Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000975796
Ethics application status
Not yet submitted
Date submitted
29/08/2013
Date registered
2/09/2013
Date last updated
2/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of school-based sleep education programs: Does reducing barriers to change and increasing supports improve outcomes?
Scientific title
An evaluation of school-based sleep education programs for high school students: Does reducing barriers to change and increasing supports improve sleep and mood?
Secondary ID [1] 283105 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescents' sleep 289946 0
Mood 289947 0
Condition category
Condition code
Mental Health 290320 290320 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 290321 290321 0 0
Depression
Public Health 290340 290340 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be four interventions (1) Classes-As-Usual which will be our control group where teenagers will go to their regular classes that do not involve information on sleep; (2) Sleep Education Class plus Parental Involvement (SEC + P) will include Sleep Education Classes (SEC) which is a replication of that described in Cain, Gradisar, Moseley (2011) Sleep Med, 12, 246-251, plus Parent Sleep Education. This is a 4 x 50-min program, 1 class per week over 4 weeks, teaching teenagers the importance of sleep and that regularising their sleep patterns can help to achieve better sleep, but also provide parents with 4 short videos (5-min) describing what their teenage children have learned in class and how they can support them change their behaviours. Parent videos are provided once weekly after their teen's class; (3) Sleep Education Class plus Light Therapy (SEC + L) will be the same as (SEC) but also provide the teenagers with light glasses (Re-Timers) to assist them in regularising their sleep patterns. Teens will use the green light glasses (495nm, 65 IW/cm2) for 1 hour per day in the 3rd week of the education program; (4) Sleep Education Class plus Parental Involvement plus Light Therapy will involve Sleep Education Classes, Parent Sleep Education, and use of the Light Glasses. Compliance with wearing the light glasses will be recorded on the adolescents' sleep diary for that week.
Intervention code [1] 287822 0
Behaviour
Comparator / control treatment
The Classes-As-Usual group will be the control group.
Control group
Active

Outcomes
Primary outcome [1] 290357 0
Sleep pattern regularisation (i.e., bedtime and wake times are more consistent across the 7-day week). This will be assessed using a retrospective questionnaire for the past week's sleep developed specifically for these type of studies by the researchers, and previously reported in published trials (see Moseley & Gradisar, Sleep, 2009, v32, and Cain, Gradisar & Moseley, Sleep Med, 2011, v12.
Timepoint [1] 290357 0
Post-education and 6-week follow-up
Secondary outcome [1] 304355 0
Mood symptoms assessed with the Short Mood and Feelings Questionnaire.
Timepoint [1] 304355 0
Post-Education and 6-week follow-up

Eligibility
Key inclusion criteria
Year 11 students will be included.
Minimum age
15 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 287860 0
University
Name [1] 287860 0
Flinders University
Country [1] 287860 0
Australia
Primary sponsor type
Individual
Name
Michael Gradisar
Address
Flinders University
School of Psychology
GPO Box 2100
Adelaide
SA 5001
Country
Australia
Secondary sponsor category [1] 286589 0
Individual
Name [1] 286589 0
Daniel Bonnar
Address [1] 286589 0
Flinders University
School of Psychology,
GPO Box 2011,
Adelaide, S.A.
5001
Country [1] 286589 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289803 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 289803 0
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Ethics committee country [1] 289803 0
Australia
Date submitted for ethics approval [1] 289803 0
06/09/2013
Approval date [1] 289803 0
Ethics approval number [1] 289803 0

Summary
Brief summary
This study will evaluate the effectiveness of sleep education classes for high school students. As teenagers typically have a sleep pattern where they fall asleep late and wake up late, and which conflicts with getting up for school, this study will test 3 versions of sleep education classes against a control group (normal classes). These are: sleep education classes plus parent sleep education (SEC + P), sleep education classes plus light therapy (SEC + L) and sleep education classes plus parent sleep education plus light therapy (SEC + P + L). We expect that compared to the control classes that improvements in sleep and mood will occur in all 3 versions of the sleep education classes. We expect that the SEC + P + L will show the greatest improvements.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42514 0
A/Prof Michael Gradisar
Address 42514 0
Flinders University
School of Psychology
GPO Box 2100
Adelaide, SA, 5001
Country 42514 0
Australia
Phone 42514 0
+61 8 82012192
Fax 42514 0
Email 42514 0
[email protected]
Contact person for public queries
Name 42515 0
Michael Gradisar
Address 42515 0
Flinders University
School of Psychology
GPO Box 2100
Adelaide, SA, 5001
Country 42515 0
Australia
Phone 42515 0
+61 8 82012192
Fax 42515 0
Email 42515 0
[email protected]
Contact person for scientific queries
Name 42516 0
Michael Gradisar
Address 42516 0
Flinders University
School of Psychology
GPO Box 2100
Adelaide, SA, 5001
Country 42516 0
Australia
Phone 42516 0
+61 8 82012192
Fax 42516 0
Email 42516 0
[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.