Clinical trial NCT05096611: Attachment and Biobehavioral Catch-up and Depression Treatment
Official title: Efficacy of an Integrated Intervention to Treat Maternal Depression and Children's Behavior Problems: A Transactional Perspective
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Depression
Child Behavior Problem
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-10-27
Enrollment: 76
Sex: FEMALE
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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)
2. 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
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

Primary outcomes:
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score
timeFrame: Baseline to post-intervention. This is an anticipated average of 10 weeks.
measure: Change in Early Childhood Screening Assessment score
timeFrame: Baseline to post-intervention. This is an anticipated average of 10 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Danielle Roubinov, PhD
role: PRINCIPAL_INVESTIGATOR
References: