NCT06004414

SilverCloud as a School-Based Intervention for Vulnerable Youth

Hybrid Type I Effectiveness-implementation Trial of SilverCloud as a School-based Intervention for Vulnerable Youth

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 13 Years – 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression
• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	App-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.
BEHAVIORAL	Psychotherapy	Psychotherapy with a licensed clinician at one of the study sites.

Timeline

• Start date: 2024-02-08
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2023-08-22
• Last updated: 2026-03-30

Locations

3 sites across 1 country: United States