Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

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.

Conditions

• Maternal Depression

Interventions

BEHAVIORAL

Problem-solving education (PSE)

PSE will be offered to mothers with low baseline depressive symptoms (the first, preventive step of the SCI). PSE participants will have their symptoms assessed at each session and will convert to Engagement Sessions if they meet pre-specified 'step up' criteria.

BEHAVIORAL

Engagement sessions

Engagement sessions will be offered to mothers with greater depressive symptoms to link them to formal mental health services (the second, referral step of the SCI)

BEHAVIORAL

Usual care

Normal services provided children and their mothers in Head Start

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Boston Medical Center

  collaborator OTHER

• Brown University

  lead OTHER

Principal Investigators

• Emily Feinberg, ScD CPNP · Brown University

• Michael Silverstein, MD · Brown University

• Amy Yule, MD · Boston Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-16

Primary Completion

2028-04-30

Completion

2028-04-30

Countries

• United States

Study Locations