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Completed

NCT Number: NCT05018689

Evaluation of the Aevidum Curriculum and Club

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.

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Key information

Conditions

Mental Health Wellness 1 Behavior Personal Satisfaction Psychological Well-Being

Age range

13 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aevidum curriculum

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

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. 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)

    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.

  2. 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)

    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.

  3. 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)

    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.

  4. 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)

    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.

  5. 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)

    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.

  6. 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)

    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.

  7. 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)

    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.

  8. 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)

    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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • The Hollister Confidence Fund

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 24, 2021
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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