By Youth, For Youth: Digital Supported Peer Navigation for Addressing Child Mental Health Care

NCT06122688 | Not Yet Recruiting DMC

• 1 other identifier: U01MH131827
• Study Type: interventional
• Target: 8,360
• Locations: 0 countries
• Sites: N/A

Brief 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, 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.

Conditions

Anxiety; Depression; Mental Health Issue

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• Proportion of youth completing a mental health screening who are referred to care.

  1 year

Other Outcomes (2)

• Proportion of youth in school/clinic completing a mental health screening.

  1 year

• Proportion of youth initiating mental health services who have 3 or more visits.

  1 year

Study Arms (2)

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.

Behavioral: Navigator Plus App Intervention

Interventions

Navigator Plus App Intervention BEHAVIORAL

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.

Implementation

Eligibility Criteria

• Age: 13 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Youth 13-22 enrolled in high school or participating primary care clinics, and their caregivers.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• University of California, Riverside: lead
• University of California, San Francisco: collaborator
• University of California, Los Angeles: collaborator

Related Publications (11)

• 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.

  PMID: 27476805 BACKGROUND

• Marrast 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.

  PMID: 27520100 BACKGROUND

• Kataoka 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.

  PMID: 30202195 BACKGROUND

• Arevian 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.

  PMID: 32989370 BACKGROUND

• Balcombe 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.

  PMID: 33779570 BACKGROUND

• Ellis 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.

  PMID: 36227330 BACKGROUND

• Fortuna 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.

  PMID: 32478545 BACKGROUND

• Lyon 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.

  PMID: 29456295 BACKGROUND

• Park 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.

  PMID: 36277565 BACKGROUND

• Porche 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.

  PMID: 35530032 BACKGROUND

• Fortuna 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.

  PMID: 40857099 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Lisa Fortuna, MD, MPH

CONTACT

(951) 827-0742; lisa.fortuna@medsch.ucr.edu

Sheryl Kataoka, MD, MSHS

CONTACT

skataoka@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 8, 2023
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: January 28, 2026

Record last verified: 2026-01