Clinical Trials Directory

Trials / Completed

CompletedNCT05096611

Attachment and Biobehavioral Catch-up and Depression Treatment

Efficacy of an Integrated Intervention to Treat Maternal Depression and Children's Behavior Problems: A Transactional Perspective

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
76 (actual)
Sponsor
University of California, San Francisco · Academic / Other
Sex
Female
Age
2 Years
Healthy volunteers
Accepted

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.

Detailed description

The proposed project is a pilot randomized controlled trial to evaluate the effectiveness of an integrated intervention that dually treats maternal depressive symptoms and offspring behavior problems. Families (n = 40 mothers and their 2-to-4 year-old children) will be randomized to receive 10 sessions of ABC or 10 sessions of ABC+D in their home. ABC+D is an expanded version of ABC that additionally treats maternal depressive symptoms using Mothers and Babies adapted for mothers of toddlers. The specific aims of this proposed project are: Aim 1. Collect preliminary data on the feasibility and acceptability of ABC+D in preparation for a small pilot randomized controlled trial (RCT). Aim 2. Conduct a small pilot RCT to examine the effectiveness of ABC and ABC+D Aim 3: Assess the overall acceptability (mother- and provider-rated), appropriateness (mother- and provider-rated), and feasibility (provider-rated) of ABC+D. Mothers will also rate their satisfaction with each session and the degree to which it was helpful, interesting, and comprehensible.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAttachment and Biobehavioral Catch upABC 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.
BEHAVIORALAttachment and Biobehavioral Catch up Plus Depression TreatmentABC+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.

Timeline

Start date
2022-03-01
Primary completion
2024-10-30
Completion
2024-10-30
First posted
2021-10-27
Last updated
2025-06-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05096611. Inclusion in this directory is not an endorsement.