NCT06004414 SilverCloud as a School-Based Intervention for Vulnerable Youth
| NCT ID | NCT06004414 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-02-08 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-02-08 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to test the efficacy and feasibility of a clinician-guided, app-based cognitive behavioral therapy (CBT) program, SilverCloud, as a school-based mental health intervention for vulnerable youth. An open trial of SilverCloud will be conducted to determine preliminary efficacy in this sample and inform program refinements by collecting outcome self-report assessments and conducting interviews on feasibility and acceptability. After the program and its implementation strategy are refined, we will conduct an randomized controlled trial. Adolescents who seek or are referred for mental health services through one of the study sites and screen positive for significant mental health symptoms will be randomized to receive SilverCloud or treatment as usual (TAU). Efficacy will be assessed through outcome self-reports. Feasibility and acceptability feedback will again be collected from participants, SBHC staff, and community members.
Eligibility Criteria
Inclusion Criteria: In order to be eligible to participate in the phase I open trial of this study, an individual must meet all of the following criteria: * Enrolled in a high school * Score of 10+ on GAD-7 or PHQ-9 * Speak/read English. The current investigational version of SilverCloud that will be used in this study is only available in English. In order to be eligible to participate in the RCT of this study, an individual must meet all of the following criteria: * Enrolled in 9th through 11th grades. * Score of 10+ on GAD-7 or PHQ-9 * Enrolled in one of the study sites * Speak/read English. The current investigational version of SilverCloud that will be used in this study is only available in English. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in the phase I open trial of this study: * Does not use a smartphone * Mental health concerns for which intensive treatment is indicated. Because SilverCloud has not been evaluated in people with serious mental illness, participants who exhibit symptoms of mania or psychosis will be referred to a higher level of care. * Current suicidal ideation with intent. Participants who have a suicide plan and intent to act on it will be referred to the SBHC suicide risk protocol and will not be eligible until their suicidal thoughts have abated. An individual who meets any of the following criteria will be excluded from participation in the RCT of this study: * Current (within 1 month of enrollment) mental health treatment at one of the study sites * Does not use a smartphone * Mental health concerns for which intensive treatment is indicated. Because SilverCloud has not been evaluated in people with serious mental illness, participants who exhibit symptoms of mania or psychosis will be referred to a higher level of care. * Current suicidal ideation with intent. Participants who have a suicide plan and intent to act on it will be referred for crisis intervention through the site at which they were referred and will not be eligible until their suicidal thoughts have abated.
Contact & Investigator
Anna Van Meter, PhD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06004414 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 22 Years, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06004414 currently recruiting?
Yes, NCT06004414 is actively recruiting participants. Contact the research team at anna.vanmeter@nyulangone.org for enrollment information.
Where is the NCT06004414 trial being conducted?
This trial is being conducted at New Brunswick, United States, Brooklyn, United States, Glen Oaks, United States.
Who is sponsoring the NCT06004414 clinical trial?
NCT06004414 is sponsored by NYU Langone Health. The principal investigator is Anna Van Meter, PhD at NYU Langone Health. The trial plans to enroll 120 participants.
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