The YAM-project (Youth Aware of Mental Health)

NCT ID: NCT06549764

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

297 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-08

Study Completion Date

2025-07-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prevention, Suicide

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-armed, cluster, randomized feasibility trial (unstratified, blinded analyses, 1:1 allocation
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental intervention + school as usual (9th grade curriculum)

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,

Group Type EXPERIMENTAL

Youth Aware of Mental Health

Intervention Type BEHAVIORAL

Help-seeking and literacy increasing intervention

School as usual (9th grade curriculum) + help seeking information posters

School as usual - 9th grade curriculum + posters

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Youth Aware of Mental Health

Help-seeking and literacy increasing intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Inclusion criteria: The inclusion criteria for schools are public schools, which as a minimum have 2 parallel classes of 9th grade with students aged 15+ years.

Exclusion criteria: Schools specialized towards specific groups of students, such as vulnerable groups, and schools, which are providing treatment for students with special needs (in DK: behandlingsskoler og specialskoler) are omitted from participation in the trial. The reason is that these groups of students are considered particularly vulnerable, often with specific diagnoses and special needs for individual support, which do not correspond with the manualized YAM intervention. Boarding schools (in DK: efterskoler) with 9th grade students will be offered to serve as test schools during the training of YAM-instructors but are not eligible per se. Being boarding schools, social interactions between peers might differ in intensity and character from those of schools where children are living at home only attending during school hours.
Minimum Eligible Age

15 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Karolinska Institutet

OTHER

Sponsor Role collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Britt Reuter Morthorst

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Child and Adolescent Mental Health Services

Hellerup, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-24000117

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.