跳至主要内容
临床试验/NCT05838339
NCT05838339已完成不适用

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

University Ghent2 个研究点 分布在 1 个国家目标入组 382 人开始时间: 2022年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
382
试验地点
2
主要终点
Sleep quality - daytime sleepiness

研究概览

简要总结

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.

详细描述

The aim of this study is to scale up an existing sleep intervention (co-created with adolescents and parents, and implemented with the support of teachers and fellow students) in Flanders to improve sleeping behavior. Scaling up an intervention is defined as transferring an intervention to another context, setting, and group. As co-created interventions are localized by nature, the researchers will investigate whether this existing intervention can be scaled up to a new context, setting, and group while the aim of the intervention remains the same, i.e., improving healthy sleeping behavior in adolescents. To test this, a co-creation school, standard implementation school, and control school will be recruited. Below, the investigators will describe what will be expected from each condition.

Co-creation school: Scaling up the existing sleep intervention to a new context, setting, and group will proceed in the co-creation school. The existing intervention will be adapted to the culture of this school, based on students', school staff's, and parents' perspective on the health problem (unhealthy sleeping behavior in adolescents) and thoughts on the components of the existing intervention. To adapt the existing sleep intervention, action groups will be composed. Every action group contains a maximum of 10 individuals.

  • Action group adolescents: This action group consists of a maximum of 10 students from the 6th and 7th grade (1st grade secondary school, Belgian school system). The participants will be involved in the adaptation of existing intervention components. Furthermore, participants will implement the adapted intervention at school.
  • Action group school staff: This action group consists of a maximum of 10 individuals working at the co-creation school. Participants will be involved in designing an implementation plan for the intervention. Moreover, participants will be asked to check the adapted components for feasibility.
  • Action group parents: This action group consists of a maximum of 10 parents who have at least one child in the 6th or 7th grade of the co-creation school. Parents will be involved in the adaptation of the parental intervention components of the existing intervention.
  • Co-facilitators: Students of the 12th grade (year 6 secondary school, Belgian school system) will be involved as co-facilitators. This means that the students of the 12th grade will facilitate the co-creation sessions designed for the students of the 6th and 7th grade together with the researchers.

Standard implementation school: To test the added value of the shortened co-creation process and to show that this process is needed to build ownership and empowerment, the existing sleep intervention will be implemented without the shortened co-creation process. The standard implementation school will be provided with a manual and a training about the implementation of the intervention.

Control school: To test the overall effect of the intervention a control group is needed. None of the interventions will be implemented at the control school and therefore the school staff do not have to take part in the measurements.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
11 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Sleep quality - daytime sleepiness

时间窗: 6 months after the intervention

Will be assessed using the Pediatric Daytime Sleepiness Scale

Sleep quality school days - SOL

时间窗: 6 months after the intervention

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

Objective sleep quantity free days

时间窗: 6 months after the intervention

Will be assessed objectively using actigraphy (GENEActivs)

Sleep quality - general

时间窗: 6 months after the intervention

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

Sleep quality free days - SOL

时间窗: 6 months after the intervention

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

Objective sleep quality

时间窗: 6 months after the intervention

Will be assessed objectively using actigraphy (GENEActivs)

Sleep quantity school days

时间窗: 6 months after the intervention

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).

Sleep quantity free days

时间窗: 6 months after the intervention

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).

Objective sleep quantity school days

时间窗: 6 months after the intervention

Will be assessed objectively using actigraphy (GENEActivs)

次要结局

  • Determinants of sleeping behavior(6 months after the intervention)
  • Empowerment(6 months after the intervention)
  • Self-esteem(6 months after the intervention)
  • Motivation for implementation(Immediately after the intervention)
  • Mental wellbeing(6 months after the intervention)
  • Self-efficacy(6 months after the intervention)
  • Barriers for implementation(Immediately after the intervention)
  • General motivation(Immediately after the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验