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ABC+D: Attachment and Biobehavioral Catch-up and Depression Treatment

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT05096611
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
17
Anticipated Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Attachment and Biobehavioral Catch up
  • Behavioral: Attachment and Biobehavioral Catch up Plus Depression Treatment
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of an Integrated Intervention to Treat Maternal Depression and Children's Behavior Problems: A Transactional Perspective
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: ABC

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

Behavioral: Attachment and Biobehavioral Catch up
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.
Other Names:
  • ABC

    		•
    Experimental: ABC+D

    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
    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.
    Other Names:
  • ABC+D

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Center for Epidemiologic Studies Depression Scale score [Baseline to post-intervention, an anticipated average of 10 weeks]

      Scores range from 0 to 60 with higher values indicating more severe symptoms

    2. Change in Early Childhood Screening Assessment score [Baseline to post-intervention, an anticipated average of 10 weeks]

      Scores range from 0 to 72 with higher values indicating more severe symptoms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Mothers 18 years of age or older 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 behavior problems as determined by a score of 18 or higher on the Early Childhood Screening Assessment (ECSA)

    3. English- or Spanish-speaking

    Exclusion Criteria:

    1. Self-reported history of psychosis or active suicidality as defined by self-report of a specific suicide plan or recent attempt

    2. Child diagnosis of autism

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco San Francisco California United States 94118

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    • Principal Investigator: Danielle Roubinov, PhD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT05096611
    Other Study ID Numbers:
    • A137439
    First Posted:
    Oct 27, 2021
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder
    Problem Behavior

    Study Results

    No Results Posted as of Jun 15, 2022