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Not yet recruiting NCT06359262

Evaluating the Hope@School Prevention Program

No phase Interventional Mental Health Wellness 1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hope@School, Treatment as usual.
Who it may be relevant to
Registry conditions: Mental Health Wellness 1. Basic parameters: 8 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Hope@School
    A digital platform aimed at promoting student mental health in schools
  • Other Treatment as usual
    Regular student health care in schools

Primary outcome measures

  • KIDSCREEN-27 Child version [Time frame: Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)]
Secondary outcome measures (5)
  • KIDSCREEN-27 Parent version [Time frame: Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)]
  • Mental Health-Promoting Knowledge (MHPK-10) [Time frame: 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 [Time frame: Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)]
  • Digital Addiction Scale for Children (DASC) [Time frame: 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 [Time frame: Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06359262 · KI-HAS-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗