Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05838339
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2022-11-07
Brief Title:
Are You Daydreaming
Sponsor:
University Ghent
Organization:
University Ghent
Study Overview
Official Title:
Are You Daydreaming Co-creation to Promote Healthy Sleep in Adolescents in a School Context a Health CASCADE Protocol
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Health CASCADE
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
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
Detailed Description:
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 ie 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 staffs 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
In total the intervention in both the co-creation school and the standard implementation school will take 9 weeks
Effect evaluation To test the effect of the intervention students n 378 based on a power analysis performed in R will be invited to take part in three measurements baseline posttest after the intervention and follow-up sixth months after the end of the intervention in all three arms For members of the action group a fourth measure will be administered in-between baseline and posttest to investigate whether the co-creation process itself can lead to changes in specific variables see measures section In order to compare the co-creation process to a standard implementation training this fourth measurement will also be assessed among individuals involved in the implementation in the standard implementation school To objectively measure sleep participants will be asked to wear a GENEActiv device for 7 consecutive days at each of the three measurement points Furthermore participants will be invited to complete a questionnaire This questionnaire will consist of questions about sleep duration sleep quality daytime sleepiness sleep hygiene determinants of sleeping behavior knowledge attitude self-efficacy specifically related to sleeping behavior social influence and social support barriers mental wellbeing and feelings of empowerment and ownership Furthermore SES puberty and BMI will be assessed as important covariates For students who are part of the action group in the co-creation school the questionnaire will also contain questions about general self-efficacy and self-esteem Moreover students who are part of the action group will be invited to complete the whole questionnaire at one additional time point namely after the shortened co-creation process This measurement will enable us to investigate whether students in the action group experience more general self-efficacy and feelings of self-esteem as a result of participation in the co-creation process Parents ideally n 378 one parent of each participating student will be invited to complete questionnaires at the same measurement points as the students in all three arms Parents questionnaire will contain questions about knowledge and attitude about sleep whether parents impose bedtime rules on children or have other supportive strategies and questions regarding self-efficacy in engaging in these supportive strategies Completion of questionnaires for students will take about one lesson 40-50 minutes For parents completion will take about 15 minutes
Process evaluation To evaluate the co-creation process as well as the implementation of the intervention the investigators will use questionnaires interviews and focus groups Students and parents from the action group will be asked to provide a short evaluation after every co-creation session More extensive evaluations focus group will take place half-way during the development of the intervention once the adaptation of the intervention is finished and after the implementation of the intervention is done Fellow students and parents who are not part of the action group will be asked to evaluate the implementation of the intervention as well using a short questionnaire Students will also be invited to take part in focus groups School staff co-creation arm and standard implementation arm will be invited to complete a questionnaire measuring motivation empowerment barriers for implementation and general knowledge about sleep at three time points baseline pre-implementation and after the intervention Completion of questionnaires for school staff will take about 30 minutes Moreover school staff will be invited to take part in focus groups as well These will take place at the same time points as for the students Focus groups will take around 50 minutes one lesson
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 staffs 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
In total the intervention in both the co-creation school and the standard implementation school will take 9 weeks
Effect evaluation To test the effect of the intervention students n 378 based on a power analysis performed in R will be invited to take part in three measurements baseline posttest after the intervention and follow-up sixth months after the end of the intervention in all three arms For members of the action group a fourth measure will be administered in-between baseline and posttest to investigate whether the co-creation process itself can lead to changes in specific variables see measures section In order to compare the co-creation process to a standard implementation training this fourth measurement will also be assessed among individuals involved in the implementation in the standard implementation school To objectively measure sleep participants will be asked to wear a GENEActiv device for 7 consecutive days at each of the three measurement points Furthermore participants will be invited to complete a questionnaire This questionnaire will consist of questions about sleep duration sleep quality daytime sleepiness sleep hygiene determinants of sleeping behavior knowledge attitude self-efficacy specifically related to sleeping behavior social influence and social support barriers mental wellbeing and feelings of empowerment and ownership Furthermore SES puberty and BMI will be assessed as important covariates For students who are part of the action group in the co-creation school the questionnaire will also contain questions about general self-efficacy and self-esteem Moreover students who are part of the action group will be invited to complete the whole questionnaire at one additional time point namely after the shortened co-creation process This measurement will enable us to investigate whether students in the action group experience more general self-efficacy and feelings of self-esteem as a result of participation in the co-creation process Parents ideally n 378 one parent of each participating student will be invited to complete questionnaires at the same measurement points as the students in all three arms Parents questionnaire will contain questions about knowledge and attitude about sleep whether parents impose bedtime rules on children or have other supportive strategies and questions regarding self-efficacy in engaging in these supportive strategies Completion of questionnaires for students will take about one lesson 40-50 minutes For parents completion will take about 15 minutes
Process evaluation To evaluate the co-creation process as well as the implementation of the intervention the investigators will use questionnaires interviews and focus groups Students and parents from the action group will be asked to provide a short evaluation after every co-creation session More extensive evaluations focus group will take place half-way during the development of the intervention once the adaptation of the intervention is finished and after the implementation of the intervention is done Fellow students and parents who are not part of the action group will be asked to evaluate the implementation of the intervention as well using a short questionnaire Students will also be invited to take part in focus groups School staff co-creation arm and standard implementation arm will be invited to complete a questionnaire measuring motivation empowerment barriers for implementation and general knowledge about sleep at three time points baseline pre-implementation and after the intervention Completion of questionnaires for school staff will take about 30 minutes Moreover school staff will be invited to take part in focus groups as well These will take place at the same time points as for the students Focus groups will take around 50 minutes one lesson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None