Using an app-based therapy program in schools for at-risk youth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• NYU Langone Health
  Brooklyn, New York, United States Recruiting
• Rutgers University
  New Brunswick, New Jersey, United States Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.