Evaluating the Hope@School Prevention Program

NCT06359262 | Not Yet Recruiting

• 1 other identifier: KI-HAS-001
• Study Type: interventional
• Target: 3,220
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mental Health Wellness 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• KIDSCREEN-27 Parent version

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

• Mental Health-Promoting Knowledge (MHPK-10)

  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)

Study Arms (2)

Hope@School

EXPERIMENTAL

The universal prevention program Hope@School. A digital platform with a number of tools that target mental health and wellbeing in children and adolescents.

Other: Hope@School

Treatment as usual

ACTIVE COMPARATOR

Regular student health care in the schools

Other: Treatment as usual

Interventions

Hope@School OTHER

A digital platform aimed at promoting student mental health in schools

Hope@School

Treatment as usual OTHER

Regular student health care in schools

Treatment as usual

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- Younger than 8 and older than 18 years

Sponsors & Collaborators

• Karolinska Institutet: lead

MeSH Terms

Interventions

Therapeutics

Study Officials

• Jens Högström, Ass prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Högström, Ass. prof

CONTACT

0046 70 9689161; jens.hogstrom@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 11, 2024
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: April 11, 2024

Record last verified: 2024-04