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NCT Number: NCT04822636

Family Mental Health Family Navigator Project (FMHN)

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.

Recruiting

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Zuckerberg San Francisco General Hospital

San Francisco, California, 94131, United States

Location status: Recruiting

Location contact

Marina Tolou-Shams, PhD

CONTACT

[email protected]

628-206-2212

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family-based mental health navigation

Behavioral

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

Primary outcomes

  1. Time to treatment referral

    Time frame: 12 months post enrollment

    Number of days until treatment referral is made

  2. Time to treatment initiation

    Time frame: 12 months post enrollment

    Number of days until attendance at first treatment session

  3. Treatment engagement

    Time frame: 12 months post enrollment

    Engagement as measured by attendance in treatment for 6 or more weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Juliet Yonek, Ph.D.

CONTACT

[email protected]

628-206-2452

Marina Tolou-Shams, Ph.D

CONTACT

[email protected]

628-206-2212

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • San Francisco General Hospital Foundation

Registry information

Official study title

Family Mental Health Family Navigator

Acronym: FMHN

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2021
Registry last updated
Apr 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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