Child Behavior Problem, Maternal Depression
Conditions
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.
Interventions
BEHAVIORALAttachment and Biobehavioral Catch up
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.
BEHAVIORALAttachment and Biobehavioral Catch up Plus Depression Treatment
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.
Sponsors
University of California, San Francisco
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
2 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score | 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 | Baseline to post-intervention. This is approximately 10 weeks. | Scores range from 0 to 80 with higher values indicating more severe symptoms |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDanielle Roubinov, PhD
University of California, San Francisco
Participant flow
Recruitment details
Participants were recruited between March 2022 and August 2024. Recruitment occurred online.
Pre-assignment details
The number of enrolled participants reflect the total number of mothers and children. There were 38 dyads enrolled in the study reflecting 38 mothers and 38 offspring (76 total participants).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 16 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Age, Continuous Child age in years | 3.38 Years STANDARD_DEVIATION 0.74 |
| Age, Continuous Mother age in years | 33.79 Years STANDARD_DEVIATION 6.27 |
| Ethnicity (NIH/OMB) Child ethnicity Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Child ethnicity Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Child ethnicity Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Mother ethnicity Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Mother ethnicity Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Mother ethnicity Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Child race American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Child race Asian | 1 Participants |
| Race (NIH/OMB) Child race Black or African American | 2 Participants |
| Race (NIH/OMB) Child race More than one race | 5 Participants |
| Race (NIH/OMB) Child race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Child race Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) Child race White | 10 Participants |
| Race (NIH/OMB) Mother race American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Mother race Asian | 5 Participants |
| Race (NIH/OMB) Mother race Black or African American | 3 Participants |
| Race (NIH/OMB) Mother race More than one race | 3 Participants |
| Race (NIH/OMB) Mother race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Mother race Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) Mother race White | 12 Participants |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Child biological sex Female | 13 Participants |
| Sex: Female, Male Child biological sex Male | 9 Participants |
| Sex: Female, Male Mother biological sex Female | 16 Participants |
| Sex: Female, Male Mother biological sex Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 44 |
| other Total, other adverse events | 0 / 32 | 0 / 44 |
| serious Total, serious adverse events | 0 / 32 | 0 / 44 |
Outcome results
None listed