Evaluation of the Aevidum Curriculum and Club

NCT ID: NCT05018689

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2557 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-05-25

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).

Conditions

Mental Health Wellness 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Aevidum curriculum

Curriculum: Aevidum has developed a 5-lesson 3-hour mental health curriculum that can be broken up and integrated into existing school health curricula. The study team in partnership with the Executive Director of Aevidum will collaborate with schools to implement the curriculum to their 9th grade students.

Group Type: ACTIVE_COMPARATOR

Aevidum curriculum

Intervention Type: OTHER

The Aevidum curriculum will be delivered to 9th grade students at participating high schools in both study arms. All school staff who plan to deliver the curriculum will participate in a web-based training workshop with the Aevidum Executive Director.

Aevidum curriculum + club

Curriculum + club. Schools assigned to the curriculum plus club will also start an Aevidum club at their school. Club basic processes and ideas for events are housed on the Aevidum website. Schools will select faculty and student leaders who will participate in a kickoff web-based training at the start of the academic year. The training is led by current Aevidum student leaders at schools with successful clubs. This is a standard orientation process that Aevidum has run for many years in-person, but has been adapted to a virtual format with the COVID-19 pandemic.

Group Type: ACTIVE_COMPARATOR

Aevidum curriculum

Intervention Type: OTHER

The Aevidum curriculum will be delivered to 9th grade students at participating high schools in both study arms. All school staff who plan to deliver the curriculum will participate in a web-based training workshop with the Aevidum Executive Director.

Club

Intervention Type: OTHER

Schools will identify ten students interested in participating in an Aevidum club. Following training of interested students, schools are asked to commit to running two Aevidum club activities during the school year.

Interventions

Aevidum curriculum

The Aevidum curriculum will be delivered to 9th grade students at participating high schools in both study arms. All school staff who plan to deliver the curriculum will participate in a web-based training workshop with the Aevidum Executive Director.

Intervention Type: OTHER

Club

Schools will identify ten students interested in participating in an Aevidum club. Following training of interested students, schools are asked to commit to running two Aevidum club activities during the school year.

Intervention Type: OTHER

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hollister Confidence Fund

OTHER

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Deepa Sekhar

Associate Professor, Department of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Penn State College of Medicine

Hershey, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00017706

Identifier Type: -

Identifier Source: org_study_id