CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 382 enrolled
Drug / intervention
Healthy Sleep Interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05838339
NCT05838339N/ACompleted

Are You Daydreaming? Co-creation to Promote Healthy Sleep in Adolescents in a School Context: a Health CASCADE Protocol

University Ghent·interventional·Posted May 1, 2023·Updated Oct 1, 2024

In Brief

A clinical study evaluating Healthy Sleep Intervention for Sleep Hygiene and 2 related conditions. Completed, enrolled 382 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
CollaboratorsEuropean Commission

Timeline

N/ACompletedFinished
2023202420252026
First PostedMay 1, 2023
Enrollment StartOct 4, 2022
Primary CompletionNov 24, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 3.2 years ago

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.