Evaluating the Hope@School Prevention Program

Mental Health Wellness 1 Clinical Trial

— Hope@School  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06359262
• Other study ID #: KI-HAS-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2027
• Est. completion date: December 30, 2028

Study information

• Verified date: April 2024
• Source: Karolinska Institutet
• Contact: Jens Högström, Ass. prof
• Phone: 0046 70 9689161
• Email: jens.hogstrom[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3220
• Est. completion date: December 30, 2028
• Est. primary completion date: December 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KIDSCREEN-27 Child version	Level of child-rated quality of life as measured by a questionnaire	Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)
Secondary	KIDSCREEN-27 Parent version	Level of parent-rated quality of life (the child's quality of life) as measured by a questionnaire	Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)
Secondary	Mental Health-Promoting Knowledge (MHPK-10)	Level of child-rated mental health literacy as measured by a questionnaire	Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)
Secondary	Healthy Behaviours in School-aged Children survey protocol (HBSC) part 1	Level of child-rated healthy behaviours as measured by a questionnaire	Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)
Secondary	Digital Addiction Scale for Children (DASC)	Level of child-rated addictive digital behaviours as measured by a questionnaire	Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)
Secondary	Healthy Behaviours in School-aged Children survey protocol (HBSC) part 2	Level of child-rated harmful digital practices as measured by a questionnaire	Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)