SilverCloud as a School-Based Intervention for Vulnerable Youth

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Change in Patient Health Questionnaire-9 (PHQ-9) Score [Срок оценки: Baseline, Week 8]
• Change in General Anxiety Disorder-7 (GAD-7) Score [Срок оценки: Baseline, Week 8]

Вторичные конечные точки (5)

• Change in Revised Children's Anxiety and Depression Scale (RCADS-25) Youth Self-Report Score [Срок оценки: Baseline, Week 8]
• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Item Bank v2.0 - Peer Relationships - Short Form 8a Score [Срок оценки: Baseline, Week 8]
• Change in PROMIS Pediatric Item Bank v1.0 - Family Relationships - Short Form 8a [Срок оценки: Baseline, Week 8]
• Change in PROMIS Pediatric Item Bank v1.0 - Sleep Disturbance - Short Form 8a [Срок оценки: Baseline, Week 8]
• Change in School Engagement Scale Score [Срок оценки: Baseline, Week 8]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 3 центра

• Rutgers University — New Brunswick
• NYU Langone Health — Brooklyn
• Northwell Health School Mental Health Partnership sites — Glen Oaks

Идентификаторы

NCT: NCT06004414 · 23-00257

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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