Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

Brown University

Status: Enrolling

Conditions: Maternal Depression

Treatments: Behavioral: Usual care; Behavioral: Engagement sessions; Behavioral: Problem-solving education (PSE)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04092010

1R01HD092456-01A1 (U.S. NIH Grant/Contract)

2022003398

Details and patient eligibility

About

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.

Full 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.

Enrollment: 388 estimated patients

Sex: Female

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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388 participants in 2 patient groups

Stepped-care intervention (SCI) group

Experimental group

Description:

In the SCI group, mothers with low baseline depressive symptoms are offered the problem-solving education (PSE) prevention intervention, and mothers with greater depressive symptoms are offered Engagement Sessions.

Treatment:

Behavioral: Problem-solving education (PSE)

Behavioral: Engagement sessions

Usual care control group

Active Comparator group

Description:

Families in the control group will receive usual Head Start services.

Treatment:

Behavioral: Usual care