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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
13 Years to 22 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests SilverCloud, a mental health app used with guidance from a clinician, for high school students with significant anxiety or depression symptoms. It uses cognitive behavioral therapy (CBT), which helps people work on thoughts and behaviors. The study will test how well the program works in schools, first on its own and then compared with usual care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • First phase: Be enrolled in high school.
  • Later comparison phase: Be in 9th through 11th grade and enrolled at a study site.
  • Both phases: Score 10 or higher on either the GAD-7 anxiety survey or the PHQ-9 depression survey.
  • Both phases: Speak and read English, since the study app is only available in English.

Who can't join

  • Both phases: Do not use a smartphone.
  • Both phases: Need more intensive mental health treatment, including for mania (extreme high energy or mood) or psychosis (trouble knowing what is real).
  • Both phases: Have current thoughts of suicide with intent to act. Students with a suicide plan and intent will be referred for crisis help and cannot join until these thoughts have eased.
  • Later comparison phase only: Have received mental health treatment at a study site within 1 month of enrollment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 English. The current investigational version of SilverCloud that will be used in this study is only available in English. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in the phase I open trial of this study: * Does not use a smartphone * Mental health concerns for which intensive treatment is indicated. Because SilverCloud has not been evaluated in people with serious mental illness, participants who exhibit symptoms of mania or psychosis will be referred to a higher level of care. * Current suicidal ideation with intent. Participants who have a suicide plan and intent to act on it will be referred to the SBHC suicide risk protocol and will not be eligible until their suicidal thoughts have abated. An individual who meets any of the following criteria will be excluded from participation in the RCT of this study: * Current (within 1 month of enrollment) mental health treatment at one of the study sites * Does not use a smartphone * Mental health concerns for which intensive treatment is indicated. Because SilverCloud has not been evaluated in people with serious mental illness, participants who exhibit symptoms of mania or psychosis will be referred to a higher level of care. * Current suicidal ideation with intent. Participants who have a suicide plan and intent to act on it will be referred for crisis intervention through the site at which they were referred and will not be eligible until their suicidal thoughts have abated.

Study sites (3)

NJ

NY