Clinical trial NCT06004414: SilverCloud as a School-Based Intervention for Vulnerable Youth
Official title: Hybrid Type I Effectiveness-implementation Trial of SilverCloud as a School-based Intervention for Vulnerable Youth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Keywords: depression
anxiety
behavioral therapy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-08-22
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


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.

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score
timeFrame: Baseline, Week 8
measure: Change in General Anxiety Disorder-7 (GAD-7) Score
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change in Revised Children's Anxiety and Depression Scale (RCADS-25) Youth Self-Report Score
timeFrame: Baseline, Week 8
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Item Bank v2.0 - Peer Relationships - Short Form 8a Score
timeFrame: Baseline, Week 8
measure: Change in PROMIS Pediatric Item Bank v1.0 - Family Relationships - Short Form 8a
timeFrame: Baseline, Week 8
measure: Change in PROMIS Pediatric Item Bank v1.0 - Sleep Disturbance - Short Form 8a
timeFrame: Baseline, Week 8
measure: Change in School Engagement Scale Score
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
city: Brooklyn
country: United States
facility: NYU Langone Health
state: New York
city: Glen Oaks
country: United States
facility: Northwell Health School Mental Health Partnership sites
state: New York
Study officials:
affiliation: NYU Langone Health
name: Anna Van Meter, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers University
name: Erum Nadeem, PhD
role: PRINCIPAL_INVESTIGATOR
References: