Aevidum: Preliminary Evidence to Showcase a Student-Led Mental Health Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,557
- 试验地点
- 2
- 主要终点
- Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (1 of 4)
研究概览
简要总结
The study purpose is to evaluate the effectiveness of the Aevidum curriculum (plus/minus club) to improve adolescent mental health knowledge, help-seeking intentions, and school culture. Investigators will partner with 12 high schools for this study. Prior to the start of the 2021-2022 academic year, schools will be recruited and randomly assigned to implement the Aevidum curriculum (n=6) or the curriculum and club (n=6). Please note, ultimately a total of 10 schools were recruited, with 5 assigned to each arm.
详细描述
Aevidum was established in 2009 as a student-led initiative to raise awareness and reduce the stigma surrounding mental illness. Their mental health curriculum and club activities are currently used in over 300 schools in Pennsylvania and surrounding states. In comparison to current interventions, Aevidum is unique in that it provides students the opportunity to build a strong support system among peers. Aevidum's curriculum and club activities provide an opportunity for schools and students to engage with mental health and suicide prevention materials with a student-directed method. Youth voice is a powerful tool that schools and communities can utilize to make mental health and suicide prevention programming more impactful. Allowing youth the chance to lead and let their voices be heard can create greater buy-in for activities.
At present, there is not a strong evidence-base for the efficacy of student-led initiatives that aid in reaching mandated Act 71 curriculum standards for mental health and suicide prevention. Aevidum lacks an evidence-base for its curriculum and club programming, which is freely available to schools. To continue offering free resources, while also maintaining and updating these resources to ensure they are innovative and best reflect student needs, Aevidum needs to establish an evidence-base to support future funding. This project plans to evaluate the effectiveness of these efforts in supporting adolescent mental health. Results will be used to inform school-based mental health programming and to establish an evidence-base for the Aevidum program, furthering mental health awareness and education, while also reducing mental health stigma.
While set up as a randomized clinical trial, this portion of the study is largely exploratory and has not be formally powered. Knowledge, help-seeking, school environment/stigma and program visibility will be assessed both in a pre/post assessment and compared between study arms as follows:
Aim 1: Assess Aevidum's curriculum in improving students' mental health knowledge and help-seeking intentions.
Hypothesis: Exposure to Aevidum's five module mental health curriculum will result in significant improvements in knowledge and help seeking intentions between pre- and post-survey measures using the published University of Michigan Depression Center (UMDC) Peer-to-Peer Depression Awareness Assessment among the 6 schools assigned to curriculum only.
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
- None
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Students (in grades 9-12; this is typically ages 14-18 years though a broader span was provided above) and staff from participating schools.
排除标准
- •Students not enrolled in one of the participating high schools (n=12)
- •Students not in grades 9-12
- •Students with disabilities that are deemed unable to participate by the school district
- •Non-English speaking students as curriculum and club materials are taught/available in English only at this time
结局指标
主要结局
Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (1 of 4)
时间窗: baseline (pre-intervention) and post-study completion (an average of 9 months)
This will be assessed using the University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment: baseline assessment (pre-intervention) at the start of the school year and post-assessment after curriculum +/- club delivery (an average of 9 months) Response options: 1 Not at all confident, 2-4 Moderately confident, 5-7 Extremely confident Results provided in the outcome measure data table include difference of mean score from pre to post test (95% CI) in each study arm. Statistical analyses include p-values from a mixed effects linear regression model.
Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (2 of 4)
时间窗: baseline (pre-intervention) and post-study completion (an average of 9 months)
This will be assessed using the University of Michigan Depression Center (UMDC) Peer-to-Peer Depression Awareness Assessment: baseline assessment (pre-intervention) at the start of the school year and post-assessment after curriculum +/- club delivery (an average of 9 months) Question: If your friend tells you that he/she is thinking about suicide and asks you to keep it a secret because no one else knows, what do you do? Responses are tell someone (correct) or keep it a secret (incorrect). Results provided in the outcome measure data table include odds of a correct response from pre to post test reported in each study arm as odds ratio (95% CI). Statistical analysis includes the p-value from a mixed effects logistic regression model.
Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (3 of 4)
时间窗: baseline (pre-intervention) and post-study completion (an average of 9 months)
This will be assessed using the University of Michigan Depression Center (UMDC) Peer-to-Peer Depression Awareness Assessment: baseline assessment (pre-intervention) at the start of the school year and post-assessment after curriculum +/- club delivery (an average of 9 months) All responses in this section were true or false. The correct answer (i.e., true or false) to each items is included in the row description below. Results provided in the outcome measure data table include odds of a correct response from pre to post test reported in each study arm as odds ratio (95% CI). Statistical analyses include p-values from a mixed effects logistic regression model.
Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (4 of 4)
时间窗: baseline (pre-intervention) and post-study completion (an average of 9 months)
This will be assessed using the University of Michigan Depression Center (UMDC) Peer-to-Peer Depression Awareness Assessment: baseline assessment (pre-intervention) at the start of the school year and post-assessment after curriculum +/- club delivery (an average of 9 months) The questions in this section asked students to correctly identify these symptoms of depression (dichotomous responses) Results provided in the outcome measure data table include odds of a correct response from pre to post test reported in each study arm as odds ratio (95% CI). Statistical analyses include p-values from a mixed effects logistic regression model.
Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Help-seeking Intentions Scores From Baseline (1 of 3)
时间窗: baseline (pre-intervention) and post-study completion (an average of 9 months)
This will be assessed using the University of Michigan Depression Center (UMDC) Peer-to-Peer Depression Awareness Assessment: baseline assessment (pre-intervention) at the start of the school year and post-assessment after curriculum +/- club delivery (an average of 9 months) Question: If you thought that you had depression, how likely is it that you would seek help from the following people or places? Response options: 1 (Not at all likely), 2 (Not too likely), 3 (Somewhat likely), 4 (Very likely) Results provided in the outcome measure data table include difference of mean score from pre to post test (95% CI) in each study arm. Statistical analyses include p-values from a mixed effects linear regression model.
Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Help-seeking Intentions Scores From Baseline (2 of 3)
时间窗: baseline (pre-intervention) and post-study completion (an average of 9 months)
This will be assessed using the University of Michigan Depression Center (UMDC) Peer-to-Peer Depression Awareness Assessment: baseline assessment (pre-intervention) at the start of the school year and post-assessment after curriculum +/- club delivery (an average of 9 months) Response options yes or no, with preferred answer being "yes" for both items Results provided in the outcome measure data table include odds of a correct response from pre to post test reported in each study arm as odds ratio (95% CI). Statistical analyses include p-values from a mixed effects logistic regression model.
Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Help-seeking Intentions Scores From Baseline (3 of 3)
时间窗: baseline assessment (pre-intervention) at the start of the school year and post-assessment after curriculum +/- club delivery (an average of 9 months)
This will be assessed using the University of Michigan Depression Center (UMDC) Peer-to-Peer Depression Awareness Assessment: baseline assessment (pre-intervention) at the start of the school year and post-assessment after curriculum +/- club delivery (an average of 9 months) Question: Do you know how to get help in your school? Response options: 1 (Not really), 2 (Sort of), 3 (Definitely) Results provided in the outcome measure data table include difference of mean score from pre to post test (95% CI) in each study arm. Statistical analysis includes the p-value from a mixed effects linear regression model.
次要结局
- Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (8 of 8)(baseline (pre-intervention) and post-study completion (an average of 9 months))
- Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (1 of 8)(baseline (pre-intervention) and post-study completion (an average of 9 months))
- Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (2 of 8)(baseline (pre-intervention) and post-study completion (an average of 9 months))
- Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (3 of 8)(baseline (pre-intervention) and post-study completion (an average of 9 months))
- Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (4 of 8)(baseline (pre-intervention) and post-study completion (an average of 9 months))
- Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (5 of 8)(baseline (pre-intervention) and post-study completion (an average of 9 months))
- Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (6 of 8)(baseline (pre-intervention) and post-study completion (an average of 9 months))
- Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (7 of 8)(baseline (pre-intervention) and post-study completion (an average of 9 months))
研究者
Deepa Sekhar
Associate Professor, Department of Pediatrics
Milton S. Hershey Medical Center