Family Mental Health Family Navigator Project (FMHN) (FMHN)
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ClinicalTrials.gov Identifier: NCT04822636 |
Recruitment Status :
Recruiting
First Posted : March 30, 2021
Last Update Posted : July 6, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mental Health | Behavioral: Family-based mental health navigation Behavioral: Standard of care engagement practices | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 130 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This is a dynamic wait-listed 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. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Family Mental Health Family Navigator |
Estimated Study Start Date : | January 15, 2022 |
Estimated Primary Completion Date : | January 31, 2023 |
Estimated Study Completion Date : | January 31, 2023 |

Arm | Intervention/treatment |
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Experimental: Family-based mental health navigation
Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement
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Behavioral: Family-based mental health navigation
Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement |
Active Comparator: 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
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Behavioral: Family-based mental health navigation
Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement Behavioral: Standard of care engagement practices Standard of care engagement practices and services- as-usual |
- Time to treatment referral [ Time Frame: 12 months post enrollment ]Number of days until treatment referral is made
- Time to treatment initiation [ Time Frame: 12 months post enrollment ]Number of days until attendance at first treatment session
- Treatment engagement [ Time Frame: 12 months post enrollment ]Engagement as measured by attendance in treatment for 6 or more weeks

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Ages Eligible for Study: | 12 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- English-speaking and/or Spanish-speaking youth
- Ages 12-17
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04822636
Contact: Marina Tolou-Shams, Ph.D | 628-206-2212 | marina.tolou-shams@ucsf.edu | |
Contact: Catalina Ordorica, M.Ed | 628-206-2822 | catalina.ordorica@ucsf.edu |
United States, California | |
UCSF Zuckerberg San Francisco General Hospital | Recruiting |
San Francisco, California, United States, 94131 | |
Contact: Marina Tolou-Shams, PhD 628-206-2212 marina.tolou-shams@ucsf.edu |
Principal Investigator: | Marina Tolou-Shams, Ph.D | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT04822636 |
Other Study ID Numbers: |
1929675 |
First Posted: | March 30, 2021 Key Record Dates |
Last Update Posted: | July 6, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Adolescent Publicly-insured Youth Mental Health Navigator Service Access |