NCT07030556

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Jun 2025Jun 2026

First Submitted

Initial submission to the registry

June 4, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

June 4, 2025

Last Update Submit

June 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    From enrollment to the end of intervention implementation at 3 months

Study Arms (1)

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.

Other: Healthy Sleep InterventionOther: Co-creation processOther: Training for teachers

Interventions

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.

Healthy Sleep Intervention

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.

Healthy Sleep Intervention

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.

Healthy Sleep Intervention

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • student in 1st or 2nd year of secondary vocational education
  • teacher who helped implement the intervention

You may not qualify if:

  • No students who participated in the co-creation process may participate in the group interview about receiving the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Benedicte Deforche, Prof. PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Vandendriessche, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2025

First Posted

June 22, 2025

Study Start

June 30, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

June 22, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

it is not necessary to share individual participant data as part of a result of this study.

Locations