AnxietyNCT06122688
By Youth, For Youth: Digital Supported Peer Navigation for Addressing Child Mental Health Care
A study testing Navigator Plus App Intervention in people with Anxiety and Depression, run by University of California, Riverside.
Trial summary
Despite significant progress in research, practice, and policy over the past few decades, many children and youth continue to experience poor mental health outcomes. With their unrivaled ability to reach youth, school-based services and primary care are ideal hubs to provide mental health, healthcare, social services… Read more about this study
- Who is it for?
- Ages 13 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Mental Health Issue
- What is being tested?
- Navigator Plus App Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,360 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Youth 13-22 enrolled in high school or participating primary care clinics, and their caregivers.
Who cannot join
- Those not meeting inclusion criteria
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sheryl Kataoka, MD, MSHS contact
About this study
Despite significant progress in research, practice, and policy over the past few decades, many children and youth continue to experience poor mental health outcomes. With their unrivaled ability to reach youth, school-based services and primary care are ideal hubs to provide mental health, healthcare, social services, and prevention to youth and families who otherwise face barriers to care. Using Participatory Design and Community Partnered Participatory Research (CPPR) for app development, mobile technology is designed to optimize access to wellness resources. The proposed intervention is a model of care using technology and navigators for connecting youth ages 13-22 to mental health care and supports. The app is co-created with the community and supported by culturally responsive individuals called family and youth navigators, in schools and primary care clinics. Outcomes are measured using the cascade of care model.
Read the detailed description
Using Participatory Design and Community Partnered Participatory Research (CPPR), UCLA and UCR psychiatry research centers with Los Angeles Trust for Children's Health aim to: (1) Fully co-design (with youth, caregivers, clinicians and other stakeholders) an innovative mental health digital tool, called Connected for Wellness, to implement algorithmically supported mental health + social determinants, resiliency app based tools and navigation activities AND help support the clinical workforce within schools and primary care clinics (PCCs); (2) Study the implementation of mental health navigation models (family and youth navigation) plus the Connected for Wellness app, and their effectiveness for improving connecting and matching youth to the right level of care and supports. We will accomplish these aims through three strategies: (1) Use community participatory informatics to co-design a mental health digital tool called Connected for Wellness, to support mental health navigation, linking youth to a range of mental health services, evidence-based prevention resources referred via the app, and other school, clinic, community, and social supports; (2) Integrate mental health self-assessments and artificial intelligence (AI) in Connected for Wellness to individualize app resources, optimize engagement and recommendations for addressing mental health and social needs; (3) Using a stepped wedge design, test the implementation of the app supported by mental health navigation models (peer navigators, family navigators) for improving connections and access to prevention resources, mental health services and social supports, for youth and families. This project will be initiated with youth 13-22 years old and their family and community members across 10 Los Angeles County Schools and 10 Riverside County/University of California Riverside primary care clinics. A successful outcome of the project is a CPPR developed app-based intervention implementable in school-based and primary care services for access to wellness resources and improving mental health services access along the cascade of care. Outcomes are measured using the cascade of care model with the following key stages: (1) need identification, (2) referral to care/ linkage to resources, and (3) care initiation.
- Conditions
- Anxiety, Depression, Mental Health Issue
- Being tested
- Navigator Plus App Intervention
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigator Plus App InterventionBehavioural
Navigators will provide their usual care services and also be encouraged to use the Connected for Wellness (CFW) app during their usual activities with youth and caregivers at their site. The duration of this period (2, 3, or 4 years) will depend on the step period of the individual's site. All youth at the school or clinic site can use the CFW app on their own and through the app receive prevention strategies, psycho-education that destigmatizes mental health, encourages referrals to local resources as needed, and increases motivation to access care if needed.
| Study group | Role | What they receive |
|---|---|---|
| Care as usual | No intervention | All individuals within each site regardless of type of site or step period will begin with a control period of care as usual Youth and parents within each site will have access to navigators who will share information about mental health and social services supports as well as referrals. The duration of the control period (1, 2, or 3 years; collected via medical and/or other administrative records) will depend on the step period of the individual's site. |
| Implementation | Experimental | In this stepped wedge design, following a period of care as usual as a control, sites will then cross over to the experimental arm, during which, all youth and their caregivers at the enrolled site are encouraged to download and use the wellness app for the duration of the implementation period. Navigators promote and support use of the app. Receives: Behavioral: Navigator Plus App Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of youth referred to mental health services who initiate care.
Referral to and initiation of mental health services data will be obtained from electronic medical records.
Measured: 1 year
Secondary outcomes (1)
Proportion of youth completing a mental health screening who are referred to care.
Mental health screening and referral to mental health services data will be obtained from electronic medical records.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In each county, 10 sites will participate (10 high schools in Los Angeles and 10 Primary Care Clinics in Riverside), with sites randomized to cross over from control to intervention status in a step wedged design each Fall following the beginning of the school year. Three months is allowed for training and setup at each site prior to intervention delivery.
- Masking
- None (open label)
- Enrolment
- 8,360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Riverside
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, University of California, Los Angeles, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122688
- Sponsor's protocol ID
- U01MH131827
- Status last verified
- Jan 2026
- First submitted
- 31 Oct 2023
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cook BL, Trinh NH, Li Z, Hou SS, Progovac AM. Trends in Racial-Ethnic Disparities in Access to Mental Health Care, 2004-2012. Psychiatr Serv. 2017 Jan 1;68(1):9-16. doi: 10.1176/appi.ps.201500453. Epub 2016 Aug 1.
PubMed 27476805Marrast L, Himmelstein DU, Woolhandler S. Racial and Ethnic Disparities in Mental Health Care for Children and Young Adults: A National Study. Int J Health Serv. 2016 Oct;46(4):810-24. doi: 10.1177/0020731416662736. Epub 2016 Aug 12.
PubMed 27520100Kataoka SH, Vona P, Acuna A, Jaycox L, Escudero P, Rojas C, Ramirez E, Langley A, Stein BD. Applying a Trauma Informed School Systems Approach: Examples from School Community-Academic Partnerships. Ethn Dis. 2018 Sep 6;28(Suppl 2):417-426. doi: 10.18865/ed.28.S2.417. eCollection 2018.
PubMed 30202195Arevian AC, Jones F, Moore EM, Goodsmith N, Aguilar-Gaxiola S, Ewing T, Siddiq H, Lester P, Cheung E, Ijadi-Maghsoodi R, Gabrielian S, Sugarman OK, Bonds C, Benitez C, Innes-Gomberg D, Springgate B, Haywood C, Meyers D, Sherin JE, Wells K. Mental Health Community and Health System Issues in COVID-19: Lessons from Academic, Community, Provider and Policy Stakeholders. Ethn Dis. 2020 Sep 24;30(4):695-700. doi: 10.18865/ed.30.4.695. eCollection 2020 Fall.
PubMed 32989370Balcombe L, De Leo D. Digital Mental Health Challenges and the Horizon Ahead for Solutions. JMIR Ment Health. 2021 Mar 29;8(3):e26811. doi: 10.2196/26811.
PubMed 33779570Ellis DM, Draheim AA, Anderson PL. Culturally adapted digital mental health interventions for ethnic/racial minorities: A systematic review and meta-analysis. J Consult Clin Psychol. 2022 Oct;90(10):717-733. doi: 10.1037/ccp0000759. Epub 2022 Oct 13.
PubMed 36227330Fortuna LR, Tolou-Shams M, Robles-Ramamurthy B, Porche MV. Inequity and the disproportionate impact of COVID-19 on communities of color in the United States: The need for a trauma-informed social justice response. Psychol Trauma. 2020 Jul;12(5):443-445. doi: 10.1037/tra0000889. Epub 2020 Jun 1.
PubMed 32478545Lyon AR, Koerner K. User-Centered Design for Psychosocial Intervention Development and Implementation. Clin Psychol (New York). 2016 Jun;23(2):180-200. doi: 10.1111/cpsp.12154. Epub 2016 Jun 17.
PubMed 29456295Park SY, Nicksic Sigmon C, Boeldt D. A Framework for the Implementation of Digital Mental Health Interventions: The Importance of Feasibility and Acceptability Research. Cureus. 2022 Sep 19;14(9):e29329. doi: 10.7759/cureus.29329. eCollection 2022 Sep.
PubMed 36277565Porche MV, Folk JB, Tolou-Shams M, Fortuna LR. Researchers' Perspectives on Digital Mental Health Intervention Co-Design With Marginalized Community Stakeholder Youth and Families. Front Psychiatry. 2022 Apr 22;13:867460. doi: 10.3389/fpsyt.2022.867460. eCollection 2022.
PubMed 35530032Fortuna LR, Porche MV, Shumway M, Ijadi-Maghsoodi R, Aralis H, Folk JB, Tolou-Shams M, Barish G, Gonzalez JC, Kataoka S. Addressing Youth Mental Health Through Schools and Primary Care Clinics Using the Connected for Wellness Mobile App: Protocol for a Stepped-Wedge Trial. JMIR Res Protoc. 2025 Aug 26;14:e73721. doi: 10.2196/73721.
PubMed 40857099
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- By Youth, For Youth: Digital Supported Peer Navigation for Addressing Child Mental Health Care
- ClinicalTrials.gov ID
- NCT06122688
- Acronym / sponsor ID
- U01MH131827
- Conditions
- Anxiety, Depression, Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8,360 participants (estimated)
- Lead sponsor
- University of California, RiversideUniversity, hospital or other
- Collaborators
- University of California, San Francisco, University of California, Los Angeles, National Institute of Mental Health (NIMH)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 8 Nov 2023 (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.
Despite significant progress in research, practice, and policy over the past few decades, many children and youth continue to experience poor mental health outcomes. With their unrivaled ability to reach youth, school-based services and primary care are ideal hubs to provide mental health, healthcare, social services, and prevention to youth and families who otherwise face barriers to care. Using Participatory Design and Community Partnered Participatory Research (CPPR) for app development, mobile technology is designed to optimize access to wellness resources. The proposed intervention is a model of care using technology and navigators for connecting youth ages 13-22 to mental health care and supports. The app is co-created with the community and supported by culturally responsive individuals called family and youth navigators, in schools and primary care clinics. Outcomes are measured using the cascade of care model.
Detailed description
Using Participatory Design and Community Partnered Participatory Research (CPPR), UCLA and UCR psychiatry research centers with Los Angeles Trust for Children's Health aim to: (1) Fully co-design (with youth, caregivers, clinicians and other stakeholders) an innovative mental health digital tool, called Connected for Wellness, to implement algorithmically supported mental health + social determinants, resiliency app based tools and navigation activities AND help support the clinical workforce within schools and primary care clinics (PCCs); (2) Study the implementation of mental health navigation models (family and youth navigation) plus the Connected for Wellness app, and their effectiveness for improving connecting and matching youth to the right level of care and supports. We will accomplish these aims through three strategies: (1) Use community participatory informatics to co-design a mental health digital tool called Connected for Wellness, to support mental health navigation, linking youth to a range of mental health services, evidence-based prevention resources referred via the app, and other school, clinic, community, and social supports; (2) Integrate mental health self-assessments and artificial intelligence (AI) in Connected for Wellness to individualize app resources, optimize engagement and recommendations for addressing mental health and social needs; (3) Using a stepped wedge design, test the implementation of the app supported by mental health navigation models (peer navigators, family navigators) for improving connections and access to prevention resources, mental health services and social supports, for youth and families. This project will be initiated with youth 13-22 years old and their family and community members across 10 Los Angeles County Schools and 10 Riverside County/University of California Riverside primary care clinics. A successful outcome of the project is a CPPR developed app-based intervention implementable in school-based and primary care services for access to wellness resources and improving mental health services access along the cascade of care. Outcomes are measured using the cascade of care model with the following key stages: (1) need identification, (2) referral to care/ linkage to resources, and (3) care initiation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In each county, 10 sites will participate (10 high schools in Los Angeles and 10 Primary Care Clinics in Riverside), with sites randomized to cross over from control to intervention status in a step wedged design each Fall following the beginning of the school year. Three months is allowed for training and setup at each site prior to intervention delivery.
| Arm | Type | Receives |
|---|---|---|
| Care as usual | No intervention | –All individuals within each site regardless of type of site or step period will begin with a control period of care as usual Youth and parents within each site will have access to navigators who will share information about mental health and social services supports as well as referrals. The duration of the control period (1, 2, or 3 years; collected via medical and/or other administrative records) will depend on the step period of the individual's site. |
| Implementation | Experimental | Behavioral: Navigator Plus App InterventionIn this stepped wedge design, following a period of care as usual as a control, sites will then cross over to the experimental arm, during which, all youth and their caregivers at the enrolled site are encouraged to download and use the wellness app for the duration of the implementation period. Navigators promote and support use of the app. |
Who may qualify
- Ages
- 13 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Youth 13-22 enrolled in high school or participating primary care clinics, and their caregivers.
Key exclusion criteria (1 listed)
- Those not meeting inclusion criteria
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 |
|---|---|---|
| Navigator Plus App InterventionNavigators will provide their usual care services and also be encouraged to use the Connected for Wellness (CFW) app during their usual activities with youth and caregivers at their site. The duration of this period (2, 3, or 4 years) will depend on the step period of the individual's site. All youth at the school or clinic site can use the CFW app on their own and through the app receive prevention strategies, psycho-education that destigmatizes mental health, encourages referrals to local resources as needed, and increases motivation to access care if needed. | Behavioural | Implementation |
Primary outcome
Proportion of youth referred to mental health services who initiate care.
Time frame: 1 year
Referral to and initiation of mental health services data will be obtained from electronic medical records.
1 secondary outcome
Proportion of youth completing a mental health screening who are referred to care.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Background: PubMed 27476805Cook BL, Trinh NH, Li Z, Hou SS, Progovac AM. Trends in Racial-Ethnic Disparities in Access to Mental Health Care, 2004-2012. Psychiatr Serv. 2017 Jan 1;68(1):9-16. doi: 10.1176/appi.ps.201500453. Epub 2016 Aug 1.
- Background: PubMed 27520100Marrast L, Himmelstein DU, Woolhandler S. Racial and Ethnic Disparities in Mental Health Care for Children and Young Adults: A National Study. Int J Health Serv. 2016 Oct;46(4):810-24. doi: 10.1177/0020731416662736. Epub 2016 Aug 12.
- Background: PubMed 30202195Kataoka SH, Vona P, Acuna A, Jaycox L, Escudero P, Rojas C, Ramirez E, Langley A, Stein BD. Applying a Trauma Informed School Systems Approach: Examples from School Community-Academic Partnerships. Ethn Dis. 2018 Sep 6;28(Suppl 2):417-426. doi: 10.18865/ed.28.S2.417. eCollection 2018.
- Background: PubMed 32989370Arevian AC, Jones F, Moore EM, Goodsmith N, Aguilar-Gaxiola S, Ewing T, Siddiq H, Lester P, Cheung E, Ijadi-Maghsoodi R, Gabrielian S, Sugarman OK, Bonds C, Benitez C, Innes-Gomberg D, Springgate B, Haywood C, Meyers D, Sherin JE, Wells K. Mental Health Community and Health System Issues in COVID-19: Lessons from Academic, Community, Provider and Policy Stakeholders. Ethn Dis. 2020 Sep 24;30(4):695-700. doi: 10.18865/ed.30.4.695. eCollection 2020 Fall.
- Background: PubMed 33779570Balcombe L, De Leo D. Digital Mental Health Challenges and the Horizon Ahead for Solutions. JMIR Ment Health. 2021 Mar 29;8(3):e26811. doi: 10.2196/26811.
- Background: PubMed 36227330Ellis DM, Draheim AA, Anderson PL. Culturally adapted digital mental health interventions for ethnic/racial minorities: A systematic review and meta-analysis. J Consult Clin Psychol. 2022 Oct;90(10):717-733. doi: 10.1037/ccp0000759. Epub 2022 Oct 13.
- Background: PubMed 32478545Fortuna LR, Tolou-Shams M, Robles-Ramamurthy B, Porche MV. Inequity and the disproportionate impact of COVID-19 on communities of color in the United States: The need for a trauma-informed social justice response. Psychol Trauma. 2020 Jul;12(5):443-445. doi: 10.1037/tra0000889. Epub 2020 Jun 1.
- Background: PubMed 29456295Lyon AR, Koerner K. User-Centered Design for Psychosocial Intervention Development and Implementation. Clin Psychol (New York). 2016 Jun;23(2):180-200. doi: 10.1111/cpsp.12154. Epub 2016 Jun 17.
- Background: PubMed 36277565Park SY, Nicksic Sigmon C, Boeldt D. A Framework for the Implementation of Digital Mental Health Interventions: The Importance of Feasibility and Acceptability Research. Cureus. 2022 Sep 19;14(9):e29329. doi: 10.7759/cureus.29329. eCollection 2022 Sep.
- Background: PubMed 35530032Porche MV, Folk JB, Tolou-Shams M, Fortuna LR. Researchers' Perspectives on Digital Mental Health Intervention Co-Design With Marginalized Community Stakeholder Youth and Families. Front Psychiatry. 2022 Apr 22;13:867460. doi: 10.3389/fpsyt.2022.867460. eCollection 2022.
- Derived from this study: PubMed 40857099Fortuna LR, Porche MV, Shumway M, Ijadi-Maghsoodi R, Aralis H, Folk JB, Tolou-Shams M, Barish G, Gonzalez JC, Kataoka S. Addressing Youth Mental Health Through Schools and Primary Care Clinics Using the Connected for Wellness Mobile App: Protocol for a Stepped-Wedge Trial. JMIR Res Protoc. 2025 Aug 26;14:e73721. doi: 10.2196/73721.
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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.
Sheryl Kataoka, MD, MSHS contact
Questions about this trial
What is this clinical trial studying?
A study testing Navigator Plus App Intervention in people with Anxiety and Depression, run by University of California, Riverside.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Fortuna, MD, MPH ((951) 827-0742, lisa.fortuna@medsch.ucr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of youth referred to mental health services who initiate care. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06122688, which also lists 11 linked publications.
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 28 Jan 2026.