Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549764
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
The YAM-project Youth Aware of Mental Health
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
YAM
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 Kesslers 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
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 Kesslers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None