SilverCloud as a School-Based Intervention for Vulnerable Youth

NCT06004414 | Recruiting

• 1 other identifier: 23-00257
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Depression; Anxiety

Keywords

depression; anxiety; behavioral therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Change in Revised Children's Anxiety and Depression Scale (RCADS-25) Youth Self-Report Score

  Baseline, Week 8

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Item Bank v2.0 - Peer Relationships - Short Form 8a Score

  Baseline, Week 8

• Change in PROMIS Pediatric Item Bank v1.0 - Family Relationships - Short Form 8a

  Baseline, Week 8

• Change in PROMIS Pediatric Item Bank v1.0 - Sleep Disturbance - Short Form 8a

  Baseline, Week 8

• Change in School Engagement Scale Score

  Baseline, Week 8

Study Arms (2)

SilverCloud

EXPERIMENTAL

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

Behavioral: App-based Cognitive Behavioral Therapy (CBT)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Behavioral: Psychotherapy

Interventions

App-based Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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.

Also known as: SilverCloud

SilverCloud

Psychotherapy BEHAVIORAL

Psychotherapy with a licensed clinician at one of the study sites.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 13 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Rutgers University

New Brunswick, New Jersey, 08901, United States

NOT YET RECRUITING

NYU Langone Health

Brooklyn, New York, 11220, United States

RECRUITING

Northwell Health School Mental Health Partnership sites

Glen Oaks, New York, 11004, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Anna Van Meter, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Erum Nadeem, PhD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Van Meter, PhD

CONTACT

646-754-5085; anna.vanmeter@nyulangone.org

Erum Nadeem, PhD

CONTACT

Erum.nadeem@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 22, 2023
• Study Start: February 8, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by the NIMH Data Archive will be shared to achieve aims in the approved proposal. Data are available indefinitely through the NIMH Data Archive.

Locations

US (3)