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Clinical Trials/NCT06549764
NCT06549764
Completed
N/A

Youth Aware of Mental Health (the YAM-project) - a School-based Program for Mental Health Promotion and Well-being in 9th Grade Students: a Cluster-randomized, Feasibility Trial

Mental Health Services in the Capital Region, Denmark1 site in 1 country297 target enrollmentAugust 8, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prevention, Suicide
Sponsor
Mental Health Services in the Capital Region, Denmark
Enrollment
297
Locations
1
Primary Endpoint
Feasibility, acceptability and fidelity outcomes
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

Two-armed, cluster, randimized feasibility trial investigating the feasibility of the Youth Aware of Mental Health (YAM) intervention provided 9th grade students.

Detailed Description

Estimated 4% of adolescents aged 12-15 years' experience suicidal ideation increasing to 16% in 16-year-olds in school samples. Universal, up-stream prevention strategies such as school programs have been suggested and investigated, however, country specific feasibility insights are needed. The aim is to evaluate the feasibility, acceptability, and fidelity of a school-based Youth Aware of Mental Health (YAM) programme in Danish 9th grade student as measured by 1) program participation and response rates, 2) student endorsement, and 3) manual adherence. Also, to explore whether the YAM-programme is associated with increased mental health awareness and lower rates of suicidal ideation and behaviour. An RCT designed as a 2-arm observer-blinded, cluster-randomised feasibility trial, where students either receive the manualized YAM- program as add on to the general school curriculum or school curriculum as usual + posters. The feasibility trial will be conducted in 8-10 Danish public schools across the country. The goal of the YAM program is to raise student awareness about protective and risk factors for suicidal behaviour, enhance general knowledge on mental disorders, and improve coping strategies for dealing with adversities, such as negative life events and emotional distress. The manualized YAM-program has previously been linked to reductions in SI and DSH. The YAM-program consists of a booklet, posters, discussions, lectures, and role-playing games and will be delivered to students aged 15-16 years. During the 3-week of the intervention, 6 educational posters will remain on display in the classroom, also in the control schools. Secondary explorative outcomes include quality of life assessed by WHO Well-being Scale (WHO-5), which has been validated as a measure of adolescents' quality of life; psychological distress as measured by the Kessler's Psychological Distress Scale (K-10), a standard and validated tool; help-seeking intentions will be measured using the General help-seeking questionnaire, again a validated tool to measure mental health knowledge and literacy, respectively. Lastly, level of suicide stigma and literacy will be calculated from the validated Stigma of Suicide Scale. All questionnaires have been tested and found suitable for adolescents.

Registry
clinicaltrials.gov
Start Date
August 8, 2024
End Date
July 25, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mental Health Services in the Capital Region, Denmark
Responsible Party
Principal Investigator
Principal Investigator

Britt Reuter Morthorst

Associate professor

Mental Health Services in the Capital Region, Denmark

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Feasibility, acceptability and fidelity outcomes

Time Frame: Three and six month follow-up

Participation rates, i.e., percentage of parents and adolescent consenting to participate, Percentage of students attending the YAM classes (≥4 out of 5 sessions), Response rates of participating students to questionnaires at three and six months of follow-up, YAM questions regarding student endorsement, Checklist of milestones on the implementation plan

Secondary Outcomes

  • General help-seeking questionnaire(Baseline, 3 + 6 month follow-up)
  • Paykel's Suicidal Feelings in the General Population Questionnaire(Baseline, 3 + 6 month follow-up)
  • Kessler's Psychological Distress Scale (K-10)(Baseline, 3 + 6 month follow-up)
  • WHO Well-being Scale (WHO-5)(Baseline, 3 + 6 month follow-up)
  • Depression, anxiety, and stress scale (DASS21)(Baseline, 3 + 6 month follow-up)
  • YAM scales(Baseline, 3 + 6 month follow-up)

Study Sites (1)

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