SilverCloud as a School-Based Intervention for Vulnerable Youth

Description

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

Study Overview

Study Details

Study overview

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.

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

SilverCloud as a School-Based Intervention for Vulnerable Youth

Condition
Depression
Intervention / Treatment

-

Contacts and Locations

New Brunswick

Rutgers University, New Brunswick, New Jersey, United States, 08901

Brooklyn

NYU Langone Health, Brooklyn, New York, United States, 11220

Glen Oaks

Northwell Health School Mental Health Partnership sites, Glen Oaks, New York, United States, 11004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.
  • * 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.
  • * 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.

Ages Eligible for Study

13 Years to 22 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NYU Langone Health,

Anna Van Meter, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Erum Nadeem, PhD, PRINCIPAL_INVESTIGATOR, Rutgers University

Study Record Dates

2027-01