Evaluating the Hope@School Prevention Program (Hope@School)

April 5, 2024 updated by: Jens Högström, Karolinska Institutet

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Hope@School
A digital platform aimed at promoting student mental health in schools
Active Comparator: Treatment as usual
Regular student health care in the schools
Other: Treatment as usual
Regular student health care in schools

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KIDSCREEN-27 Parent version
Time Frame: 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
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)
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)
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)
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)
Digital Addiction Scale for Children (DASC)
Time Frame: 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
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Jens Högström, Ass prof, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

April 2, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • KI-HAS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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