Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001056280
Ethics application status
Approved
Date submitted
21/06/2018
Date registered
25/06/2018
Date last updated
26/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sleep health in early childhood: What role does childcare play? (Sleep in the Early Years Study)
Scientific title
Understanding the role of sleep practices in early childhood education and care in supporting children's sleep health and development
Secondary ID [1] 295251 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep quality 308418 0
Condition category
Condition code
Public Health 307407 307407 0 0
Health promotion/education

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Within childcare services direct observations of sleep practices and sleep policies are conducted in rooms catering for infant [0-18 months] and toddler [18-36 months] aged children (n=40 rooms) via a standard intensive in-situ observation measure: The Sleep Observation Measure for Early Childhood Education and Care (SOME; Staton et al, 2015). The SOME is a multi-item observational tool used to collect detailed records of sleep environments, sleep practices and children’s behavioural responses within childcare settings. Observations are conducted on a single day in each childcare settings, commencing at approximately 9am and ending at approximately 2:30 pm). Educators within each service also complete a brief survey regarding current sleep policies, including parent-educator communication strategies. Outcomes data is collected at two time-points (baseline and 6 months following initial observation).
Intervention code [1] 301585 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306380 0
Child sleep/wake patterns measured continuously over a 2-week period using actigraphy alongside parent reported sleep diaries.
Timepoint [1] 306380 0
Collected for infants and toddlers aged 12-36 months at two time points, at baseline and 6-month follow-up.
Primary outcome [2] 306381 0
Children’s body mass index (BMI) z-scores recorded by the research staff using balance scales and stadiometer applying standard WHO protocols.
Timepoint [2] 306381 0
Collected for infants and toddlers aged 0-36 months at two time points, at baseline and 6-month follow-up.
Primary outcome [3] 306382 0
Parent reported sleep problems using the Tayside Children's Sleep Questionnaire
Timepoint [3] 306382 0
Collected for infants and toddlers aged 0-36 months at two time points, at baseline and 6-month follow-up.
Secondary outcome [1] 348294 0
Parent report of child behavior via the Strengths and Difficulties Questionnaire
Timepoint [1] 348294 0
Collected for infants and toddlers aged 0-36 months at two time points, at baseline and 6-month follow-up.
Secondary outcome [2] 348295 0
Parent mental health via the K10 Parental Stress Scale
Timepoint [2] 348295 0
Collected for parents of infants and toddlers aged 0-36 months at two time points, at baseline and 6-month follow-up.
Secondary outcome [3] 348296 0
Child Sleep Behaviors via the Brief Infant Sleep Questionaire
Timepoint [3] 348296 0
Collected for parents of infants and toddlers aged 0-36 months at two time points, at baseline and 6-month follow-up.

Eligibility
Key inclusion criteria
Direct observations of sleep practices are conducted across 40 childcare rooms (one each of infant [0-18 months] and toddler [18-36 months]), sited within 20 long day care childcare services and 6 family day care rooms. To capture a range of social and developmental profiles, services are randomly selected from within stratification of small local areas identified by the AEDC as of high, moderate and low vulnerability. All families with children aged 0-36 months attending target childcare rooms are eligible to participate.
Minimum age
No limit
Maximum age
36 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Criteria for exclusion includes significant medical, neurological, or developmental disorder, or out of home placement.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Since this is a highly innovative exploratory study with no precedence in the literature, there are no previous data on which a credible sample size calculation can be based. Thus, as explained in Bacchetti et al. it would be inappropriate to conduct such as sample size calculation. Rather, the proposed sample size is based on our experience with related outcomes. The anticipated sample is approximately 200 children, based on a conservative mean uptake of 5 children per room, consistent with our prior studies recruited in this way.

Descriptive analyses will be conducted to examine sleep practices and child sleep patterns. Regression analyses will be conducted to examine the relationship between childcare sleep practice and children’s sleep patterns and behaviours. Analyses will model concurrent and follow-up outcomes and consider both the independent effects of childcare practice and concordance of home and childcare sleep practices on children’s sleep health. Child, family and service characteristics will also be measured and included as controls.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/06/2016
Date of last participant enrolment
Anticipated
Actual
5/06/2017
Date of last data collection
Anticipated
Actual
5/10/2017
Sample size
Target
200
Accrual to date
Final
207
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 299840 0
Government body
Name [1] 299840 0
Queensland Government, Department of Education
Country [1] 299840 0
Australia
Funding source category [2] 299841 0
Government body
Name [2] 299841 0
The National Health and Medical Research Council
Country [2] 299841 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St Lucia
Brisbane QLD 4072 Australia
Country
Australia
Secondary sponsor category [1] 299194 0
University
Name [1] 299194 0
Queensland University of Technology
Address [1] 299194 0
2 George St, Brisbane City QLD 4000, Australia
Country [1] 299194 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300739 0
'Queensland University of Technology University Human Research Ethics Committee [EC00171]
Ethics committee address [1] 300739 0
Ethics committee country [1] 300739 0
Australia
Date submitted for ethics approval [1] 300739 0
Approval date [1] 300739 0
20/06/2016
Ethics approval number [1] 300739 0

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

Contacts
Principal investigator
Name 84590 0
Dr Sally Staton
Address 84590 0
The University of Queensland Long Pocket Precinct
80 Meiers Rd
Room 217-2
Building D (Dianella 1021)
Indooroopilly QLD 4068
Country 84590 0
Australia
Phone 84590 0
+61 7 3346 7698
Fax 84590 0
Email 84590 0
[email protected]
Contact person for public queries
Name 84591 0
Sally Staton
Address 84591 0
The University of Queensland Long Pocket Precinct
80 Meiers Rd
Room 217-2
Building D (Dianella 1021)
Indooroopilly QLD 4068
Country 84591 0
Australia
Phone 84591 0
+61 7 3346 7698
Fax 84591 0
Email 84591 0
[email protected]
Contact person for scientific queries
Name 84592 0
Sally Staton
Address 84592 0
The University of Queensand Long Pocket Precinct
80 Meiers Rd
Room 217-2
Building D (Dianella 1021)
Indooroopilly QLD 4068
Country 84592 0
Australia
Phone 84592 0
+61 7 3346 7698
Fax 84592 0
Email 84592 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
SourceTitleYear of PublicationDOI
EmbaseObserved compliance with safe sleeping guidelines in licensed childcare services.2019https://dx.doi.org/10.1136/archdischild-2019-317000
N.B. These documents automatically identified may not have been verified by the study sponsor.