Mental Health Wellness 1NCT05018689

Evaluation of the Aevidum Curriculum and Club

A study testing Aevidum curriculum and Club in people with Mental Health Wellness 1, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 13 to 21 years
Conditions the study is for: Mental Health Wellness 1
What is being tested?: Aevidum curriculum and Club
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,557 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2021to 25 May 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Penn State College of Medicine
Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: Aevidum: Preliminary Evidence to Showcase a Student-Led Mental Health Program

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.

Read the 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.

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
Being tested: Aevidum curriculum, Club
Keywords: Mental Health, Adolescents
Medical subject headings: Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aevidum curriculumOther
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.
ClubOther
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.

Study groups in NCT05018689
Study group	Role	What they receive
Aevidum curriculum	Active comparator	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. Receives: Other: Aevidum curriculum
Aevidum curriculum + club	Active comparator	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. Receives: Other: Aevidum curriculum; Other: Club

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (1 of 4)
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.
Measured: 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 Knowledge Scores From Baseline (2 of 4)
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.
Measured: 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 Knowledge Scores From Baseline (3 of 4)
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.
Measured: 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 Knowledge Scores From Baseline (4 of 4)
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.
Measured: 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 Help-seeking Intentions Scores From Baseline (1 of 3)
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.
Measured: 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 Help-seeking Intentions Scores From Baseline (2 of 3)
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.
Measured: 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 Help-seeking Intentions Scores From Baseline (3 of 3)
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.
Measured: 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 (8)

Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (1 of 8)
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: Imagine that you recently heard about a new student at your school who has depression. To what extent do you agree or disagree with the following statements? Response options: 1 (strongly disagree), 2 (disagree), 3 (neither agree nor disagree), 4 (agree), 5 (strongly agree)
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.
Measured: 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)
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: On a scale from 1 to 7, if you were seen going into the office of your school social worker or school psychologist, how would you feel? Response options: 1 (Not at all embarrassed), 2, 3, 4 (Moderately embarrassed), 5, 6, 7 (Extremely embarrassed)
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.
Measured: 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)
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: How comfortable are you talking about mental health issues with other students at your school? Response options: 1 (Not at all comfortable), 2, 3, 4 (Moderately comfortable), 5, 6, 7 (Extremely comfortable)
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.
Measured: 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)
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: What mental health issues do you think are most concerning to other students at your school? Response options: dichotomous response for each listed mental health issue in rows 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.
Measured: 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)
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: 1 (A little), 2 (some), 3 (A lot)
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.
Measured: 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)
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: How would you like your school to show that they care about student mental health? Response options: dichotomous for each item listed 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.
Measured: 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)
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: On average, how often do your teachers speak to you about your emotions and feelings? Response options: 1 (daily), 2 (weekly), 3 (monthly), 4 (never)
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.
Measured: 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 (8 of 8)
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: Would you like your teachers to speak to you about your emotions and feelings? Response options: 1 (yes), 2 (maybe), 3 (no)
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.
Measured: baseline (pre-intervention) and post-study completion (an average of 9 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202125 May 2022

First posted24 Aug 2021
Study start1 Sep 2021
Primary completion25 May 2022
Study completion25 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2,557 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05018689
Sponsor's protocol ID: STUDY00017706
Status last verified: Jul 2024
First submitted: 13 Aug 2021
Last updated: 18 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Mental Health Wellness 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Aevidum: Preliminary Evidence to Showcase a Student-Led Mental Health Program
ClinicalTrials.gov ID: NCT05018689
Acronym / sponsor ID: STUDY00017706
Conditions: Mental Health Wellness 1
Keywords: Mental Health, Adolescents
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,557 participants (actual)
Lead sponsor: Milton S. Hershey Medical CenterUniversity, hospital or other
Collaborators: The Hollister Confidence Fund
Study start: 1 Sep 2021 (actual)
Primary completion: 25 May 2022 (actual)
Study completion: 25 May 2022 (actual)
First posted: 24 Aug 2021 (actual)
Results: Posted 18 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Aim 1: Assess Aevidum's curriculum in improving students' mental health knowledge and help-seeking intentions.

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

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

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).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Aevidum curriculum	Active comparator	Other: Aevidum curriculumCurriculum: 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.
Aevidum curriculum + club	Active comparator	Other: Aevidum curriculum, Other: ClubCurriculum + 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.

Who may qualify

Ages: 13 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aevidum curriculumThe 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.	Other	Aevidum curriculum, Aevidum curriculum + club
ClubSchools 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.	Other	Aevidum curriculum + club

Primary outcome

Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (1 of 4)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.

8 secondary outcomes

Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (1 of 8)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 (8 of 8)
Time frame: baseline (pre-intervention) and post-study completion (an average of 9 months)

Results and safety

Results posted to the registry on 18 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aevidum Curriculum	1,560	392
Aevidum Curriculum + Club	997	345

Primary outcome: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (1 of 4)

Time frame: baseline (pre-intervention) and post-study completion (an average of 9 months). Mean (95% Confidence Interval). Unit: score on a scale

Measure	Aevidum Curriculum n = 1560	Aevidum Curriculum + Club n = 997
How confident to identify someone showing depression?	0.33 (0.21 to 0.45)	0.29 (0.16 to 0.42)
How confident to help a friend?	0.26 (0.11 to 0.42)	0.24 (0.07 to 0.41)

Aevidum Curriculum vs Aevidum Curriculum + Club: Mean Difference (Net): 0.04 (95% CI -0.13 to 0.22), p = 0.642, Regression, Linear
Aevidum Curriculum vs Aevidum Curriculum + Club: Mean Difference (Net): 0.02 (95% CI -0.21 to 0.25), p = 0.864, Regression, Linear

Primary outcome: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (2 of 4)

Time frame: baseline (pre-intervention) and post-study completion (an average of 9 months). Number (95% Confidence Interval). Unit: odds ratio

Measure	Aevidum Curriculum n = 1560	Aevidum Curriculum + Club n = 997
Value	1.32 (0.94 to 1.84)	1.70 (1.15 to 2.50)

Aevidum Curriculum vs Aevidum Curriculum + Club: comparison of odds ratios: 0.78 (95% CI 0.47 to 1.30), p = 0.336, Regression, Logistic

Primary outcome: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (3 of 4)

Time frame: baseline (pre-intervention) and post-study completion (an average of 9 months). Number (95% Confidence Interval). Unit: odds ratio

Measure	Aevidum Curriculum n = 1560	Aevidum Curriculum + Club n = 997
Depression runs in families. Answer: true	1.41 (1.06 to 1.86)	1.34 (0.99 to 1.80)
Depression can be controlled through willpower. Answer: false	1.31 (1.07 to 1.60)	1.37 (1.09 to 1.71)
Depression is treatable. Answer: true	1.12 (0.86 to 1.46)	1.21 (0.89 to 1.64)
Abuse of alcohol and drugs can be a sign of depression. Answer: true	1.71 (0.98 to 2.97)	1.54 (0.91 to 2.59)
Depression is a sign of personal weakness. Answer: false	1.49 (1.19 to 1.85)	1.37 (1.03 to 1.82)

Aevidum Curriculum vs Aevidum Curriculum + Club: comparison of odds ratios: 1.05 (95% CI 0.70 to 1.59), p = 0.806, Regression, Logistic
Aevidum Curriculum vs Aevidum Curriculum + Club: comparison of odds ratios: 0.96 (95% CI 0.71 to 1.30), p = 0.781, Regression, Logistic
Aevidum Curriculum vs Aevidum Curriculum + Club: comparison of odds ratios: 0.93 (95% CI 0.62 to 1.39), p = 0.720, Regression, Logistic

Primary outcome: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (4 of 4)

Time frame: baseline (pre-intervention) and post-study completion (an average of 9 months). Number (95% Confidence Interval). Unit: odds ratio

Measure	Aevidum Curriculum n = 1560	Aevidum Curriculum + Club n = 997
Difficulty concentrating or making decisions	1.41 (1.05 to 1.88)	1.75 (1.24 to 2.47)
Feeling angry	1.39 (1.09 to 1.77)	1.71 (1.30 to 2.25)
Changes in sleep patterns	1.38 (0.92 to 2.05)	1.96 (1.23 to 3.11)
Frequent unexplained aches and pains	1.91 (1.57 to 2.34)	1.71 (1.39 to 2.10)
Feeling tired or less energetic	1.88 (1.12 to 3.15)	0.82 (0.50 to 1.36)
Eating more than usual	1.92 (1.52 to 2.43)	1.90 (1.45 to 2.47)
Feeling irritable or restless	1.34 (0.99 to 1.81)	1.61 (1.12 to 2.32)

Aevidum Curriculum vs Aevidum Curriculum + Club: comparison of odds ratios: 0.80 (95% CI 0.51 to 1.26), p = 0.340, Regression, Logistic
Aevidum Curriculum vs Aevidum Curriculum + Club: comparison of odds ratios: 0.81 (95% CI 0.56 to 1.17), p = 0.265, Regression, Logistic
Aevidum Curriculum vs Aevidum Curriculum + Club: comparison of odds ratios: 0.70 (95% CI 0.38 to 1.30), p = 0.259, Regression, Logistic

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aevidum Curriculum	0 of 0	0 of 0	0
Aevidum Curriculum + Club	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Aevidum curriculum and Club in people with Mental Health Wellness 1, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (1 of 4) (time frame: baseline (pre-intervention) and post-study completion (an average of 9 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05018689.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.