Project SOLVE: A School-based Trial of a Universal Single-session Digital Problem-solving Intervention for Adolescent Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 522
- 试验地点
- 2
- 主要终点
- Change in State Hope Scale Pathways Subscale From Immediately Pre-Intervention to Immediately Post-Intervention
研究概览
简要总结
The goal of this trial is to examine the effectiveness of a universal, self-guided, digital single-session intervention focusing on problem-solving skills in improving adolescent mental health and well-being, relative to an active control intervention focusing on study skills, within the context of school settings during the coronavirus disease pandemic.
详细描述
More than 20% of adolescents will experience at least one mental health disorder or problem before adulthood that warrants treatment, yet 80% of these adolescents will never receive care. This need-to-access gap appears to be heightened during the current coronavirus disease pandemic and its resulting disruptions to healthcare and education systems. Both within and beyond the context of the pandemic, preventive mental health interventions are positioned to help adolescents build and strengthen coping strategies that can preclude the emergence of mental health difficulties that require more resource-intensive levels of clinical care. Preventive mental health interventions delivered via digital platforms and within school-based settings might be especially scalable.
The current school-based trial is designed to test one such strategy that harnesses technology to boost the scalability of adolescent mental health interventions: a brief (one 30 minute session) digital program designed to empower adolescents (10-14 years old) to solve, rather than be overwhelmed by, everyday problems (Project SOLVE). Single-session interventions designed to help adolescents cultivate adaptive mindsets have reduced anxiety and depression among adolescents with and without elevated symptoms of these disorders. Building on this strong foundation, Project SOLVE targets these mental health challenges with problem solving skills-one of the most versatile, commonly used, and potent therapeutic techniques for adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescent is in grades 6-8 (inclusive) at partnering schools
- •Adolescent is between the ages of 10-14 years (inclusive) at the time of study enrollment
- •Adolescent and at least one guardian consent to adolescent participation in study
- •Adolescent reads English well enough to effectively complete the digital programs
- •Adolescent has access to a digital device
排除标准
- •Adolescent is non-English speaking, as the programs are only available in English
- •Adolescent does not have access to a digital device
- •Adolescent has an intellectual disability that precludes comprehension of the program content
结局指标
主要结局
Change in State Hope Scale Pathways Subscale From Immediately Pre-Intervention to Immediately Post-Intervention
时间窗: Immediately pre-intervention to immediately post-intervention
Change in self-reported hopefulness, as measured via the 3-item "pathways" (planning of ways to meet goals) subscale of the State Hope Scale. Each item is rated on a 1-8 scale and total scores range from 1 to 24, with higher scores indicating higher levels of hopefulness.
Change in Behavior and Feelings Survey (Internalizing Subscale) From Baseline to 12-month Follow-Up
时间窗: Baseline to 12-month follow-up
Trajectories of self-reported symptoms of anxiety and depression from the 6-item (each item rated on a 0-4 scale, with higher ratings indicating more symptoms) Internalizing subscale of the Behavior and Feelings Survey. Total scores range from 0 to 24, with higher scores indicating more symptoms.
Change in Behavior and Feelings Survey (Internalizing Subscale) From Baseline to 3-month Follow-Up
时间窗: Baseline to 3-month follow-up
Trajectories of self-reported symptoms of anxiety and depression from the 6-item (each item rated on a 0-4 scale, with higher ratings indicating more symptoms) Internalizing subscale of the Behavior and Feelings Survey. Total scores range from 0 to 24, with higher scores indicating more symptoms.
Change in Beck Hopelessness Scale From Immediately Pre-Intervention to Immediately Post-Intervention
时间窗: Immediately pre-intervention to immediately post-intervention
The Beck Hopelessness Scale (BHS) asks adolescents to rate 4 statements based on their sense of hopelessness. Participants rate the 4 statements on a 4 point scale ranging from 0 (Absolutely Disagree) to 3 (Absolutely Agree). Total score ranges from 0 to 12, with higher scores indicating greater levels of hopelessness.
次要结局
- Change in Beck Hopelessness Scale From Baseline to 12-Month Follow-Up(Baseline to 12-month follow-up)
- Change in State Hope Scale From Baseline to 3-Month Follow-Up(Baseline to 3-month follow-up)
- Perceived Program Acceptability and Helpfulness(Immediately post-intervention)
- Change in Behavior and Feelings Survey (Externalizing Subscale) From Baseline to 12-month Follow-Up(Baseline to 12-month follow-up)
- Change in Behavior and Feelings Survey (Externalizing Subscale) From Baseline to 3-month Follow-Up(Baseline to 3-month follow-up)
- Change in State Hope Scale From Baseline to 12-Month Follow-Up(Baseline to 12-month follow-up)
- Change in Beck Hopelessness Scale From Baseline to 3-Month Follow-Up(Baseline to 3-month follow-up)
研究者
Olivia Fitzpatrick
Principal Investigator; Doctoral Student
Harvard University