Sleep QualityNCT07030556
Cascading A Healthy Sleep Intervention In Vocational Education
A study testing Healthy Sleep Intervention, Co-creation process and Training for teachers in people with Sleep Quality and Implementation, run by University Ghent at 1 site in Belgium.
Trial summary
Sleep is crucial for the mental, cognitive and physical health of adolescents. However, teenagers in 2024 sleep less and less and their sleep is of poorer quality. It is striking that adolescents who follow vocational education sleep even worse compared to peers who follow a technical or general education. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Implementation
- What is being tested?
- Healthy Sleep Intervention, Co-creation process and Training for teachers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Jun 2025to 30 Jun 2026
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- student in 1st or 2nd year of secondary vocational education
- teacher who helped implement the intervention
Who cannot join
- No students who participated in the co-creation process may participate in the group interview about receiving the intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University
Ghent, 9000
Ann Vandendriessche, PhD, 093328393, ann.vandendriessche@ugent.be
benedicte.deforche@ugent.be
About this study
Official title: Cascading an Intervention to Promote Healthy Sleep Among Adolescents Following Vocational Education Via a Participatory Approach
Sleep is crucial for the mental, cognitive and physical health of adolescents. However, teenagers in 2024 sleep less and less and their sleep is of poorer quality. It is striking that adolescents who follow vocational education sleep even worse compared to peers who follow a technical or general education. It is therefore important to focus on this risk group of adolescents to reduce health differences. However, there are no previous intervention studies that focused on them.
In previous research, a healthy sleep intervention was already developed, implemented and evaluated in a participatory manner. Within this research, the investigators want to focus on evaluating the process of implementation of this intervention among first and second year secondary school students (12 to 14 year olds) and teachers from vocational education. Based on the results of this process evaluation, the investigators want to deliver this intervention as a ready-made package to Flemish secondary schools.
- Conditions
- Sleep Quality, Implementation
- Being tested
- Healthy Sleep Intervention, Co-creation process, Training for teachers
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Sleep InterventionOther
This intervention has a duration of nine weeks and starts with a kick-off event where the students of the action group provide explanations to fellow students. Furthermore, the intervention is structured in five themes of approximately two weeks each: 1) importance of healthy sleep, 2) sleep and wake cycle, 3) screen time, 4) exercise and nutrition and 5) screen use and mental well-being. Three posters are provided for each theme, five to seven Instagram posts and a class discussion. In addition, healthy sleep is explained during the biology lesson. Furthermore, a competition between classes is organized to sleep as well as possible with the help of an app, classes are given a planner to visualize the workload of school tasks, exercise snacks will be introduced during the lessons and students are given a notebook to write things down in case of worrying. Finally, a closing moment is provided. Flyers with information about healthy sleep in young people are distributed to parents.
Co-creation processOther
co-creation process with students and teachers: to adapt the existing intervention to the needs of the school. For this, schools can recruit 6 to 8 students via purposeful sampling to form an action group. They will be asked to participate in two sessions during the lunch break in which 1) the needs of the students at school in relation to healthy sleep are mapped out and the goals of the already developed intervention are supplemented or not based on the needs 2) a choice is made from the already developed intervention components 3) necessary adjustments are made to intervention components.
Training for teachersOther
implementation of the implementation intervention for teachers. The implementation intervention consists of a one-off training for all teachers of the 1st and 2nd year of secondary school in which the importance of sleep and the intervention and its materials are explained. A manual per theme is then provided to the teachers who will implement components (see also appendix 'Manual Sleep Project'). Consultation moments will be planned in consultation to discuss the progress of the implementation.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Sleep Intervention | Experimental | This single-arm study involves three interventions: (A) a co-creation process with 6-8 purposefully selected students and teachers to adapt an existing healthy sleep intervention to local needs; (B) a one-time training for teachers on the importance of sleep and implementation of the intervention, supported by thematic manuals and follow-up consultations; and (C) school-wide implementation of the adapted healthy sleep intervention for all first- and second-year secondary students. Receives: Other: Healthy Sleep Intervention; Other: Co-creation process; Other: Training for teachers |
What is being measured
The primary outcome is the main question the study is designed to answer.
process evaluation of the implementation of a healthy sleep intervention
experiences of students with the received intervention; experiences of students and teachers regarding the participatory adaptation of the intervention; experiences of teachers with the implementation of the intervention.
this will be analysed through interviews and focus groups
Measured: From enrollment to the end of intervention implementation at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benedicte Deforche, Prof. PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030556
- Sponsor's protocol ID
- ONZ-2024-0614
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: it is not necessary to share individual participant data as part of a result of this study.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cascading an Intervention to Promote Healthy Sleep Among Adolescents Following Vocational Education Via a Participatory Approach
- ClinicalTrials.gov ID
- NCT07030556
- Acronym / sponsor ID
- ONZ-2024-0614
- Conditions
- Sleep Quality, Implementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Jun 2025 (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.
Sleep is crucial for the mental, cognitive and physical health of adolescents. However, teenagers in 2024 sleep less and less and their sleep is of poorer quality. It is striking that adolescents who follow vocational education sleep even worse compared to peers who follow a technical or general education. It is therefore important to focus on this risk group of adolescents to reduce health differences. However, there are no previous intervention studies that focused on them.
In previous research, a healthy sleep intervention was already developed, implemented and evaluated in a participatory manner. Within this research, the investigators want to focus on evaluating the process of implementation of this intervention among first and second year secondary school students (12 to 14 year olds) and teachers from vocational education. Based on the results of this process evaluation, the investigators want to deliver this intervention as a ready-made package to Flemish secondary schools.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Sleep Intervention | Experimental | Other: Healthy Sleep Intervention, Other: Co-creation process, Other: Training for teachersThis single-arm study involves three interventions: (A) a co-creation process with 6-8 purposefully selected students and teachers to adapt an existing healthy sleep intervention to local needs; (B) a one-time training for teachers on the importance of sleep and implementation of the intervention, supported by thematic manuals and follow-up consultations; and (C) school-wide implementation of the adapted healthy sleep intervention for all first- and second-year secondary students. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- student in 1st or 2nd year of secondary vocational education
- teacher who helped implement the intervention
Key exclusion criteria (1 listed)
- No students who participated in the co-creation process may participate in the group interview about receiving the intervention.
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 |
|---|---|---|
| Healthy Sleep InterventionThis intervention has a duration of nine weeks and starts with a kick-off event where the students of the action group provide explanations to fellow students. Furthermore, the intervention is structured in five themes of approximately two weeks each: 1) importance of healthy sleep, 2) sleep and wake cycle, 3) screen time, 4) exercise and nutrition and 5) screen use and mental well-being. Three posters are provided for each theme, five to seven Instagram posts and a class discussion. In addition, healthy sleep is explained during the biology lesson. Furthermore, a competition between classes is organized to sleep as well as possible with the help of an app, classes are given a planner to visualize the workload of school tasks, exercise snacks will be introduced during the lessons and students are given a notebook to write things down in case of worrying. Finally, a closing moment is provided. Flyers with information about healthy sleep in young people are distributed to parents. | Other | Healthy Sleep Intervention |
| Co-creation processco-creation process with students and teachers: to adapt the existing intervention to the needs of the school. For this, schools can recruit 6 to 8 students via purposeful sampling to form an action group. They will be asked to participate in two sessions during the lunch break in which 1) the needs of the students at school in relation to healthy sleep are mapped out and the goals of the already developed intervention are supplemented or not based on the needs 2) a choice is made from the already developed intervention components 3) necessary adjustments are made to intervention components. | Other | Healthy Sleep Intervention |
| Training for teachersimplementation of the implementation intervention for teachers. The implementation intervention consists of a one-off training for all teachers of the 1st and 2nd year of secondary school in which the importance of sleep and the intervention and its materials are explained. A manual per theme is then provided to the teachers who will implement components (see also appendix 'Manual Sleep Project'). Consultation moments will be planned in consultation to discuss the progress of the implementation. | Other | Healthy Sleep Intervention |
Primary outcome
process evaluation of the implementation of a healthy sleep intervention
Time frame: From enrollment to the end of intervention implementation at 3 months
experiences of students with the received intervention; experiences of students and teachers regarding the participatory adaptation of the intervention; experiences of teachers with the implementation of the intervention. this will be analysed through interviews and focus groups
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 22 Jun 2025.
- Individual participant dataSharing planned: No. it is not necessary to share individual participant data as part of a result of this study.
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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.
Benedicte Deforche, Prof. PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Sleep Intervention, Co-creation process and Training for teachers in people with Sleep Quality and Implementation, run by University Ghent at 1 site in Belgium.
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 2 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: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ann Vandendriessche, PhD (+3293328393, ann.vandendriessche@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
process evaluation of the implementation of a healthy sleep intervention (time frame: From enrollment to the end of intervention implementation at 3 months). 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 22 Jun 2025.