Foster Care Mental Health Family Navigator

NCT ID: NCT04506437

Last Updated: 2025-06-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-20

Study Completion Date

2025-04-01

Brief Summary

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This study will focus on developing and testing a family-based mental health navigator intervention, the Foster Care Family Navigator (FCFN), to evaluate whether the intervention combined with mHealth would be efficacious in improving mental health service initiation and engagement for child welfare-involved youth.

Detailed Description

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The study will demonstrate how a family-based navigator intervention combined with mHealth may lead to improved mental health treatment initiation and engagement among child welfare-involved (CWI) youth. CWI youth have high rates of mental health symptoms relative to youth in the community, and are disproportionately racial and ethnic minorities, only perpetuating disparities in this population's mental health access and engagement. The proposed project will develop and test a family-based navigator intervention, the Foster Care Family Navigator (FCFN), a natural fit for improving CWI youth mental health service and clinical outcomes. The study will start with identifying the feasibility and acceptability of the FCFN intervention. Then, the study will determine whether the FCFN intervention improves CWI youth mental health treatment initiation and engagement, relative to standard of care (not participating in FCFN intervention). Finally, the study will characterize patterns of pre- and post-service outcomes along the behavioral health services cascade of care, to further evaluate the feasibility, acceptability, and preliminary impact of the FCFN model.

Conditions

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Mental Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a dynamic wait-listed design in which the investigators will test a theory-driven family-based navigator treatment engagement intervention (FCFN) while also collecting data on the FCFN model's potential implementation and adoption within child welfare and behavioral health settings.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Family-based mental health navigation

Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement

Group Type EXPERIMENTAL

Family-based mental health navigation

Intervention Type BEHAVIORAL

Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement

Standard of care, then family-based mental health navigation

During wait-list period receive standard of care engagement practices and services-as-usual, and after the wait-list period the participants receive the family-based navigator intervention combined with mHealth practices

Group Type ACTIVE_COMPARATOR

Family-based mental health navigation

Intervention Type BEHAVIORAL

Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement

Standard of care engagement practices

Intervention Type BEHAVIORAL

Standard of care engagement practices and services-as-usual

Interventions

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Family-based mental health navigation

Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement

Intervention Type BEHAVIORAL

Standard of care engagement practices

Standard of care engagement practices and services-as-usual

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* English-speaking youth
* Ages 12-17
* Have an active dependency petition with the SF Unified Family Court (newly filed or existing when the trial starts)
* Are open to SF DPH Foster Care Mental Health Clinic services
* Have an involved caregiver/legal guardian for consent
* Family has mobile phone access

Exclusion Criteria

* Youth is not English-speaking
* Caregiver has impairment that would preclude providing informed consent
* Unavailable guardian for consent
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marina Tolou-Shams, Ph.D

Role: PRINCIPAL_INVESTIGATOR

UC San Francisco

Locations

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UCSF Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Site Status

Countries

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United States

References

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Tolou-Shams M, Ramaiya M, Lara Salas J, Ezimora I, Shumway M, Duerr Berrick J, Aguilera A, Borsari B, Dauria E, Friedling N, Holmes C, Grandi A. A Family-Based Mental Health Navigator Intervention for Youth in the Child Welfare System: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 12;12:e49999. doi: 10.2196/49999.

Reference Type DERIVED
PMID: 37698896 (View on PubMed)

Other Identifiers

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1R34MH119433-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R34MH119433-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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