NCT Number: NCT06004414
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.
Interested in participating?
Request Info13 year–22 year
All sexes
Interventional
Not applicable
Rutgers University, New Brunswick, New Jersey, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
In order to be eligible to participate in the RCT of this study, an individual must meet all of the following criteria:
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:
An individual who meets any of the following criteria will be excluded from participation in the RCT of this study:
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.
Other names: SilverCloud
Psychotherapy with a licensed clinician at one of the study sites.
Time frame: Baseline, Week 8
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.
Time frame: Baseline, Week 8
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.
Time frame: Baseline, Week 8
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.
Time frame: Baseline, Week 8
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.
Time frame: Baseline, Week 8
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.
Time frame: Baseline, Week 8
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.
Time frame: Baseline, Week 8
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.
Contact information is provided by the study sponsor or research team.
Anna Van Meter, PhD
CONTACT
Erum Nadeem, PhD
CONTACT
NYU Langone Health
Other
Hybrid Type I Effectiveness-implementation Trial of SilverCloud as a School-based Intervention for Vulnerable Youth
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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