Back to resultsSilverCloud as a School-Based Intervention for Vulnerable Youth
Primary Purpose
Depression, Anxiety
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
App-based Cognitive Behavioral Therapy (CBT)
Psychotherapy
Sponsored by
About this trial
This is an interventional health services research trial for Depression focused on measuring depression, anxiety, behavioral therapy
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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SilverCloud
Treatment as Usual (TAU)
Arm Description
Adolescents who screen positive for significant mental health symptoms and who are enrolled in their school-based health center (SBHC) randomized to receive SilverCloud.
Adolescents who screen positive for significant mental health symptoms and who are enrolled in their school-based health center (SBHC) randomized to receive psychotherapy.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT06004414
First Posted
August 17, 2023
Last Updated
August 17, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT06004414
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
depression, anxiety, behavioral therapy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SilverCloud
Arm Type
Experimental
Arm Description
Adolescents who screen positive for significant mental health symptoms and who are enrolled in their school-based health center (SBHC) randomized to receive SilverCloud.
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
Adolescents who screen positive for significant mental health symptoms and who are enrolled in their school-based health center (SBHC) randomized to receive psychotherapy.
Intervention Type
Behavioral
Intervention Name(s)
App-based Cognitive Behavioral Therapy (CBT)
Other Intervention Name(s)
SilverCloud
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
Psychotherapy with a licensed clinician in the school-based health center.
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Description
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
Title
Change in General Anxiety Disorder-7 (GAD-7) Score
Description
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
Secondary Outcome Measure Information:
Title
Change in Revised Children's Anxiety and Depression Scale (RCADS-25) Youth Self-Report Score
Description
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
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Item Bank v2.0 - Peer Relationships - Short Form 8a Score
Description
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
Title
Change in PROMIS Pediatric Item Bank v1.0 - Family Relationships - Short Form 8a
Description
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
Title
Change in PROMIS Pediatric Item Bank v1.0 - Sleep Disturbance - Short Form 8a
Description
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
Title
Change in School Engagement Scale Score
Description
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.
Time Frame
Baseline, Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Van Meter, PhD
Phone
646-754-5085
Email
anna.vanmeter@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Erum Nadeem, PhD
Email
Erum.nadeem@rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Van Meter, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erum Nadeem, PhD
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared with investigators whose proposed use of the data has been approved by the NIMH Data Archive. Data will be made available following article publication or as required by a condition of awards and agreements supporting the research. Data are available indefinitely through the NIMH Data Archive. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing 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.
Learn more about this trial
SilverCloud as a School-Based Intervention for Vulnerable Youth
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