Hybrid Type I Effectiveness-implementation Trial of SilverCloud as a School-based Intervention for Vulnerable Youth
NYU Langone Health
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 range
- 13–22 years
- Sex
- All
- Healthy volunteers
- No
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 Eng…
Interventions
- BehavioralApp-based Cognitive Behavioral Therapy (CBT)
SilverCloud is organized into eight core modules that follow evidence-based principles of CBT, along with six additional modules that can be prescribed by the clinician to address a participant's specific needs.
- BehavioralPsychotherapy
Psychotherapy with a licensed clinician at one of the study sites.
Locations (3)
- Rutgers UniversityNew Brunswick, New Jersey
- NYU Langone HealthBrooklyn, New York
- Northwell Health School Mental Health Partnership sitesGlen Oaks, New York