NCT06549764

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
297

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

August 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2025

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

July 11, 2024

Last Update Submit

September 23, 2025

Conditions

Outcome Measures

Primary Outcomes (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

    Three and six month follow-up

Secondary Outcomes (6)

  • Paykel's Suicidal Feelings in the General Population Questionnaire

    Baseline, 3 + 6 month follow-up

  • WHO Well-being Scale (WHO-5)

    Baseline, 3 + 6 month follow-up

  • Depression, anxiety, and stress scale (DASS21)

    Baseline, 3 + 6 month follow-up

  • General help-seeking questionnaire

    Baseline, 3 + 6 month follow-up

  • Kessler's Psychological Distress Scale (K-10)

    Baseline, 3 + 6 month follow-up

  • +1 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL

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,

Behavioral: Youth Aware of Mental Health

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

NO INTERVENTION

School as usual - 9th grade curriculum + posters

Interventions

Help-seeking and literacy increasing intervention

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

Eligibility Criteria

Age15 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child and Adolescent Mental Health Services

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Suicide Prevention

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two-armed, cluster, randomized feasibility trial (unstratified, blinded analyses, 1:1 allocation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 11, 2024

First Posted

August 12, 2024

Study Start

August 8, 2024

Primary Completion

February 18, 2025

Study Completion

July 25, 2025

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations