- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06122688
By Youth, For Youth: Digital Supported Peer Navigation for Addressing Child Mental Health Inequities
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lisa Fortuna, MD, MPH
- Phone Number: (951) 827-0742
- Email: lisa.fortuna@medsch.ucr.edu
Study Contact Backup
- Name: Sheryl Kataoka, MD, MSHS
- Email: skataoka@mednet.ucla.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Youth 13-22 enrolled in high school or participating primary care clinics, and their caregivers.
Exclusion Criteria:
- Those not meeting inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Care as usual
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. |
|
Experimental: Implementation
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of youth completing a mental health screening who are referred to care.
Time Frame: 1 year
|
Mental health screening and referral to mental health services data will be obtained from electronic medical records.
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of youth in school/clinic completing a mental health screening.
Time Frame: 1 year
|
Mental health screening data will be obtained from electronic medical records.
|
1 year
|
Proportion of youth initiating mental health services who have 3 or more visits.
Time Frame: 1 year
|
Mental health initiation and visit data will be obtained from electronic medical records.
|
1 year
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U01MH131827 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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