N/A
N=38
Attachment and Biobehavioral Catch-up and Depression Treatment
Maternal Depression · Child Behavior Problem
Bottom Line
View on ClinicalTrials.gov: NCT05096611 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score — 6.70; 6.98 units on a scale — p=.85
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Attachment and Biobehavioral Catch up (Behavioral); Attachment and Biobehavioral Catch up Plus Depression Treatment (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- Female
- Sponsor
- University of California, San Francisco
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score |
6.70; 6.98 | .85 |
| PRIMARY Change in Early Childhood Screening Assessment (ECSA) Score |
10.12; 8.67 | 0.45 |
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.
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
Data sourced from ClinicalTrials.gov (NCT05096611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.