NCT04669236

Brief Summary

Adolescent sleep deprivation is becoming increasingly recognized internationally as a significant health concern. This project will be the first to use a unique approach of actively involving adolescents as real life experts in the development of interventions to improve sleep behaviour (using a participatory health research methodology) and to evaluate the effectiveness of these interventions (using a randomised controlled trial).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,044

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2018

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

3.5 years

First QC Date

November 12, 2018

Last Update Submit

February 15, 2023

Conditions

Sleep

Keywords

Sleep behaviourAdolescentsParticipatory health researchIntervention

Outcome Measures

Primary Outcomes (2)

  • Sleep duration as assesed by the Munich Chronotype Questionnaire for children

    to ask about students' sleep habits over the past 2 weeks, differentiating between sleep on school nights (Sunday to Thursday) and weekend nights (Friday and Saturday). Students will be asked to report their typical go to bed time, lights-out time, sleep onset latency, total sleep time, wake-up time, and out of bed time. This questionnaire showed good validity against objective sleep measures (i.e., actigraphy).

    2 years

  • Sleep quality as assesed by the short Adolescent Sleep Wake Scale

    10 questions on sleep quality and sleep habbits, topics are: going to bed, during the night and waking up

    2 years

Secondary Outcomes (4)

  • Sleep knowledge

    2 years

  • Sleep hygiene

    2 years

  • Daytime sleepiness

    2 years

  • Socio-demographic and theory-based psychosocial correlates

    2 years

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention promoting healthy sleep behaviour in adolescents based on a participatory health research approach. Based on participatory session, the pupils of the action group will develop the intervention. They will participate in every step of the development to maximize their input.

Behavioral: Intervention to promote healthy sleep behavior

Control group

NO INTERVENTION

Participants in the control group will receive no intervention.

Interventions

Intervention to promote healthy sleep behaviorBEHAVIORAL

An action group (6 - 8 pupils) was conducted at each school. Brainstorm sessions about effective strategies to change sleeping behavior in this population were held. Strategies, perceived as effective by the target population, will be summarized in an overview. Also feedback of adolescent, who are not part of the action group, will be asked. After feedback, the intervention will be developed by the intervention schools. Thereby, three different intervention strategies will be implemented and tested (one intervention at each school) to meet the individuals needs of each school. The action groups will develop the intervention materials during sessions this year. Afterwards, they will implement the intervention themselves in collaboration with teachers of the school and the researchers.

Intervention group

Eligibility Criteria

Age13 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Between 13 and 16 years old
  • Dutch speaking
  • Education: ASO (General Secondary Education), TSO (Technical Secondary Education) or BSO (Vocational Secondary Education)

You may not qualify if:

  • Having a sleeping disorder
  • BUSO (Special Secondary Education)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University-Public Health Department

Ghent, East-Flanders, 9000, Belgium

Location

Related Publications (1)

  • Vandendriessche A, Deforche B, Dhondt K, Verloigne M, Van Cauwenberg J. Effect evaluation of a participatory developed school-based healthy sleep intervention for adolescents. Health Psychol. 2025 Apr;44(4):380-390. doi: 10.1037/hea0001443. Epub 2025 Jan 27.

    PMID: 39869691DERIVED

Study Officials

  • Benedicte Deforche

    University Ghent

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Pre, post and follow-up testing with 3 intervention and 6 control schools
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2018

First Posted

December 16, 2020

Study Start

June 25, 2017

Primary Completion

December 31, 2020

Study Completion

January 15, 2021

Last Updated

February 16, 2023

Record last verified: 2023-02

Locations

BE(1)