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Official title SilverCloud as a School-Based Intervention for Vulnerable Youth
ClinicalTrials.gov ID: NCT06004414
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 22
You may be able to join 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...
- Enrolled in 9th through 11th grades.
You likely can't join 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...
- 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...
- Current (within 1 month of enrollment) mental health treatment at one of the study sites
- Does not use a smartphone
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- New Brunswick, New Jersey, United States
- Brooklyn, New York, United States
- Glen Oaks, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 22 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Brunswick, New Jersey, United States; Brooklyn, New York, United States; Glen Oaks, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.