N/A N=2,557 Randomized Prevention

Evaluation of the Aevidum Curriculum and Club

Mental Health Wellness 1

Bottom Line

View on ClinicalTrials.gov: NCT05018689 ↗

Enrolled (actual)

2,557

Serious AEs

—

Results posted

Oct 2024

Primary outcome: Primary: Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (1 of 4) — 0.33; 0.29; 0.26; 0.24 score on a scale — p=0.642

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Aevidum curriculum (Other); Club (Other)
Age: Pediatric, Adult · 13+ yrs
Sex: All
Sponsor: Milton S. Hershey Medical Center
Primary completion: May 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (1 of 4)	0.33; 0.29; 0.26; 0.24	0.642
PRIMARY Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (2 of 4)	1.32; 1.70	0.336
PRIMARY Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (3 of 4)	1.41; 1.34; 1.31; 1.37; 1.12; 1.21	0.806
PRIMARY Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Knowledge Scores From Baseline (4 of 4)	1.41; 1.75; 1.39; 1.71; 1.38; 1.96	0.340
PRIMARY Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Help-seeking Intentions Scores From Baseline (1 of 3)	0.05; 0.03; 0.0; 0.05; 0.13; 0.06	0.800
PRIMARY Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Help-seeking Intentions Scores From Baseline (2 of 3)	1.10; 0.86; 1.28; 1.14	0.086
PRIMARY Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Help-seeking Intentions Scores From Baseline (3 of 3)	0.11; 0.05	0.199
SECONDARY Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (1 of 8)	-0.10; 0.15; -0.11; 0.07; -0.02; -0.08	<0.001 sig
SECONDARY Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (2 of 8)	-0.16; -0.21	0.718
SECONDARY Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (3 of 8)	0.36; 0.15	0.090
SECONDARY Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (4 of 8)	0.98; 1.00; 1.22; 1.03; 1.18; 1.10	0.944
SECONDARY Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (5 of 8)	0.0; 0.02; 0.04; -0.02	0.769
SECONDARY Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (6 of 8)	0.86; 1.0; 0.86; 0.88; 0.97; 0.89	0.345
SECONDARY Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (7 of 8)	-0.08; 0.01	0.141
SECONDARY Change in University of Michigan Depression Center Peer-to-Peer Depression Awareness Assessment Perceptions of School Culture Scores From Baseline (8 of 8)	0.0; -0.04	0.392

Summary

The study purpose is to evaluate the effectiveness of the Aevidum curriculum (plus/minus club) to improve adolescent mental health knowledge, help-seeking intentions, and school culture. Investigators will partner with 12 high schools for this study. Prior to the start of the 2021-2022 academic year, schools will be recruited and randomly assigned to implement the Aevidum curriculum (n=6) or the curriculum and club (n=6). Please note, ultimately a total of 10 schools were recruited, with 5 assigned to each arm.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Students not enrolled in one of the participating high schools (n=12)
Students not in grades 9-12
Students with disabilities that are deemed unable to participate by the school district
Non-English speaking students as curriculum and club materials are taught/available in English only at this time

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05018689). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.