Clinical trial NCT04092010: Improving Preschool Outcomes by Addressing Maternal Depression in Head Start
Official title: Improving Preschool Outcomes by Addressing Maternal Depression in Head Start
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maternal Depression
Keywords: Stepped care intervention
Problem solving education
Engagement session
Head Start
Preschool children
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Boston Medical Center
First posted: 2019-09-17
Enrollment: 388
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Within a research network of Head Start centers in Massachusetts, an efficacy trial of a stepped-care intervention (SCI) to address maternal depression, using intervention components that both prevent depression and help those in major depressive episode (MDE) engage with care, will be conducted. Both the prevention and engagement components of the model have strong, supportive randomized trial evidence for both their efficacy and safety; but they have yet to be synthesized and tested within a coordinated intervention, applicable to a broad population base. Stepped-care interventions are commonly used in mental health service projects, in which the intensity or type of service is calibrated to the severity of illness.

Detailed description: This research study is a community-based efficacy trial (n=388) of a stepped-care model intervention to strengthen the capacity of Head Start to address parental depression and related adversities. Head Start mothers with symptoms of depressed mood or anhedonia, and their Head Start children, are enrolled across 12 Head Start centers.

The research study aims to improve developmental outcomes for Head Start children by delivering stepped care intervention that incorporates depression prevention and linkage to formal mental health care to mothers. Mothers with low baseline depressive symptoms are offered a problem-solving intervention while mothers with greater symptoms are offered engagement sessions to link them to formal mental health services. At each problem-solving session participant's symptoms are assessed and if the symptoms meet pre-specified 'step-up' criteria, they are converted to Engagement sessions.

Over 12 months, the intervention's effect will be assessed on a series of outcome measures for mothers; mechanisms by which maternal depression is theorized to impact young children; and child outcomes.

Eligibility criteria: Inclusion Criteria:

* Mother of a 0 to 5-year-old Head Start child
* Mother speaks English or Spanish

Exclusion Criteria:

* Mother with suicidal ideation
* Mother with cognitive limitation

Primary outcomes:
measure: Change in incident rates of moderate to severe maternal depressive symptoms based on the QIDS
timeFrame: Baseline, 2, 4, 6, 8, 10, 12 months follow-up
measure: Change in the mean maternal depressive symptoms based on the QIDS
timeFrame: Baseline, 2, 4, 6, 8, 10, 12 months follow-up
Secondary outcomes:
measure: Rate of participants engaged with care based on 1 or more psycho/pharmacotherapy visits or psychiatric medication prescription
timeFrame: Baseline, 2, 4, 6, 8, 10, 12 months follow-up
measure: Rate of participants retained in care based on 4 or more psycho/pharmacotherapy visits or psychiatric medication prescription
timeFrame: 2, 4, 6, 8, 10, 12 months
measure: Rate of participants who received evidence-based care defined by psychotherapy or antidepressant medication prescription
timeFrame: 2, 4, 6, 8, 10, 12 months
measure: Rate of participants who received primary-care based services
timeFrame: 2, 4, 6, 8, 10, 12 months
measure: Burden of illness for depression
timeFrame: baseline; 6, 12 months
measure: Child absenteeism from Head Start
timeFrame: baseline; 6, 12 months
measure: Caregiver-Teacher Report Form
timeFrame: baseline; 6, 12 months
measure: Social Skills Improvement System - Rating Scales
timeFrame: baseline; 6, 12 months
measure: Bracken School Readiness Assessment
timeFrame: baseline; 6, 12 months
measure: Perceived Stress
timeFrame: baseline, 4, 8, 12 months
measure: Behavioral Activation for Depression
timeFrame: baseline, 4, 8, 12 months
measure: Coping Strategies
timeFrame: baseline, 4, 8, 12 months
measure: Parent-Child Interaction
timeFrame: baseline, 6, 12 months
measure: Family Conflict
timeFrame: Baseline, 6, 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Brown University
name: Emily Feinberg, ScD CPNP
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Michael Silverstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center
name: Amy Yule, MD
role: PRINCIPAL_INVESTIGATOR
References: