SilverCloud as a School-Based Intervention for Vulnerable Youth

Conditions

• Anxiety
• Depression

Eligibility Criteria

Sex

ALL

Age

13 Years - 22 Years

Healthy Volunteers

Not accepted

Interventions

• App-based Cognitive Behavioral Therapy (CBT) — BEHAVIORAL
  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.
• Psychotherapy — BEHAVIORAL
  Psychotherapy with a licensed clinician at one of the study sites.

Study Details

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.

Key Dates

Start date

Feb 8, 2024

Status verified

Mar 2026

Primary completion

Dec 31, 2026

Completion

Jun 30, 2027

Study Design

Enrollment

120 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: SilverCloud
  Adolescents who seek or are referred for mental health services and screen positive for significant mental health symptoms randomized to receive SilverCloud.
• Active Comparator: Treatment as Usual (TAU)
  Adolescents who seek or are referred for mental health services and screen positive for significant mental health symptoms randomized to receive psychotherapy.

Primary Outcome Measure

Change in Patient Health Questionnaire-9 (PHQ-9) Score [ Time Frame: Baseline, Week 8 ]

Central Contacts

• Anna Van Meter, PhD
  646-754-5085
  [email protected]
• Erum Nadeem, PhD
  [email protected]

Locations (3)

Find similar trials in New Brunswick, NJ

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