Mental Health Wellness 1Hope@SchoolNCT06359262
Evaluating the Hope@School Prevention Program
A study testing Hope@School and Treatment as usual in people with Mental Health Wellness 1, run by Karolinska Institutet.
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… Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Hope@School and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,220 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age between 8 and 18 years
- Attends school included in the study
- Consents to participate
Who cannot join
- Younger than 8 and older than 18 years
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Hope@School, Treatment as usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hope@SchoolOther
A digital platform aimed at promoting student mental health in schools
Treatment as usualOther
Regular student health care in schools
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Hope@School |
| Treatment as usual | Active comparator | Regular student health care in the schools Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
KIDSCREEN-27 Child version
Level of child-rated quality of life as measured by a questionnaire
Measured: Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)
Secondary outcomes (5)
KIDSCREEN-27 Parent version
Level of parent-rated quality of life (the child's quality of life) as measured by a questionnaire
Measured: Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)
Mental Health-Promoting Knowledge (MHPK-10)
Level of child-rated mental health literacy as measured by a questionnaire
Measured: 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
Level of child-rated healthy behaviours as measured by a questionnaire
Measured: Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)
Digital Addiction Scale for Children (DASC)
Level of child-rated addictive digital behaviours as measured by a questionnaire
Measured: 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
Level of child-rated harmful digital practices as measured by a questionnaire
Measured: Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Jan 2027 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Högström, Karolinska Institutet
- Investigators
- Jens Högström, Ass prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359262
- Sponsor's protocol ID
- KI-HAS-001
- Acronym
- Hope@School
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06359262
- Acronym / sponsor ID
- Hope@School / KI-HAS-001
- Conditions
- Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,220 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hope@School | Experimental | Other: Hope@SchoolThe 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 | Active comparator | Other: Treatment as usualRegular student health care in the schools |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age between 8 and 18 years
- Attends school included in the study
- Consents to participate
Key exclusion criteria (1 listed)
- Younger than 8 and older than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hope@SchoolA digital platform aimed at promoting student mental health in schools | Other | Hope@School |
| Treatment as usualRegular student health care in schools | Other | Treatment as usual |
Primary outcome
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
5 secondary outcomes
KIDSCREEN-27 Parent version
Time frame: 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)
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)
Digital Addiction Scale for Children (DASC)
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jens Högström, Ass prof principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A study testing Hope@School and Treatment as usual in people with Mental Health Wellness 1, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jens Högström, Ass. prof (0046 70 9689161, jens.hogstrom@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KIDSCREEN-27 Child version (time frame: Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.