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Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

NCT ID: NCT04092010

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

388 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-16

Study Completion Date

2028-04-30

Brief Summary

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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

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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.

Conditions

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Maternal Depression

Keywords

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Stepped care intervention Problem solving education Engagement session Head Start Preschool children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Stepped-care intervention (SCI) group

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.

Group Type EXPERIMENTAL

Problem-solving education (PSE)

Intervention Type BEHAVIORAL

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.

Engagement sessions

Intervention Type BEHAVIORAL

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)

Usual care control group

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

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Normal services provided children and their mothers in Head Start

Interventions

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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.

Intervention Type 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)

Intervention Type BEHAVIORAL

Usual care

Normal services provided children and their mothers in Head Start

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emily Feinberg, ScD CPNP

Role: PRINCIPAL_INVESTIGATOR

Brown University

Michael Silverstein, MD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Amy Yule, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amy Yule, MD

Role: CONTACT

Phone: (617) 414-1936

Email: [email protected]

Jocelyn Antonio, MPH

Role: CONTACT

Phone: 401-863-2259

Email: [email protected]

Facility Contacts

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Amy Yule, MD

Role: primary

Other Identifiers

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1R01HD092456-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022003398

Identifier Type: -

Identifier Source: org_study_id