Attachment and Biobehavioral Catch-up and Depression Treatment (ABC+D)

University of California San Francisco (UCSF)

Status: Active, not recruiting

Conditions: Maternal Depression; Child Behavior Problem

Treatments: Behavioral: Attachment and Biobehavioral Catch up; Behavioral: Attachment and Biobehavioral Catch up Plus Depression Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05096611

R56MH127032 (U.S. NIH Grant/Contract)

A137439

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: Female

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

ABC

Active Comparator group

Description:

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

Treatment:

Behavioral: Attachment and Biobehavioral Catch up

ABC+D

Experimental group

Description:

Attachment and Biobehavioral Catch-up plus weekly 5-10 minute videos that additional provide support for mothers' mood, stress, and coping

Treatment:

Behavioral: Attachment and Biobehavioral Catch up Plus Depression Treatment