Efficacy of an Integrated Intervention to Treat Maternal Depression and Children's Behavior Problems: A Transactional Perspective
Overview
- Phase
- Not Applicable
- Intervention
- Attachment and Biobehavioral Catch up
- Conditions
- Maternal Depression
- Sponsor
- University of California, San Francisco
- Enrollment
- 76
- Locations
- 2
- Primary Endpoint
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score
- Status
- Completed
- Last Updated
- 11 days ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
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
Arms & Interventions
ABC
Attachment and Biobehavioral Catch-up, 10 weekly sessions that provide parenting support
Intervention: Attachment and Biobehavioral Catch up
ABC+D
Attachment and Biobehavioral Catch-up plus weekly 5-10 minute videos that additional provide support for mothers' mood, stress, and coping
Intervention: Attachment and Biobehavioral Catch up Plus Depression Treatment
Outcomes
Primary Outcomes
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score
Time Frame: Baseline to post-intervention. This is an anticipated average of 10 weeks.
Scores range from 34.5 to 82.3 with higher values indicating more severe symptoms
Change in Early Childhood Screening Assessment score
Time Frame: Baseline to post-intervention. This is an anticipated average of 10 weeks.
Scores range from 0 to 72 with higher values indicating more severe symptoms
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score
Time Frame: Baseline to post-intervention. This is approximately 10 weeks.
Scores range from 34.5 to 82.3 with higher values indicating more severe symptoms
Change in Early Childhood Screening Assessment (ECSA) Score
Time Frame: Baseline to post-intervention. This is approximately 10 weeks.
Scores range from 0 to 80 with higher values indicating more severe symptoms