Family Mental Health Family Navigator Project (FMHN)

NCT ID: NCT04822636

Last Updated: 2025-04-07

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-06

Study Completion Date

2026-04-01

Brief Summary

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This study will focus on developing and testing a family-based mental health navigator intervention, the Family Mental Health Navigator (FMHN), to evaluate whether the intervention combined with mHealth is preliminary efficacious in improving mental health service initiation and engagement for publicly-insured 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 publicly-insured youth. Publicly-insured 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 Family Mental Health Navigator (FMHN), a natural fit for improving publicly-insured youth's mental health service and clinical outcomes. The study will start with identifying the feasibility and acceptability of the FMHN intervention. Then, the study will determine whether the FMHN intervention improves publicly-insured youth mental health treatment initiation and engagement. 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 FMHN model.

Conditions

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Mental Health

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a within-person, pre-post design in which the investigators will test a theory-driven, family-based navigator treatment engagement intervention (FMHN) while also collecting data on the FMHN model's potential implementation and adoption within a public hospital 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

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

Eligibility Criteria

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Inclusion Criteria

* English-speaking and/or Spanish-speaking youth
* Ages 6-17
* Are currently receiving services at the San Francisco General Hospital
* Are publicly insured
* Have an involved caregiver/legal guardian for consent
* Family has mobile phone access

Exclusion Criteria

* Youth is not English-speaking nor Spanish-speaking
* Caregiver has impairment that would preclude providing informed consent
* Unavailable guardian for consent
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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San Francisco General Hospital Foundation

UNKNOWN

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

University of California, San Francisco

Locations

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UCSF Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Marina Tolou-Shams, Ph.D

Role: CONTACT

628-206-2212

Juliet Yonek, Ph.D.

Role: CONTACT

628-206-2452

Facility Contacts

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Marina Tolou-Shams, PhD

Role: primary

628-206-2212

Other Identifiers

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1929675

Identifier Type: -

Identifier Source: org_study_id

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