Attachment and Biobehavioral Catch-up and Depression Treatment

NCT05096611 | Completed Results

• 2 other identifiers: A137439R56MH127032
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Maternal depression influences the development of children's behavior problems and vice versa; however most interventions singularly address maternal depression or children's behavior problems rather than both. This project assesses the efficacy of an intervention that treats both mothers and children in an integrated manner. Effects are expected to disrupt the reciprocal relations that perpetuate maternal and child mental health problems over time.

Conditions

Maternal Depression; Child Behavior Problem

Outcome Measures

Primary Outcomes (2)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score

  Scores range from 34.5 to 82.3 with higher values indicating more severe symptoms

  Baseline to post-intervention. This is approximately 10 weeks.

• Change in Early Childhood Screening Assessment (ECSA) Score

  Scores range from 0 to 80 with higher values indicating more severe symptoms

  Baseline to post-intervention. This is approximately 10 weeks.

Study Arms (2)

ABC

ACTIVE COMPARATOR

Attachment and Biobehavioral Catch-up, 10 weekly sessions that provide parenting support

Behavioral: Attachment and Biobehavioral Catch up

ABC+D

EXPERIMENTAL

Attachment and Biobehavioral Catch-up plus weekly 5-10 minute videos that additional provide support for mothers' mood, stress, and coping

Behavioral: Attachment and Biobehavioral Catch up Plus Depression Treatment

Interventions

Attachment and Biobehavioral Catch up BEHAVIORAL

ABC is delivered by a trained parent coach. The parent coach provides information about parenting and child development. The focus is on providing support for parents of young children and improving the parent-child relationship.

Also known as: ABC

ABC

Attachment and Biobehavioral Catch up Plus Depression Treatment BEHAVIORAL

ABC+D offers the same 10-sessions of parenting support that is provided by ABC and additionally provides weekly short videos that help mothers develop skills for coping with stress and regulating mood.

Also known as: ABC+D

ABC+D

Eligibility Criteria

• Age: 2 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers 18 years of age or older with heightened depressive symptoms as determined by a score of 5 or higher on the Patient Health Questionnaire-9 (PHQ-9)
• Biological children (of mothers described above) between 2 and 4 years old with heightened behavior problems as determined by a score of at least 3 in at least 1 domain of functioning on the Impairment Rating Scales
• English- or Spanish-speaking

You may not qualify if:

• Self-reported history of psychosis or active suicidality as defined by self-report of a specific suicide plan or recent attempt
• Child diagnosis of autism

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

Results Point of Contact

• Title: Danielle Roubinov
• Organization: University of North Carolina at Chapel Hill

danielle_roubinov@med.unc.edu

9198435898

Study Officials

• Danielle Roubinov, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: October 27, 2021
• Study Start: March 1, 2022
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: April 21, 2026
• Results First Posted: April 21, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data from this clinical trial require significant processing after the completion of data collection. We will submit a clean dataset after the final data lock.
• Access Criteria: Researchers will the appropriate qualifications can request the dataset via the NIMH Data Archive Platform.

Locations

US (1)