifier Type: -

Identifier Source: org_study_id