Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000649819
Ethics application status
Approved
Date submitted
17/06/2012
Date registered
19/06/2012
Date last updated
19/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sleep hygiene intervention to aid sleep problems in youth
Scientific title
Sleep hygiene intervention for problematic sleep in youth aged 10 to 18 years: a before-after pilot study of sleep and weight
Secondary ID [1] 280672 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
problematic sleep 286694 0
Condition category
Condition code
Public Health 286992 286992 0 0
Health promotion/education
Other 287013 287013 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants recruited in the study will receive the sleep hygiene education programme. The programme consists of a one-time sleep hygiene education intervention, a sleep education ‘kit’ as well as ongoing support via telephone calls, text messages and get-together sessions. The initial intervention focuses on good sleep hygiene education via a multi-media presentation. The intervention lasts about 90 minutes and is delivered, in a private one-one session to the participant and one of their parents by the main researcher within a power point presentation with discussion centred on overcoming individual barriers to adherence. The sleep hygiene intervention instructions target three main areas of sleep: 1) nutrition conducive to good sleep; 2) sleep environment and 3) sleep routine. The programme is packaged as the F.E.R.R.E.T sleep hygiene programme; an acronym for Food, Emotions, Routine, Restrict, Environment and Timing, with each category consisting of three easy to remember sleep rules pertaining to their respective categories. The participants take home an individualised F.E.R.R.E.T flip-book containing the acronyms and rules in an easy reference format, and space to write notes down should they wish to. The F.E.R.R.E.T flip-book also had a compact disc (CD) containing the F.E.R.R.E.T multi-media presentation. Post-intervention support includes fortnightly telephone calls to the participant, a dedicated F.E.R.R.E.T cell phone number which participants could call or text any time with sleep issues, as well as one-one informal session (approximately 30 to 45 minutes) every at 6, 12 and 18 weeks post-intervention with the researcher to discuss progress and provide an opportunity for data collection.
Outcomes are assessed at 6, 12, and 20 weeks post-intervention to follow changes over time.
Intervention code [1] 285078 0
Treatment: Other
Intervention code [2] 285095 0
Lifestyle
Intervention code [3] 285096 0
Behaviour
Comparator / control treatment
Same treatment is applied all the group in a before-after comparison
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287344 0
Adolescent Sleep Hygiene scale: The ASHS is a 28-item self-report questionnaire that assesses sleep-facilitating and sleep-inhibiting practices in adolescents along nine different domains: physiological, cognitive, emotional, sleep environment, daytime sleep, substances, bedtime routine, sleep stability, and bed/bedroom sharing. The ASHS shows concurrent validity associations with the Adolescent Sleep Wake Scale (ASWS)
Timepoint [1] 287344 0
The ASHS will be administered on 5 occasions: 1 and 2 weeks before the intervention and 6, 12 and 20 weeks post-intervention.
Primary outcome [2] 287345 0
Pittsburgh Sleep Quality Index (PSQI): a 19-item self-report questionnaire which measures sleep quality during the previous month to discriminate between good and poor sleepers. The PSQI generates seven domain scores with each domain score ranging from zero to three. The domain scores are summed to produce a global score ranging from zero to 21, where a PSQI global score of greater than five is considered to be suggestive of significant sleep disturbance. The PSQI has good reliability with high internal consistency (Chronbach's alpha = 0.83) as well as test-retest reliability
Timepoint [2] 287345 0
The PSQI will be administered on 5 occasions: 1 and 2 weeks before the intervention and 6, 12 and 20 weeks post-intervention.
Primary outcome [3] 287346 0
Sleep Disturbances Scale for Children (SDSC): a 26-item parent-report questionnaire which measures sleep quality and disturbance in children and adolescents. The SDSC has high internal consistency (alpha = 0.79), test/retest reliability (r = 0.71)
Timepoint [3] 287346 0
The SDSC will be administered on 5 occasions: 1 and 2 weeks before the intervention and 6, 12 and 20 weeks post-intervention.
Secondary outcome [1] 297954 0
Anthropometry: Height and weight measurements will be measured within a clinic setting and BMI and BMI z-scores calculated. Height, to the nearest 0.1 cm, wil be measured using a wall-mounted stadiometer and weight, to the nearest 0.1 kg, was measured with shoes, jackets, sweatshirts and hats removed. Waist circumference (WC) will be measured, to the nearest 0.1 cm, at the level of the iliac crest just below the navel.
Timepoint [1] 297954 0
2 weeks before and 20 weeks post-intervention
Secondary outcome [2] 297955 0
Attention and vigilance: The Conners Continuous Performance Test II (CPT-II) will be used: an electronic attention and vigilance test used to assess sustained attention, and is often used in studies of Attention-Deficit/Hyperactivity Disorder (ADHD).
Timepoint [2] 297955 0
2 weeks before and 20 weeks post-intervention
Secondary outcome [3] 297956 0
Energy Expenditure (EE): EE measured over a seven day/24 h period using an Actical accelerometer (Mini-Mitter, Respironics, USA). The Actical accelerometer is a small, water resistant motion sensor capable of sensing and recording omnidirectional acceleration and activity ranging from sedentary to vigorous movements.
Timepoint [3] 297956 0
2 weeks before and 20 weeks post-intervention

Eligibility
Key inclusion criteria
Developmentally healthy children with self-identified sleep problems such as difficulties falling asleep, or staying asleep.
Minimum age
10 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current diagnosis of a primary sleep disorder or any uncontrolled medical conditions.
Living outside the greater Dunedin area.
Currently taking medication for insomnia or taking medication for insomnia throughout the period of enrolment.
Participants with inadequate English language fluency.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Any individuals who read or hear about the study from the community via newspaper advertisements, posters (placed in supermarkets and the local hospital), letters to schools, and by word of mouth can participate if they meet the inclusion/exclusion criteria. They contact the researchers and eligibility assessed over the phone and again at the first face-face appointment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
33
Accrual to date
Final
Recruitment outside Australia
Country [1] 4364 0
New Zealand
State/province [1] 4364 0

Funding & Sponsors
Funding source category [1] 285451 0
University
Name [1] 285451 0
University of Otago
Country [1] 285451 0
New Zealand
Primary sponsor type
Individual
Name
Dr Barbara Galland
Address
Department of Women's & Children's Health
PO Box 913
Dunedin 9018
Country
New Zealand
Secondary sponsor category [1] 284305 0
University
Name [1] 284305 0
University of Otago
Address [1] 284305 0
PO Box 56
Dunedin 9018
Country [1] 284305 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287463 0
Lower South Regional Ethics Committee
Ethics committee address [1] 287463 0
Ethics committee country [1] 287463 0
New Zealand
Date submitted for ethics approval [1] 287463 0
Approval date [1] 287463 0
18/02/2008
Ethics approval number [1] 287463 0
LRS/07/12/055

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

Contacts
Principal investigator
Name 34312 0
Address 34312 0
Country 34312 0
Phone 34312 0
Fax 34312 0
Email 34312 0
Contact person for public queries
Name 17559 0
Dr Barbara Galland
Address 17559 0
Department of Women's & Children's Health
PO Box 913
Dunedin 9018
Country 17559 0
New Zealand
Phone 17559 0
+ 64 3 4740999
Fax 17559 0
+ 64 3 4747817
Email 17559 0
[email protected]
Contact person for scientific queries
Name 8487 0
Dr Barbara Galland
Address 8487 0
Department of Women's & Children's Health
PO Box 913
Dunedin 9018
Country 8487 0
New Zealand
Phone 8487 0
+ 64 3 4740999
Fax 8487 0
Email 8487 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.