SilverCloud as a School-Based Intervention for Vulnerable Youth

NYU Langone Health

Status: Enrolling

Conditions: Depression; Anxiety

Treatments: Behavioral: Psychotherapy; Behavioral: App-based Cognitive Behavioral Therapy (CBT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06004414

23-00257

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 13 to 22 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

SilverCloud

Experimental group

Description:

Adolescents who seek or are referred for mental health services and screen positive for significant mental health symptoms randomized to receive SilverCloud.

Treatment:

Behavioral: App-based Cognitive Behavioral Therapy (CBT)

Treatment as Usual (TAU)

Active Comparator group

Description:

Adolescents who seek or are referred for mental health services and screen positive for significant mental health symptoms randomized to receive psychotherapy.

Treatment:

Behavioral: Psychotherapy