Attachment and Biobehavioral Catch-up for Depression

Depressive Symptoms Clinical Trial

— ABC  

Official title:

Attachment and Biobehavioral Catch-up for Depression Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04050202
• Other study ID #: A130886
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Symptoms
• Depression
• Depressive Symptoms

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Child Behavior Checklist Internalizing Scale score	T-scores range from 29 to 100 with higher values indicating more severe symptoms	Baseline to post-intervention, an anticipated average of 10 weeks
Primary	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