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Prevention, SuicideYAMNCT06549764

The YAM-project (Youth Aware of Mental Health)

A study testing Youth Aware of Mental Health in people with Prevention, Suicide, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 15 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Prevention, Suicide
What is being tested?
Youth Aware of Mental Health
Could I receive a placebo?
No, everyone receives an active treatment
How many people
297 participants
Where
1 siteDenmark
Study dates
8 Aug 2024to 25 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Child and Adolescent Mental Health Services

    Hellerup, 2900

Other trials in Denmark

About this study

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

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

Read the 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.

Being tested
Youth Aware of Mental Health
Medical subject headings
Suicide Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Youth Aware of Mental HealthBehavioural

    Help-seeking and literacy increasing intervention

Study groups in NCT06549764
Study groupRoleWhat they receive
Experimental intervention + school as usual (9th grade curriculum)ExperimentalThe 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,
Receives: Behavioral: Youth Aware of Mental Health
School as usual (9th grade curriculum) + help seeking information postersNo interventionSchool as usual - 9th grade curriculum + posters

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility, acceptability and fidelity outcomes

    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

    Measured: Three and six month follow-up

Secondary outcomes (6)

  1. Paykel's Suicidal Feelings in the General Population Questionnaire

    Five item tool with yes/no reply options

    Measured: Baseline, 3 + 6 month follow-up

  2. WHO Well-being Scale (WHO-5)

    Validated measure of adolescents' quality of life. Five-item, five point likert scale (Range: all the time to at no point in time)

    Measured: Baseline, 3 + 6 month follow-up

  3. Depression, anxiety, and stress scale (DASS21)

    21-item sacle incl. subscales; five point likert scale (range: did not apply to me to did apply to me all or most of the time)

    Measured: Baseline, 3 + 6 month follow-up

  4. General help-seeking questionnaire

    Help-seeking intentions \& behaviours; two nine-item, five point likerts scales(range very likely to very unlikely)

    Measured: Baseline, 3 + 6 month follow-up

  5. Kessler's Psychological Distress Scale (K-10)

    A 10- + 5-item likert measure (range: all the time to not a any time point)

    Measured: Baseline, 3 + 6 month follow-up

  6. YAM scales

    Measures of stigma and literacy; 26-item scale, reply: True/False/don't know + 16-item, five-point likert scale (range: very much agree to very much disagree)

    Measured: Baseline, 3 + 6 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2024
  2. Study start8 Aug 2024
  3. Primary completion18 Feb 2025
  4. Study completion25 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-armed, cluster, randomized feasibility trial (unstratified, blinded analyses, 1:1 allocation
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06549764
Sponsor's protocol ID
H-24000117
Acronym
YAM
Status last verified
Sep 2025
First submitted
11 Jul 2024
Last updated
29 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Harris LK, Heinrichsen M, Petri M, Elberling H, Forman JL, Nordentoft M, Erlangsen A, Morthorst BR. Youth Aware of Mental Health for Danish School Adolescents: Study Protocol for a Cluster-Randomized Feasibility Pilot Trial. Int J Methods Psychiatr Res. 2026 Mar;35(1):e70064. doi: 10.1002/mpr.70064.

    PubMed 41800799

Questions about this trial

What is this clinical trial studying?

A study testing Youth Aware of Mental Health in people with Prevention, Suicide, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility, acceptability and fidelity outcomes (time frame: Three and six month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06549764, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.

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