Attachment and Biobehavioral Catch-up and Depression Treatment (ABC+D)
Primary Purpose
Maternal Depression, Child Behavior Problem
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attachment and Biobehavioral Catch up
Attachment and Biobehavioral Catch up Plus Depression Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Maternal Depression
Eligibility Criteria
Inclusion Criteria:
- 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)
- 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)
- English- or Spanish-speaking
Exclusion Criteria:
- 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
Sites / Locations
- University of California, San FranciscoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
ABC
ABC+D
Arm Description
Attachment and Biobehavioral Catch-up, 10 weekly sessions that provide parenting support
Attachment and Biobehavioral Catch-up plus weekly 5-10 minute videos that additional provide support for mothers' mood, stress, and coping
Outcomes
Primary Outcome Measures
Change in Center for Epidemiologic Studies Depression Scale score
Scores range from 0 to 60 with higher values indicating more severe symptoms
Change in Early Childhood Screening Assessment score
Scores range from 0 to 72 with higher values indicating more severe symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT05096611
First Posted
October 25, 2021
Last Updated
July 3, 2023
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT05096611
Brief Title
Attachment and Biobehavioral Catch-up and Depression Treatment
Acronym
ABC+D
Official Title
Efficacy of an Integrated Intervention to Treat Maternal Depression and Children's Behavior Problems: A Transactional Perspective
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Depression, Child Behavior Problem
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ABC
Arm Type
Active Comparator
Arm Description
Attachment and Biobehavioral Catch-up, 10 weekly sessions that provide parenting support
Arm Title
ABC+D
Arm Type
Experimental
Arm Description
Attachment and Biobehavioral Catch-up plus weekly 5-10 minute videos that additional provide support for mothers' mood, stress, and coping
Intervention Type
Behavioral
Intervention Name(s)
Attachment and Biobehavioral Catch up
Other Intervention Name(s)
ABC
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attachment and Biobehavioral Catch up Plus Depression Treatment
Other Intervention Name(s)
ABC+D
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Center for Epidemiologic Studies Depression Scale score
Description
Scores range from 0 to 60 with higher values indicating more severe symptoms
Time Frame
Baseline to post-intervention, an anticipated average of 10 weeks
Title
Change in Early Childhood Screening Assessment score
Description
Scores range from 0 to 72 with higher values indicating more severe symptoms
Time Frame
Baseline to post-intervention, an anticipated average of 10 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
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)
English- or Spanish-speaking
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Roubinov, PhD
Phone
415-476-2259
Email
danielle.roubinov@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Roubinov, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared via the NIMH Data Archive (NDA)
IPD Sharing 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.
IPD Sharing Access Criteria
Researchers will the appropriate qualifications can request the dataset via the NIMH Data Archive Platform.
Learn more about this trial
Attachment and Biobehavioral Catch-up and Depression Treatment
We'll reach out to this number within 24 hrs