Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Hollister Confidence Fund | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State College of Medicine | Hershey | Pennsylvania | 17033 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline (pre-intervention) and post-study completion (an average of 9 months) |
|
Not provided
As this was an educational curriculum and club evaluation, all-cause mortality, serious, and other (not including serious) adverse events were not monitored/assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deepa Sekhar | Penn State College of Medicine | 717-531-0003 | x281334 | dsekhar@pennstatehealth.psu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 6, 2022 | Jan 5, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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. | 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. | 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. | 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. | baseline assessment (pre-intervention) at the start of the school year and post-assessment after curriculum +/- club delivery (an average of 9 months) |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | baseline (pre-intervention) and post-study completion (an average of 9 months) |
| BG001 | 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. 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Grade | Count of Participants | Participants |
|
| OG001 | 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. 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. 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. |
|
|
|
| Primary | 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. | Posted | Number | 95% Confidence Interval | odds ratio | baseline (pre-intervention) and post-study completion (an average of 9 months) |
|
|
|
|
| Primary | 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. | Posted | Number | 95% Confidence Interval | odds ratio | baseline (pre-intervention) and post-study completion (an average of 9 months) |
|
|
|
|
| Primary | 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. | Posted | Number | 95% Confidence Interval | odds ratio | baseline (pre-intervention) and post-study completion (an average of 9 months) |
|
|
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline (pre-intervention) and post-study completion (an average of 9 months) |
|
|
|
|
| Primary | 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. | Posted | Number | 95% Confidence Interval | odds ratio | baseline (pre-intervention) and post-study completion (an average of 9 months) |
|
|
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline assessment (pre-intervention) at the start of the school year and post-assessment after curriculum +/- club delivery (an average of 9 months) |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline (pre-intervention) and post-study completion (an average of 9 months) |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline (pre-intervention) and post-study completion (an average of 9 months) |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline (pre-intervention) and post-study completion (an average of 9 months) |
|
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | odds ratio | baseline (pre-intervention) and post-study completion (an average of 9 months) |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline (pre-intervention) and post-study completion (an average of 9 months) |
|
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | odds ratio | baseline (pre-intervention) and post-study completion (an average of 9 months) |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline (pre-intervention) and post-study completion (an average of 9 months) |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline (pre-intervention) and post-study completion (an average of 9 months) |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. 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. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| Depression is treatable. Answer: true |
|
| Abuse of alcohol and drugs can be a sign of depression. Answer: true |
|
| Depression is a sign of personal weakness. Answer: false |
|
| Regression, Logistic |
| 0.781 |
| comparison of odds ratios |
| 0.96 |
| 2-Sided |
| 95 |
| 0.71 |
| 1.30 |
| Superiority |
| Depression is treatable. Answer: true | Regression, Logistic | 0.720 | comparison of odds ratios | 0.93 | 2-Sided | 95 | 0.62 | 1.39 | Superiority |
| Abuse of alcohol and drugs can be a sign of depression. Answer: true | Regression, Logistic | 0.784 | comparison of odds ratios | 1.11 | 2-Sided | 95 | 0.52 | 2.38 | Superiority |
| Depression is a sign of personal weakness. Answer: false | Regression, Logistic | 0.662 | comparison of odds ratios | 1.08 | 2-Sided | 95 | 0.76 | 1.55 | Superiority |
| Changes in sleep patterns |
|
| Frequent unexplained aches and pains |
|
| Feeling tired or less energetic |
|
| Eating more than usual |
|
| Feeling irritable or restless |
|
| 0.265 |
| comparison of odds ratios |
| 0.81 |
| 2-Sided |
| 95 |
| 0.56 |
| 1.17 |
| Superiority |
| Changes in sleep patterns | Regression, Logistic | 0.259 | comparison of odds ratios | 0.70 | 2-Sided | 95 | 0.38 | 1.30 | Superiority |
| Frequent unexplained aches and pains | Regression, Logistic | 0.450 | comparison of odds ratios | 1.12 | 2-Sided | 95 | 0.84 | 1.49 | Superiority |
| Feeling tired or less energetic | Regression, Logistic | 0.025 | comparison of odds ratios | 2.28 | 2-Sided | 95 | 1.11 | 4.69 | Superiority |
| Eating more than usual | Regression, Logistic | 0.937 | comparison of odds ratios | 1.01 | 2-Sided | 95 | 0.71 | 1.44 | Superiority |
| Feeling irritable or restless | Regression, Logistic | 0.447 | comparison of odds ratios | 0.83 | 2-Sided | 95 | 0.52 | 1.34 | Superiority |
| School counselor |
|
| Teacher |
|
| Mental health professional (psychologist, psychiatrist, social worker) |
|
| Doctor |
|
| Internet/website |
|
| Clergy, priest, rabbi, or other religious person |
|
| Phone helpline |
|
| Crisis textline |
|
| Other relative (i.e., sister, brother, aunt, uncle) |
|
| Boyfriend or girlfriend |
|
| Coach |
|
| 0.451 |
| Mean Difference (Net) |
| -0.05 |
| 2-Sided |
| 95 |
| -0.18 |
| 0.08 |
| Superiority |
| School counselor | Regression, Linear | 0.335 | Mean Difference (Net) | 0.07 | 2-Sided | 95 | -0.07 | 0.2 | Superiority |
| Teacher | Regression, Linear | 0.554 | Mean Difference (Net) | -0.04 | 2-Sided | 95 | -0.17 | 0.09 | Superiority |
| Mental health professional | Regression, Linear | 0.541 | Mean Difference (Net) | -0.04 | 2-Sided | 95 | -0.19 | 0.10 | Superiority |
| Doctor | Regression, Linear | 0.454 | Mean Difference (Net) | 0.05 | 2-Sided | 95 | -0.09 | 0.19 | Superiority |
| Internet/website | Regression, Linear | 0.749 | Mean Difference (Net) | -0.02 | 2-Sided | 95 | -0.16 | 0.12 | Superiority |
| Clergy, priest, rabbi, or other religious person | Regression, Linear | 0.030 | Mean Difference (Net) | -0.13 | 2-Sided | 95 | -0.24 | -0.01 | Superiority |
| Phone helpline | Regression, Linear | 0.334 | Mean Difference (Net) | 0.06 | 2-Sided | 95 | -0.06 | 0.18 | Superiority |
| Crisis textline | Regression, Linear | 0.243 | Mean Difference (Net) | 0.07 | 2-Sided | 95 | -0.05 | 0.20 | Superiority |
| Other relative (i.e., sister, brother, aunt, uncle) | Regression, Linear | 0.492 | Mean Difference (Net) | -0.05 | 2-Sided | 95 | -0.19 | 0.09 | Superiority |
| Boyfriend or girlfriend | Regression, Linear | 0.610 | Mean Difference (Net) | -0.04 | 2-Sided | 95 | -0.17 | 0.10 | Superiority |
| Coach | Regression, Linear | 0.061 | Mean Difference (Net) | -0.12 | 2-Sided | 95 | -0.25 | 0.01 | Superiority |
| Regression, Logistic |
| 0.526 |
| comparison of odds ratios |
| 1.13 |
| 2-Sided |
| 95 |
| 0.77 |
| 1.66 |
| Superiority |
| I would have sympathy for the new student |
|
| The new student makes me feel scared |
|
| The new student makes me feel uncomfortable |
|
| I would help the new student even if I did not know him or her well |
|
| I would try to stay away from the new student |
|
| The new student would be made fun of at my school |
|
| The new student would be ignored at my school |
|
| I think other students in my school would try to help the new student |
|
| Regression, Linear |
| 0.003 |
| Mean Difference (Net) |
| -0.18 |
| 2-Sided |
| 95 |
| -0.29 |
| -0.06 |
| Superiority |
| I would have sympathy for the new student | Regression, Linear | 0.310 | Mean Difference (Net) | 0.06 | 2-Sided | 95 | -0.06 | 0.18 | Superiority |
| The new student makes me feel scared | Regression, Linear | 0.114 | Mean Difference (Net) | -0.10 | 2-Sided | 95 | -0.21 | 0.02 | Superiority |
| The new student makes me feel uncomfortable | Regression, Linear | 0.738 | Mean Difference (Net) | 0.02 | 2-Sided | 95 | -0.10 | 0.15 | Superiority |
| I would help the new student even if I did not know him or her well | Regression, Linear | 0.040 | Mean Difference (Net) | 0.12 | 2-Sided | 95 | 0.01 | 0.24 | Superiority |
| I would try to stay away from the new student | Regression, Linear | 0.006 | Mean Difference (Net) | -0.17 | 2-Sided | 95 | -0.29 | -0.05 | Superiority |
| The new student would be made fun of at my school | Regression, Linear | 0.798 | Mean Difference (Net) | -0.02 | 2-Sided | 95 | -0.15 | 0.11 | Superiority |
| The new student would be ignored at my school | Regression, Linear | 0.197 | Mean Difference (Net) | -0.09 | 2-Sided | 95 | -0.22 | 0.05 | Superiority |
| I think other students in my school would try to help the new student | Regression, Linear | 0.623 | Mean Difference (Net) | 0.03 | 2-Sided | 95 | -0.10 | 0.16 | Superiority |
| Thoughts of suicide |
|
| I do not think there are any mental health issues that are concerning for students |
|
| Other |
|
| 0.369 |
| comparison of odds ratios |
| 1.18 |
| 2-Sided |
| 95 |
| 0.82 |
| 1.68 |
| Superiority |
| Thoughts of suicide | Regression, Logistic | 0.676 | comparison of odds ratios | 1.07 | 2-Sided | 95 | 0.77 | 1.50 | Superiority |
| I do not think there are any mental health issues that are concerning for students | Regression, Logistic | 0.432 | comparison of odds ratios | 0.79 | 2-Sided | 95 | 0.44 | 1.42 | Superiority |
| Other | Regression, Logistic | 0.533 | comparison of odds ratios | 0.87 | 2-Sided | 95 | 0.56 | 1.35 | Superiority |
| Regression, Linear |
| 0.315 |
| Mean Difference (Net) |
| 0.05 |
| 2-Sided |
| 95 |
| -0.05 |
| 0.16 |
| Superiority |
| Mental health information on school website |
|
| Other |
|
| 0.899 |
| comparison of odds ratios |
| 0.98 |
| 2-Sided |
| 95 |
| 0.73 |
| 1.33 |
| Superiority |
| Mental health information on school website | Regression, Logistic | 0.612 | comparison of odds ratios | 1.08 | 2-Sided | 95 | 0.80 | 1.48 | Superiority |
| Other | Regression, Logistic | 0.476 | comparison of odds ratios | 1.14 | 2-Sided | 95 | 0.79 | 1.65 | Superiority |