Using an app-based therapy program in schools for at-risk youth
Hybrid Type I Effectiveness-implementation Trial of SilverCloud as a School-based Intervention for Vulnerable Youth
This study is testing whether a mental health app can help high school students with depression and anxiety feel better compared to regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 13 Years to 22 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 3 sites (New Brunswick, New Jersey and 2 other locations) |
| Trial ID | NCT06004414 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and feasibility of SilverCloud, a clinician-guided app-based cognitive behavioral therapy (CBT) program, as a mental health intervention for vulnerable adolescents in school settings. Initially, an open trial will assess its preliminary efficacy and gather feedback on its implementation from participants and staff. Following this, a randomized controlled trial will compare the outcomes of students receiving SilverCloud to those receiving standard treatment. The study focuses on high school students who exhibit significant symptoms of depression and anxiety.
Who should consider this trial
Good fit: Ideal candidates are high school students in grades 9 to 11 who score 10 or higher on anxiety or depression screening tools and can read and speak English.
Not a fit: Patients with severe mental health issues requiring intensive treatment or those who do not use smartphones may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide accessible mental health support to at-risk youth, improving their emotional well-being.
How similar studies have performed: Other studies have shown promise in using app-based therapies for mental health, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Brunswick, New Jersey and 2 other locations
- Rutgers University — New Brunswick, New Jersey, United States (Not_yet_recruiting)
- NYU Langone Health — Brooklyn, New York, United States (Recruiting)
- Northwell Health School Mental Health Partnership sites — Glen Oaks, New York, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Anna Van Meter, PhD — NYU Langone Health
- Study coordinator: Anna Van Meter, PhD
- Email: anna.vanmeter@nyulangone.org
- Phone: 646-754-5085
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.