Mental HealthFMHNNCT04822636
Family Mental Health Family Navigator Project (FMHN)
A study testing Family-based mental health navigation in people with Mental Health, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- Family-based mental health navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2022to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Youth is not English-speaking nor Spanish-speaking
- Caregiver has impairment that would preclude providing informed consent
- Unavailable guardian for consent
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Zuckerberg San Francisco General Hospital
San Francisco, California, 94131
About this study
Official title: Family Mental Health Family Navigator
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.
Read the detailed description
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
- Mental Health
- Being tested
- Family-based mental health navigation
- Keywords
- Adolescent, Publicly-insured Youth, Mental Health, Navigator Service, Access, Children
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based mental health navigationBehavioural
Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement
| Study group | Role | What they receive |
|---|---|---|
| Family-based mental health navigation | Experimental | Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement Receives: Behavioral: Family-based mental health navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment referral
Number of days until treatment referral is made
Measured: 12 months post enrollment
Time to treatment initiation
Number of days until attendance at first treatment session
Measured: 12 months post enrollment
Treatment engagement
Engagement as measured by attendance in treatment for 6 or more weeks
Measured: 12 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start6 Jun 2022
- Primary completion1 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco General Hospital Foundation
- Responsible party
- Sponsor
- Investigators
- Marina Tolou-Shams, Ph.D, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822636
- Sponsor's protocol ID
- 1929675
- Acronym
- FMHN
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2021
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Mental Health Family Navigator
- ClinicalTrials.gov ID
- NCT04822636
- Acronym / sponsor ID
- FMHN / 1929675
- Conditions
- Mental Health
- Keywords
- Adolescent, Publicly-insured Youth, Mental Health, Navigator Service, Access, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco General Hospital Foundation
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Family-based mental health navigation | Experimental | Behavioral: Family-based mental health navigationFamily-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Youth is not English-speaking nor Spanish-speaking
- Caregiver has impairment that would preclude providing informed consent
- Unavailable guardian for consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-based mental health navigationFamily-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement | Behavioural | Family-based mental health navigation |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Mental Health
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Tolou-Shams, Ph.D principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-based mental health navigation in people with Mental Health, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to treatment referral (time frame: 12 months post enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.