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SilverCloud as a School-Based Intervention for Vulnerable Youth

NCT06004414 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Anna Van Meter, PhD · NYU Langone Health

  • Erum Nadeem, PhD · Rutgers University

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-08
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06004414 on ClinicalTrials.gov