RecruitingNot ApplicableNCT06004414

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

Sponsor

NYU Langone Health

Enrollment

120 participants

Start Date

Feb 8, 2024

Study Type

INTERVENTIONAL

Conditions

Depression Anxiety

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

Min Age: 13 YearsMax Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a digital mental health app called SilverCloud can help high school students who are experiencing anxiety or depression symptoms. **You may be eligible if:** - You are a high school student (grades 9–11 for the main trial) - You score 10 or higher on a standard anxiety (GAD-7) or depression (PHQ-9) screening questionnaire - You read and speak English - You have a smartphone **You may NOT be eligible if:** - You have serious mental illness symptoms such as mania or psychosis - You have active thoughts of suicide with a plan and intent to act - You are currently receiving mental health treatment at the study school (for the randomized part of the trial) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.