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NCT Number: NCT06359262

Evaluating the Hope@School Prevention Program

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.

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Key information

Conditions

Mental Health Wellness 1

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hope@School

Other

A digital platform aimed at promoting student mental health in schools

Treatment as Usual

Other

Regular student health care in schools

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jens Högström, Ass. prof

CONTACT

[email protected]

0046 70 9689161

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study 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

Acronym: Hope@School

Important dates

Study start
2027
Primary completion
2027
Study completion
2028
First posted
Apr 11, 2024
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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