Clinical trial NCT05018689: Evaluation of the Aevidum Curriculum and Club
Official title: Aevidum: Preliminary Evidence to Showcase a Student-Led Mental Health Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: Mental Health
Adolescents
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: The Hollister Confidence Fund
First posted: 2021-08-24
Enrollment: 2557
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Aim 2: Assess the combination of Aevidum's curriculum AND club activities to improve student perceptions of school culture.

Hypothesis: Exposure to both curriculum and club activities will have the added benefit of improving school environment/stigma and program visibility in addition to knowledge and help-seeking on the Peer-to-Peer Depression Awareness Assessment among the 6 schools assigned to curriculum + club.

In secondary statistical analysis, the curriculum-only schools will be compared to the curriculum plus club activities schools directly.

Specifically: 1) Compare students from schools in Aim 1 (curriculum only) to those in Aim 2 (curriculum plus club) regarding changes in knowledge, help-seeking behavior, school environment/stigma and program visibility.

2) Compare the impact on 9th graders in curriculum schools versus 9th graders in curriculum plus club schools (curriculum will specifically be delivered to 9th grade students at all participating high schools).

Eligibility criteria: Inclusion Criteria:

* Students (in grades 9-12; this is typically ages 14-18 years though a broader span was provided above) and staff from participating schools.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (1 of 4)
timeFrame: baseline (pre-intervention) and post-study completion (an average of 9 months)
measure: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (2 of 4)
timeFrame: baseline (pre-intervention) and post-study completion (an average of 9 months)
measure: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (3 of 4)
timeFrame: baseline (pre-intervention) and post-study completion (an average of 9 months)
measure: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (4 of 4)
timeFrame: baseline (pre-intervention) and post-study completion (an average of 9 months)
measure: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Help-seeking Intentions Scores From Baseline (1 of 3)
timeFrame: baseline (pre-intervention) and post-study completion (an average of 9 months)
measure: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Help-seeking Intentions Scores From Baseline (2 of 3)
timeFrame: baseline (pre-intervention) and post-study completion (an average of 9 months)
measure: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Help-seeking Intentions Scores From Baseline (3 of 3)
timeFrame: baseline assessment (pre-intervention) at the start of the school year and post-assessment after curriculum +/- club delivery (an average of 9 months)
Secondary outcomes:
measure: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (1 of 8)
timeFrame: baseline (pre-intervention) and post-study completion (an average of 9 months)
measure: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (2 of 8)
timeFrame: baseline (pre-intervention) and post-study completion (an average of 9 months)
measure: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (3 of 8)
timeFrame: baseline (pre-intervention) and post-study completion (an average of 9 months)
measure: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (4 of 8)
timeFrame: baseline (pre-intervention) and post-study completion (an average of 9 months)
measure: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (5 of 8)
timeFrame: baseline (pre-intervention) and post-study completion (an average of 9 months)
measure: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (6 of 8)
timeFrame: baseline (pre-intervention) and post-study completion (an average of 9 months)
measure: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (7 of 8)
timeFrame: baseline (pre-intervention) and post-study completion (an average of 9 months)
measure: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (8 of 8)
timeFrame: baseline (pre-intervention) and post-study completion (an average of 9 months)
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
Study officials:
References: