SilverCloud as a School-Based Intervention for Vulnerable Youth

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06004414
• Other study ID #: 23-00257
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2024
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: Anna Van Meter, PhD
• Phone: 646-754-5085
• Email: anna.vanmeter[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 screen positive for significant mental health symptoms and who are enrolled in their school-based health center (SBHC) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 22 Years

Eligibility

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 the SBHC at the 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 the SBHC at the high school
• 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:

• Current (within 1 month of enrollment) mental health treatment at the SBHC
• 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 the SBHC
• 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.

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

Behavioral:
• App-based Cognitive Behavioral Therapy (CBT)
SilverCloud is organized into eight core modules that follow evidence-based principles of CBT, along with six additional modules that can be prescribed by the clinician to address a participant's specific needs.
• Psychotherapy
Psychotherapy with a licensed clinician in the school-based health center.

Locations

Country	Name	City	State
United States	NYU Langone Health	Brooklyn	New York
United States	Rutgers University	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Health Questionnaire-9 (PHQ-9) Score	The PHQ-9 is a 9-item questionnaire assessing the degree of depression severity. Items are ranked on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-27; higher scores indicate greater severity of depression.	Baseline, Week 8
Primary	Change in General Anxiety Disorder-7 (GAD-7) Score	The GAD-7 is a 7-item questionnaire assessing the degree of anxiety severity. Items are ranked on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-21; higher scores indicate greater severity of anxiety.	Baseline, Week 8
Secondary	Change in Revised Children's Anxiety and Depression Scale (RCADS-25) Youth Self-Report Score	The RCADS-25 is a self-report questionnaire that assesses symptoms of depression and anxiety in children and adolescents. Each item is rated as 0 (never), 1 (sometimes), 2 (often), or 3 (always). The raw score is the sum of responses and is converted to a T-score where: below 65 = normal range; between 65-69 = borderline clinical range; and 70 above = clinical range.	Baseline, Week 8
Secondary	Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Item Bank v2.0 - Peer Relationships - Short Form 8a Score	This is an 8-item questionnaire assessing pediatric peer relationships. Each item is rated on a scale from 1 (never) to 5 (almost always). A raw score is calculated based on the sum of item responses. The raw score is converted to a T-score ranging from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate stronger peer relationships.	Baseline, Week 8
Secondary	Change in PROMIS Pediatric Item Bank v1.0 - Family Relationships - Short Form 8a	This is an 8-item questionnaire assessing pediatric family relationships. Each item is rated on a scale from 1 (never) to 5 (always). A raw score is calculated based on the sum of item responses. The raw score is converted to a T-score ranging from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate stronger family relationships.	Baseline, Week 8
Secondary	Change in PROMIS Pediatric Item Bank v1.0 - Sleep Disturbance - Short Form 8a	This is an 8-item questionnaire assessing pediatric sleep disturbance. Each item is rated on a scale from 1 (never) to 5 (always). A raw score is calculated based on the sum of item responses. The raw score is converted to a T-score ranging from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate more prevalent sleep disturbance.	Baseline, Week 8
Secondary	Change in School Engagement Scale Score	23-item questionnaire assessing engagement in school. Each item is rated on a 6-point scale ranging from 1-5. The total score is the sum of responses and ranges from 23 to 115. Higher scores indicate greater school engagement.	Baseline, Week 8