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Trial registered on ANZCTR


Registration number
ACTRN12611000326998
Ethics application status
Approved
Date submitted
25/03/2011
Date registered
28/03/2011
Date last updated
22/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial assessing the effects of a school-based sleep intervention in Year 6 and 7
students
Scientific title
A randomised controlled trial assessing the effects of a school-based sleep intervention in Year 6 and 7
students to increase sleep knowledge and improve sleep behaviour.
Secondary ID [1] 259856 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Patterns - Includes sleep quantity and sleep quality 265431 0
Sleep Hygiene 265432 0
Physical Activity 265434 0
Attention 265435 0
Anxiety 265436 0
Sleep Knowledge 265437 0
Condition category
Condition code
Public Health 265591 265591 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is based on the Theory of Planned Behaviour. This theory suggests that an individual’s intention to change behaviour is a key deciding factor in whether or not an individual decides to change. This intention is impacted by (1) the individual’s attitudes about changing that behaviour, and (2) the opinions and expectations of significant people in their lives (“subjective norms”). The Theory of Planned Behaviour suggests that if a significant other expects and supports someone to change their behaviour (e.g. parent of a child in this study), the intention and motivation to change will be greater. Therefore the involvement of parents and significant others is critical to the success of the intervention and by doing so has been shown to result in greater engagement and more sustained change.
The intervention therefore seeks to
(1) impart the need for change, and the skills and strategies required to do so, and thereby increase the child‘s intention to change sleep behaviours; and
(2) change social norm expectation by addressing the intervention to whole classes, teachers and parents. The sleep intervention program was developed and tested in a series of pilot studies conducted in 2007.

The intervention content will be delivered over a period of one school term (10 weeks). Teachers will receive three hours’ training in the sleep intervention, and a teacher’s manual with teacher’s notes, explanations, references and resources. At the start of the intervention, parents receive an evidence-based educational booklet regarding children’s sleep recommendations and tips. The students then receive four classroom lessons delivered at weekly intervals, in which their teacher gives a PowerPoint presentation and stimulates classroom discussion of sleep-related topics. Each student also receives a workbook containing an overview of the weekly lessons, in addition to education activities aimed at reinforcing content of the lessons and a sleep diary for self-monitoring sleep behaviour. After the four classroom lessons, students complete a group project, culminating in a community presentation evening where they present their group work to the school and parent community, in addition to receiving an address by a sleep expert. The intervention is supported by a university-based website through which teachers and students can direct enquiries throughout the intervention period.
Intervention code [1] 264273 0
Lifestyle
Intervention code [2] 264274 0
Behaviour
Comparator / control treatment
No Sleep Education package is delivered in class - normal school curriculum is continued.
Control group
Active

Outcomes
Primary outcome [1] 262387 0
Positive changes in sleep patterns - includes sleep quantity and sleep quality.

Sleep patterns will be assessed through actigraphy and sleep self report data collected from the Multimedia Activity Recall for Children and Adolescents (MARCA).

Sleep quality is measured through questionnaires. Sleep self report questionnaire and looking at secondary outcomes listed below.
Timepoint [1] 262387 0
Assessments occur at three timepoints.

Baseline assessment - prior to intervention

Post Intervention - schools are visited somewhere between 5 and 7 weeks after the intervention for the second assessment. The intervention consists of 4 lessons, plus a relaxation lesson. Therefore the second assessment needed to be carried out after 5 weeks. Due to school's other commitments and material restraints, we have allowed up to seven weeks for this one-off second assessment to take place.

Follow Up - The follow up assessment occurs 16-18 weeks after baseline. This is between 11 and 12 weeks after the second assessment. It is a one off assessment for each school. The study aimed to have follow up 12 weeks after intervention was completed, but due to school's other commitments and material restraints, we have allowed 2 weeks flexibility for assessment.
Secondary outcome [1] 273675 0
Positive changes to sleep hygiene - this is assessed through the sleep hygiene index, and also through the child's self report of activities carried out prior to bed on the MARCA.
Timepoint [1] 273675 0
Assessments occur at three timepoints.

Baseline assessment - prior to intervention

Post Intervention - schools are visited somewhere between 5 and 7 weeks after the intervention for the second assessment. The intervention consists of 4 lessons, plus a relaxation lesson. Therefore the second assessment needed to be carried out after 5 weeks. Due to school's other commitments and material restraints, we have allowed up to seven weeks for this one-off second assessment to take place.

Follow Up - The follow up assessment occurs 16-18 weeks after baseline. This is between 11 and 12 weeks after the second assessment. It is a one off assessment for each school. The study aimed to have follow up 12 weeks after intervention was completed, but due to school's other commitments and material restraints, we have allowed 2 weeks flexibility for assessment.
Secondary outcome [2] 273678 0
Positive changes in amount of physical activity - this will be assessed through a child's self report of their daily activities from the MARCA
Timepoint [2] 273678 0
Assessments occur at three timepoints.

Baseline assessment - prior to intervention

Post Intervention - schools are visited somewhere between 5 and 7 weeks after the intervention for the second assessment. The intervention consists of 4 lessons, plus a relaxation lesson. Therefore the second assessment needed to be carried out after 5 weeks. Due to school's other commitments and material restraints, we have allowed up to seven weeks for this one-off second assessment to take place.

Follow Up - The follow up assessment occurs 16-18 weeks after baseline. This is between 11 and 12 weeks after the second assessment. It is a one off assessment for each school. The study aimed to have follow up 12 weeks after intervention was completed, but due to school's other commitments and material restraints, we have allowed 2 weeks flexibility for assessment.
Secondary outcome [3] 273679 0
Increase in reaction time on sustained attention task (PVT). The attention task is measured through a 5 minute psychomotor vigilance attention task.
Timepoint [3] 273679 0
Assessments occur at three timepoints.

Baseline assessment - prior to intervention

Post Intervention - schools are visited somewhere between 5 and 7 weeks after the intervention for the second assessment. The intervention consists of 4 lessons, plus a relaxation lesson. Therefore the second assessment needed to be carried out after 5 weeks. Due to school's other commitments and material restraints, we have allowed up to seven weeks for this one-off second assessment to take place.

Follow Up - The follow up assessment occurs 16-18 weeks after baseline. This is between 11 and 12 weeks after the second assessment. It is a one off assessment for each school. The study aimed to have follow up 12 weeks after intervention was completed, but due to school's other commitments and material restraints, we have allowed 2 weeks flexibility for assessment.
Secondary outcome [4] 273680 0
Increase in quality of life scores - this will be assessed through the Child Health utility 9D questionnaire (CHU9D).
Timepoint [4] 273680 0
Assessments occur at three timepoints.

Baseline assessment - prior to intervention

Post Intervention - schools are visited somewhere between 5 and 7 weeks after the intervention for the second assessment. The intervention consists of 4 lessons, plus a relaxation lesson. Therefore the second assessment needed to be carried out after 5 weeks. Due to school's other commitments and material restraints, we have allowed up to seven weeks for this one-off second assessment to take place.

Follow Up - The follow up assessment occurs 16-18 weeks after baseline. This is between 11 and 12 weeks after the second assessment. It is a one off assessment for each school. The study aimed to have follow up 12 weeks after intervention was completed, but due to school's other commitments and material restraints, we have allowed 2 weeks flexibility for assessment.
Secondary outcome [5] 311006 0
Sleep knowledge - this will be assessed through a previously trialled, 15-item true or false sleep knowledge questionnaire. This questionnaire has not been validated at this time, but has been used in previous trials of the ACES sleep education program.
Timepoint [5] 311006 0
Assessments occur at three timepoints. Baseline assessment - prior to intervention Post Intervention - schools are visited somewhere between 5 and 7 weeks after the intervention for the second assessment. The intervention consists of 4 lessons, plus a relaxation lesson. Therefore the second assessment needed to be carried out after 5 weeks. Due to school's other commitments and material restraints, we have allowed up to seven weeks for this one-off second assessment to take place. Follow Up - The follow up assessment occurs 16-18 weeks after baseline. This is between 11 and 12 weeks after the second assessment. It is a one off assessment for each school. The study aimed to have follow up 12 weeks after intervention was completed, but due to school's other commitments and material restraints, we have allowed 2 weeks flexibility for assessment.
Secondary outcome [6] 311007 0
Intention to change behaviour - this will be assessed through a questionnaire entitled 'Bedtime Habits Questionnaire' based on the Theory of Planned behaviour variables. This questionnaire has not been validated at this time.
Timepoint [6] 311007 0
Assessments occur at three timepoints. Baseline assessment - prior to intervention Post Intervention - schools are visited somewhere between 5 and 7 weeks after the intervention for the second assessment. The intervention consists of 4 lessons, plus a relaxation lesson. Therefore the second assessment needed to be carried out after 5 weeks. Due to school's other commitments and material restraints, we have allowed up to seven weeks for this one-off second assessment to take place. Follow Up - The follow up assessment occurs 16-18 weeks after baseline. This is between 11 and 12 weeks after the second assessment. It is a one off assessment for each school. The study aimed to have follow up 12 weeks after intervention was completed, but due to school's other commitments and material restraints, we have allowed 2 weeks flexibility for assessment.

Eligibility
Key inclusion criteria
Participants need to be in a year 6 or 7 class at a school.

They must be in the age range of 10-13 years old.

Participants are required to have competent English language skills.

Participants require sufficient cognitive ability to understand the questionnaires. For this reason special schools will not be considered for this study.
Minimum age
10 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-English Speaking.
Participants not within the age range, and not attending school.
Participants attending special need schools.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
School children in years 6 and 7 will be targeted. Twelve schools will be selected at random across socio-economic position tertiles, as quantified by School Card Register. Within each school, one class of Year 6, Year 7 or composite Year 6-7 students will be randomly selected to participate. We anticipate that there will be on average 30 students per class, yielding a total of 360 participants. A list of schools will be generated with the assistance of the Department of Education (DECS) and Catholic Education Office (CEO) and recruitment will continue until the target population is met. Allocation to treatment will be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Schools for this study were randomly chosen from a pool of Government, Independent and Catholic Adelaide Metropolitan and surrounding schools (postcodes of 5000 to 5199, inclusive) which had at least one Year 6 and/or Year 7 class (R-6, R-7, 3-7, 7-12 and R-12). Single sex schools were excluded as this may have skewed the gender distribution of students in the cohort. Schools with less than an estimated minimum of 25 students in each class were also excluded (i.e. a minimum of 200 students in an R-7 school, 165 students in a 3-7 school, 325 students in an R-12 school). The Schools remaining after these two exclusion procedures were then ranked in order of their Index of Community Socio-Educational Advantage (ICSEA)* obtained from the My School website (www.myschool.edu.au, accessed 24 Aug 2010), an Australian Curriculum, Assessment and Reporting Authority (ACARA) information service. The ranked list was then divided into equal tertiles (76 or 77 schools in each). For each tertile list, the schools were listed alphabetically and a generated random number sequence (www.random.org, accessed 24 Aug 2010) used to list the schools in random order. For each tertile a random number sequence of 2 was generated and applied repeatedly to the three tertile lists to allocate school to either intervention or control (1 representing intervention, 2 representing control). Letters were then sent to the top 20 schools in each tertile list inviting them to participate in the study. Follow up phone calls were made to the schools in the weeks following the initial letters of invitation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/03/2011
Actual
9/05/2011
Date of last participant enrolment
Anticipated
Actual
30/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 3874 0
5159
Recruitment postcode(s) [2] 3875 0
5062
Recruitment postcode(s) [3] 3876 0
5162
Recruitment postcode(s) [4] 3877 0
5125
Recruitment postcode(s) [5] 3878 0
5020

Funding & Sponsors
Funding source category [1] 264728 0
Government body
Name [1] 264728 0
Australian Research Council
Country [1] 264728 0
Australia
Primary sponsor type
Government body
Name
SA Health
Address
Government of South Australia
Adelaide, SA 5000
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 263855 0
University
Name [1] 263855 0
University of South Australia
Address [1] 263855 0
North Terrace, Adelaide
South Australia 5000
Australia
Country [1] 263855 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266717 0
Department of Education and Children's Services (DECS)
Ethics committee address [1] 266717 0
Ethics committee country [1] 266717 0
Australia
Date submitted for ethics approval [1] 266717 0
Approval date [1] 266717 0
Ethics approval number [1] 266717 0
Ethics committee name [2] 266718 0
Catholic Education Board
Ethics committee address [2] 266718 0
Ethics committee country [2] 266718 0
Australia
Date submitted for ethics approval [2] 266718 0
Approval date [2] 266718 0
Ethics approval number [2] 266718 0
Ethics committee name [3] 266719 0
University of South Australia
Ethics committee address [3] 266719 0
Ethics committee country [3] 266719 0
Australia
Date submitted for ethics approval [3] 266719 0
Approval date [3] 266719 0
25/02/2011
Ethics approval number [3] 266719 0
Ethics committee name [4] 291841 0
Central Queensland University
Ethics committee address [4] 291841 0
Ethics committee country [4] 291841 0
Australia
Date submitted for ethics approval [4] 291841 0
Approval date [4] 291841 0
Ethics approval number [4] 291841 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32385 0
A/Prof Sarah Blunden
Address 32385 0
Appleton Institute
Central Queensland University
44 Greenhill Road
Wayville, SA, 5034
Country 32385 0
Australia
Phone 32385 0
+61 8 8378 4513
Fax 32385 0
Email 32385 0
[email protected]
Contact person for public queries
Name 15632 0
Sarah Blunden
Address 15632 0
Appleton Institute
Central Queensland University
44 Greenhill Road
Wayville, SA, 5034
Country 15632 0
Australia
Phone 15632 0
+61 8 8378 4513
Fax 15632 0
Email 15632 0
[email protected]
Contact person for scientific queries
Name 6560 0
Sarah Blunden
Address 6560 0
Appleton Institute
Central Queensland University
44 Greenhill Road
Wayville, SA, 5034
Country 6560 0
Australia
Phone 6560 0
+61 8 8378 4513
Fax 6560 0
Email 6560 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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