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Completed

NCT Number: NCT06549764

The YAM-project (Youth Aware of Mental Health)

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

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Key information

Age range

15 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child and Adolescent Mental Health Services

Hellerup, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Youth Aware of Mental Health

Behavioral

Help-seeking and literacy increasing intervention

Primary outcomes

  1. 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

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

    Time frame: Baseline, 3 + 6 month follow-up

    Five item tool with yes/no reply options

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

    Time frame: Baseline, 3 + 6 month follow-up

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

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

    Time frame: Baseline, 3 + 6 month follow-up

    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)

  4. General help-seeking questionnaire

    Time frame: Baseline, 3 + 6 month follow-up

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

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

    Time frame: Baseline, 3 + 6 month follow-up

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

  6. YAM scales

    Time frame: Baseline, 3 + 6 month follow-up

    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)

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study 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

Acronym: YAM

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2024
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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