Evaluating the Hope@School Prevention Program

Not Applicable

Not yet recruiting

• Conditions: Mental Health Wellness 1
• Interventions: Other: Hope@School; Other: Treatment as usual

• Registration Number: NCT06359262
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-05
• Last Update Submitted: 2024-04-05
• Study First Posted: 2024-04-11
• Last Update Posted: 2024-04-11
• Study Start: 2027-01-01
• Primary Completion: 2027-12-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hope@School	Hope@School	The universal prevention program Hope@School. A digital platform with a number of tools that target mental health and wellbeing in children and adolescents.
Treatment as usual	Treatment as usual	Regular student health care in the schools

Primary Outcome Measures

Name	Time	Method
KIDSCREEN-27 Child version	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 Outcome Measures

Name	Time	Method
Mental Health-Promoting Knowledge (MHPK-10)	Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)	Level of child-rated mental health literacy as measured by a questionnaire
KIDSCREEN-27 Parent version	Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)	Level of parent-rated quality of life (the child's quality of life) as measured by a questionnaire
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)	Level of child-rated healthy behaviours as measured by a questionnaire
Digital Addiction Scale for Children (DASC)	Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)	Level of child-rated addictive digital behaviours as measured by a questionnaire
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)	Level of child-rated harmful digital practices as measured by a questionnaire