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Clinical Trials/NCT06359262
NCT06359262
Not Yet Recruiting
N/A

Feasibility, Effectiveness and Overall Impact of the Hope@School Universal Prevention Program Promoting Child and Adolescent Mental Health in Schools: A Two-arm Randomized Controlled Trial Across Seven European Countries

Karolinska Institutet0 sites3,220 target enrollmentJanuary 1, 2027

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mental Health Wellness 1
Sponsor
Karolinska Institutet
Enrollment
3220
Primary Endpoint
KIDSCREEN-27 Child version
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This multi-center cluster-randomized controlled trial aims to evaluate the feasibility, effectiveness and overall impact of the Hope@School (H@S) program by comparing mental health outcomes in students participating in the H@S program with students having only access to regular student health care (treatment as usual - TAU).

The primary objectives of the study are:

To determine if the H@S program is feasible, acceptable, usable and safe for students, families, teachers and school leaders To establish if the H@S program is associated with improvements in quality of life, everyday functioning, peer relations and general mental health.

Registry
clinicaltrials.gov
Start Date
January 1, 2027
End Date
December 30, 2028
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jens Högström

Associate professor

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

  • Age between 8 and 18 years
  • Attends school included in the study
  • Consents to participate

Exclusion Criteria

  • Younger than 8 and older than 18 years

Outcomes

Primary Outcomes

KIDSCREEN-27 Child version

Time Frame: Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)

Level of child-rated quality of life as measured by a questionnaire

Secondary Outcomes

  • Mental Health-Promoting Knowledge (MHPK-10)(Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint))
  • KIDSCREEN-27 Parent version(Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint))
  • Healthy Behaviours in School-aged Children survey protocol (HBSC) part 1(Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint))
  • Digital Addiction Scale for Children (DASC)(Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint))
  • Healthy Behaviours in School-aged Children survey protocol (HBSC) part 2(Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint))

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