- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06549764
The YAM-project (Youth Aware of Mental Health) (YAM)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hellerup, Denmark, 2900
- Child and Adolescent Mental Health Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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,
|
Help-seeking and literacy increasing intervention
|
|
No Intervention: School as usual (9th grade curriculum) + help seeking information posters
School as usual - 9th grade curriculum + posters
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Three and six month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline, 3 + 6 month follow-up
|
|
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)
|
Baseline, 3 + 6 month follow-up
|
|
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)
|
Baseline, 3 + 6 month follow-up
|
|
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)
|
Baseline, 3 + 6 month follow-up
|
|
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)
|
Baseline, 3 + 6 month follow-up
|
|
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)
|
Baseline, 3 + 6 month follow-up
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-24000117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prevention, Suicide
-
University of Sao PauloNot yet recruitingSuicide Ideation | Suicide Attempts
-
University of North Carolina, Chapel HillVillage Heartbeat, Inc.RecruitingSuicide | Suicide Attempt | Suicide Ideation | Suicide PreventionUnited States
-
VA Office of Research and DevelopmentNot yet recruiting
-
VA Office of Research and DevelopmentNot yet recruiting
-
George Washington UniversityUniversity of Rochester; Mt. Sinai School of Medicine, New York, New York; American...Recruiting
-
Fundació Institut de Recerca de l'Hospital de la...Not yet recruitingSuicide | Suicide Risk | Suicide Attempt | Suicide Ideation | Suicide PreventionSpain
-
Yale UniversityNational Institute of Mental Health (NIMH); PossibleRecruiting
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH); Robert Wood Johnson FoundationRecruitingSuicide | Suicide Attempt | Suicide Ideation | Suicide PreventionUnited States
-
Syeda AYAT E ZAINAB AliUniversity of Leicester; University of WuerzburgRecruitingSuicide, Attempted | Suicide | Suicide Prevention | Completed SuicidePakistan
-
University of MichiganNational Institute of Mental Health (NIMH); Children's Hospital of Michigan; ...RecruitingBehavioral Symptoms | Suicide | Self-Injurious Behavior | Behavior | Suicide PreventionUnited States
Clinical Trials on Youth Aware of Mental Health
-
Fundacin Biomedica Galicia SurEnrolling by invitationSuicidal Ideation | Suicide, Attempted | Depressive Symptoms | Cyberbullying | Bullying | Help-Seeking Behavior | Suicide AwarenessSpain
-
Sanctuary Mental Health MinistriesExcellence in Giving InsightsNot yet recruitingMental Health | Mental Health Help-Seeking | Mental Health LiteracyUnited States
-
University of Maryland, College ParkEnrolling by invitationExperimental | Waitlist ControlUnited States
-
Charles Drew University of Medicine and ScienceLos Angeles County Department of Public HealthWithdrawnHealth Equity | Youth Participatory Action Research | Youth Mental Health
-
University of Southern DenmarkTrygFonden, Denmark; Region of Southern Denmark; Danske Regioner; Jascha FondenActive, not recruitingRandomized Controlled Trial | Mental Health Issue | Adolescents | Young Adults | Internet-Based Intervention | Well-Being | Body Dissatisfaction | Online InterventionDenmark
-
University of Southern DenmarkRegion of Southern Denmark; VU University of AmsterdamCompletedRecruitment | Feasibility Studies | Randomized Controlled Trial | Mental Health Issue | Young Adult | Internet-Based InterventionDenmark
-
University of Colorado, DenverNational Institute of Mental Health (NIMH)RecruitingSuicide PreventionUnited States
-
Innovation Research & TrainingCompletedSexual BehaviorUnited States
-
Innovation Research & TrainingCompleted
-
Innovation Research & TrainingEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedSexual Behavior | Violence, Domestic | Sexual AssaultUnited States