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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]

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

Sleep Hygiene

Physical Activity

Attention

Anxiety

Sleep Knowledge

Condition category

Condition code

Public Health

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]

Lifestyle

Intervention code [2]

Behaviour

Comparator / control treatment

No Sleep Education package is delivered in class - normal school curriculum is continued.

Control group

Active

Outcomes

Primary outcome [1]

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]

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]

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]

Secondary outcome [2]

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]

Secondary outcome [3]

Increase in reaction time on sustained attention task (PVT). The attention task is measured through a 5 minute psychomotor vigilance attention task.

Timepoint [3]

Secondary outcome [4]

Increase in quality of life scores - this will be assessed through the Child Health utility 9D questionnaire (CHU9D).

Timepoint [4]

Secondary outcome [5]

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]

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]

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]

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)

Recruitment postcode(s) [1]

5159

Recruitment postcode(s) [2]

5062

Recruitment postcode(s) [3]

5162

Recruitment postcode(s) [4]

5125

Recruitment postcode(s) [5]

5020

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Research Council

Address [1]

Level 2, 11 Lancaster Place
Majura Park ACT 2609
AUSTRALIA

Country [1]

Australia

Primary sponsor type

Government body

Name

SA Health

Address

Government of South Australia
Adelaide, SA 5000
AUSTRALIA

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of South Australia

Address [1]

North Terrace, Adelaide
South Australia 5000
Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Department of Education and Children's Services (DECS)

Ethics committee address [1]

31 Flinders Street 
ADELAIDE SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

Catholic Education Board

Ethics committee address [2]

39 Wakefield Street, Adelaide, SA 5000

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

Ethics committee name [3]

University of South Australia

Ethics committee address [3]

Research and Innovation Services 
Mawson Lakes Campus 
Mawson Lakes Boulevard 
Mawson Lakes  SA  5095

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

25/02/2011

Ethics approval number [3]

Ethics committee name [4]

Central Queensland University

Ethics committee address [4]

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

Approval date [4]

Ethics approval number [4]

Summary

Brief summary

Children’s sleep duration has been decreasing in recent decades, and the average Australian child is not getting
enough sleep for optimal well-being, health and social function. This study will use a randomised controlled trial
to test the effect of a comprehensive sleep intervention delivered in a school setting. It is hypothesised that the
intervention will improve children’s attitudes and knowledge, mediating changes in sleep behaviour. In turn, this may affect alertness, quality of life, and use-of-time. This is the first sleep behaviour intervention delivered in a community setting. If successful, it could inform curriculum change, with the potential to address a
wide range of cognitive, affective and physical outcomes.

Trial website

Trial related presentations / publications

Rigney G, Blunden S, Maher C, Olds T (2014) Can a sleep education program improve sleep behaviour and health-related quality of life in Australian school children? International Conference on Health, Wellness & Society, Vancouver, March 2014. 

Rigney G, Olds T, Maher C, Blunden S (2013) Can sleep education improve pre-adolescent sleep? Sleep and Biological Rhythms, 11:2, p.70.

Rigney G, Olds T, Maher C, Petkov J, Blunden S (2012) Sleep education is successful in increasing time in bed: Promising results for sleep health. International Paediatric Sleep Association Congress, Manchester December 2012, p. 170.

Rigney G, Olds T, Maher C, Petkov J, Blunden S (2012) Does sleep education lead to changes in sleep duration? Sleep and Biological Rhythms. 10:1, p. 37.

Etherton H, Blunden S, Rigney G (2011) Sleep and health-related quality of life in South Australian year 6-7 children before and after a sleep education program. World Association of Sleep Medicine, Quebec City September  2011, p.123.

Rigney G, Blunden S, Etherton H, Olds T, Maher C (2011) What components of sleep education are needed to bring about behavioural change? World Association of Sleep Medicine, Quebec City September 2011, p. 109.

Public notes

Contacts

Principal investigator

Name

A/Prof Sarah Blunden

Address

Appleton Institute
Central Queensland University
44 Greenhill Road
Wayville, SA, 5034

Country

Australia

Phone

+61 8 8378 4513

Fax

[email protected]

Contact person for public queries

Name

Sarah Blunden

Address

Appleton Institute
Central Queensland University
44 Greenhill Road
Wayville, SA, 5034

Country

Australia

Phone

+61 8 8378 4513

Fax

[email protected]

Contact person for scientific queries

Name

Sarah Blunden

Address

Appleton Institute
Central Queensland University
44 Greenhill Road
Wayville, SA, 5034

Country

Australia

Phone

+61 8 8378 4513

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically