NCT05838339

Brief Summary

Health CASCADE (Marie Skłodowska-Curie grant agreement n° 956501) aims to address complex public health problems by making co-creation a scientifically sound methodology, aided by evidence-based methods, practices, and technologies. The current study, which focuses on co-creation in the school context is part of this overarching European project. Healthy sleep is important for adolescents' mental and physical health and cognitive functioning. However, sleep difficulties are among the top three health complaints in European adolescents. This indicates a need for successful interventions. Co-creation is a promising approach to design tailored interventions. By actively involving all relevant stakeholders, co-creation has been shown to increase self-efficacy, self-consciousness, empowerment, and feelings of ownership. However, co-created interventions are localized and therefore less generalizable to a broader population. Moreover, the process is very time- and cost- consuming. To make co-creation more feasible, research should focus on the upscaling of existing interventions. The investigators propose that the co-creation process is still absolutely vital for intervention success but that it can be shortened. The investigators aim to scale up an existing intervention to promote healthy sleep. This existing intervention was developed using co-creation together with the target group (adolescents aged 13 to 15) and parents, and implemented with support of teachers and fellow students. To investigate whether the shorter co-creation process is needed in order to scale up the intervention to another setting and context, the investigators will use a three-arm cluster controlled trial. This will include one co-creation intervention school, one standard implementation school (this school receives the existing intervention without a shortened co-creation process), and one control school. The co-creation process will be structured by using the Intervention Mapping Protocol to ensure an evidence-based framework. The effect of the intervention will be evaluated using actigraphy and questionnaires, while the process will be evaluated using questionnaires, interviews, and focus groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
382

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

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

October 4, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 7, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2023

Completed
Last Updated

October 1, 2024

Status Verified

June 1, 2024

Enrollment Period

1.1 years

First QC Date

November 7, 2022

Last Update Submit

September 26, 2024

Conditions

Sleep HygieneSleepPoor Quality Sleep

Keywords

AdolescenceSleeping behaviorCo-creationSchool-based interventionSchool staffParentsMental HealthSleepMotivationOwnershipHealth Promotion

Outcome Measures

Primary Outcomes (36)

  • Sleep quantity school days

    Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4).

    Baseline

  • Sleep quantity free days

    Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4).

    Baseline

  • Sleep quantity school days

    Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4). The pre-intervention assessment will only be done for members of the action group.

    Pre-intervention, after the co-creation process

  • Sleep quantity free days

    Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4). The pre-intervention assessment will only be done for members of the action group.

    Pre-intervention, after the co-creation process

  • Sleep quantity school days

    Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4).

    Immediately after the intervention

  • Sleep quantity free days

    Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4).

    Immediately after the intervention

  • Sleep quantity school days

    Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4).

    6 months after the intervention

  • Sleep quantity free days

    Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4).

    6 months after the intervention

  • Objective sleep quantity school days

    Will be assessed objectively using actigraphy (GENEActivs)

    Baseline

  • Objective sleep quantity free days

    Will be assessed objectively using actigraphy (GENEActivs)

    Baseline

  • Objective sleep quantity school days

    Will be assessed objectively using actigraphy (GENEActivs). The pre-intervention assessment will only be done for members of the action group.

    Pre-intervention, after the co-creation process

  • Objective sleep quantity free days

    Will be assessed objectively using actigraphy (GENEActivs). The pre-intervention assessment will only be done for members of the action group.

    Pre-intervention, after the co-creation process

  • Objective sleep quantity school days

    Will be assessed objectively using actigraphy (GENEActivs)

    Immediately after the intervention

  • Objective sleep quantity free days

    Will be assessed objectively using actigraphy (GENEActivs)

    Immediately after the intervention

  • Objective sleep quantity school days

    Will be assessed objectively using actigraphy (GENEActivs)

    6 months after the intervention

  • Objective sleep quantity free days

    Will be assessed objectively using actigraphy (GENEActivs)

    6 months after the intervention

  • Sleep quality - general

    Will be assessed using the short form of the Adolescent Sleep Wake Scale (s-ASWS)

    Baseline

  • Sleep quality - daytime sleepiness

    Will be assessed using the Pediatric Daytime Sleepiness Scale (PDSS)

    Baseline

  • Sleep quality school days - SOL

    Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ

    Baseline

  • Sleep quality free days - SOL

    Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ

    Baseline

  • Objective sleep quality

    Will be assessed objectively using actigraphy (GENEActivs)

    Baseline

  • Sleep quality - general

    Will be assessed using the short form of the Adolescent Sleep Wake Scale (s-ASWS). The pre-intervention assessment will only be done for members of the action group.

    Pre-intervention, after the co-creation process

  • Sleep quality - daytime sleepiness

    Will be assessed using the Pediatric Daytime Sleepiness Scale (PDSS). The pre-intervention assessment will only be done for members of the action group.

    Pre-intervention, after the co-creation process

  • Sleep quality school days - SOL

    Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ. The pre-intervention assessment will only be done for members of the action group.

    Pre-intervention, after the co-creation process

  • Sleep quality free days - SOL

    Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ. The pre-intervention assessment will only be done for members of the action group.

    Pre-intervention, after the co-creation process

  • Objective sleep quality

    Will be assessed objectively using actigraphy (GENEActivs). The pre-intervention assessment will only be done for members of the action group.

    Pre-intervention, after the co-creation process

  • Sleep quality - general

    Will be assessed using the short form of the Adolescent Sleep Wake Scale (s-ASWS).

    Immediately after the intervention

  • Sleep quality - daytime sleepiness

    Will be assessed using the Pediatric Daytime Sleepiness Scale (PDSS)

    Immediately after the intervention

  • Sleep quality school days - SOL

    Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ

    Immediately after the intervention

  • Sleep quality free days - SOL

    Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ

    Immediately after the intervention

  • Objective sleep quality

    Will be assessed objectively using actigraphy (GENEActivs)

    Immediately after the intervention

  • Sleep quality - general

    Will be assessed using the short form of the Adolescent Sleep Wake Scale (s-ASWS)

    6 months after the intervention

  • Sleep quality - daytime sleepiness

    Will be assessed using the Pediatric Daytime Sleepiness Scale

    6 months after the intervention

  • Sleep quality school days - SOL

    Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ

    6 months after the intervention

  • Sleep quality free days - SOL

    Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ

    6 months after the intervention

  • Objective sleep quality

    Will be assessed objectively using actigraphy (GENEActivs)

    6 months after the intervention

Secondary Outcomes (29)

  • Determinants of sleeping behavior

    Baseline

  • Determinants of sleeping behavior

    Pre-intervention, after the co-creation process

  • Determinants of sleeping behavior

    Immediately after the intervention

  • Determinants of sleeping behavior

    6 months after the intervention

  • Mental wellbeing

    Baseline

  • +24 more secondary outcomes

Study Arms (3)

Co-creation School

EXPERIMENTAL

An existing healthy sleep intervention will be scaled up using a shortened co-creation process. An effect- and process evaluation will be performed.

Behavioral: Healthy Sleep Intervention

Standard Implementation School

ACTIVE COMPARATOR

The existing healthy sleep intervention will be implemented without using a co-creation approach. An effect- and process evaluation will be performed.

Behavioral: Healthy Sleep Intervention

Control School

NO INTERVENTION

No intervention will be implemented. An effect evaluation will be performed.

Interventions

Healthy Sleep InterventionBEHAVIORAL

The existing intervention consists of the following components: Posters, Instagram, kick-off event, flyer for parents, parents-teacher conference, class discussions, app, classes on sleep (and relaxation), blue lights installations, alarm clocks and t-shirts, T-days without phone in the bedroom (Tuesdays and Thursdays), class competition.

Co-creation SchoolStandard Implementation School

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Students must be aged between 11 and 13 years. Parents must have at least one child in the 6th or 7th Grade of the participating school.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, East Flanders, 9000, Belgium

Location

Related Publications (10)

  • Drake C, Nickel C, Burduvali E, Roth T, Jefferson C, Pietro B. The pediatric daytime sleepiness scale (PDSS): sleep habits and school outcomes in middle-school children. Sleep. 2003 Jun 15;26(4):455-8.

    PMID: 12841372BACKGROUND

  • Leask CF, Sandlund M, Skelton DA, Altenburg TM, Cardon G, Chinapaw MJM, De Bourdeaudhuij I, Verloigne M, Chastin SFM; GrandStand, Safe Step and Teenage Girls on the Move Research Groups. Framework, principles and recommendations for utilising participatory methodologies in the co-creation and evaluation of public health interventions. Res Involv Engagem. 2019 Jan 9;5:2. doi: 10.1186/s40900-018-0136-9. eCollection 2019.

    PMID: 30652027BACKGROUND

  • Roenneberg T, Keller LK, Fischer D, Matera JL, Vetter C, Winnebeck EC. Human activity and rest in situ. Methods Enzymol. 2015;552:257-83. doi: 10.1016/bs.mie.2014.11.028. Epub 2015 Jan 5.

    PMID: 25707281BACKGROUND

  • Sufrinko AM, Valrie CR, Lanzo L, Bond KE, Trout KL, Ladd RE, Everhart DE. Empirical validation of a short version of the Adolescent Sleep-Wake Scale using a sample of ethnically diverse adolescents from an economically disadvantage community. Sleep Med. 2015 Oct;16(10):1204-6. doi: 10.1016/j.sleep.2015.07.002. Epub 2015 Jul 15.

    PMID: 26429746BACKGROUND

  • Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.

    PMID: 18042300BACKGROUND

  • Vandendriessche A, Dierckens M, Delaruelle K, Deforche B. How Are Adolescents Sleeping? Conservative Estimates of Sleep Duration Underestimate the Problem. J Adolesc Health. 2021 Apr;68(4):830. doi: 10.1016/j.jadohealth.2020.12.137. No abstract available.

    PMID: 33781473BACKGROUND

  • Wood C, Griffin M, Barton J, Sandercock G. Modification of the Rosenberg Scale to Assess Self-Esteem in Children. Front Public Health. 2021 Jun 17;9:655892. doi: 10.3389/fpubh.2021.655892. eCollection 2021.

    PMID: 34222169BACKGROUND

  • Soenens, B., Sierens, E., Vansteenkiste, M., Dochy, F., & Goossens, L. (2012). Psychologically controlling teaching: Examining outcomes, antecedents, and mediators. Journal of Educational Psychology, 104(1), 108-120. https://doi.org/10.1037/a0025742

    BACKGROUND

  • Blais, M. R., Brière, N. M., Lachance, L., & Riddle, A. S. (1993). L'inventaire des motivations au travail de Blais. Revue québécoise de psychologie.

    BACKGROUND

  • Delfmann LR, Vandendriessche A, de Boer J, Cardon G, Hunter SC, Dhondt K, Verloigne M, Deforche B. Co-adapting a healthy sleep intervention with adolescents: impact and process evaluation of a Health CASCADE pilot study. BMC Public Health. 2025 Nov 22;25(1):4411. doi: 10.1186/s12889-025-25412-2.

    PMID: 41275198DERIVED

Related Links

MeSH Terms

Conditions

Sleep HygienePsychological Well-Being

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorPersonal Satisfaction

Study Officials

  • Maïté Verloigne, Prof. dr.

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The investigators aim to conduct a pilot three-arm controlled trial with a mixed methods approach. Schools will be assigned to one of three groups: 1) co-creation intervention group (shortened co-creation process), 2) standard implementation group (no co-creation process), and 3) control group. After the implementation of the intervention, effect and process will be evaluated.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2022

First Posted

May 1, 2023

Study Start

October 4, 2022

Primary Completion

November 24, 2023

Study Completion

November 24, 2023

Last Updated

October 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

The investigators plan to share pseudonymized data within the Health CASCADE consortium and with fellow colleagues within the research group for secondary data analyses and teaching purposes. However, participants must re-consent for the use of their data in a new research project and domain.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data collection will take place from October 2022 until November 2023, afterwards data will be pseudonymised and shared. As Health CASCADE is a project that supports open science pseudonymised data will be available for the persons specified above forever.
Access Criteria
Everyone that possess the URL to the Zenodo Health CASCADE page can access the pseudonymized data files.
More information

Locations

BE(1)