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SilverCloud as a School-Based Intervention for Vulnerable Youth

RECRUITINGN/ASponsored by NYU Langone Health
Actively Recruiting
PhaseN/A
SponsorNYU Langone Health
Started2024-02-08
Est. completion2026-08-31
Eligibility
Age13 Years – 22 Years
Healthy vol.Accepted
Locations3 sites

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

Age: 13 Years – 22 YearsHealthy volunteers accepted
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.

Conditions2

AnxietyDepression

Locations3 sites

New Jersey

1 site
Rutgers University
New Brunswick, New Jersey, 08901
Erum Nadeem, Ph.D.

New York

2 sites
NYU Langone Health
Brooklyn, New York, 11220
Northwell Health School Mental Health Partnership sites
Glen Oaks, New York, 11004
Glen Oaks

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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