Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000360910
Ethics application status
Approved
Date submitted
20/02/2020
Date registered
13/03/2020
Date last updated
1/11/2022
Date data sharing statement initially provided
13/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Sleep Transitions and Regularity Study (STARs): A longitudinal study of the developmental significance of children’s sleep transition in early childhood
Scientific title
A prospective longitudinal study of diurnal sleep patterns in children aged 1-5 years and their association with development, learning and health outcomes.
Secondary ID [1] 295250 0
Nil known
Universal Trial Number (UTN)
U1111-1248-5635
Trial acronym
STARs
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Sleep Health 316360 0
Condition category
Condition code
Public Health 314622 314622 0 0
Health promotion/education
Public Health 314623 314623 0 0
Other public health
Mental Health 314624 314624 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A prospective, longitudinal study of N=300 children aged 12 months (base-line) to age 5 years (school entry). Objective measurements of sleep patterns will be collected for two-weeks using a watch-like activity monitor (actigraphy), once every 6 months, across 8 data collection time points (i.e. approximately until children reach school entry). Exposure will be naturalistic, with children recruited from across community samples and observed as they undertake their daily activities (e.g. in the home, childcare settings and outside the home).

Children’s participation will also include participating in iPad activities. Parent’s participation will involve answering surveys and installing a light and temperature sensor in their home. Surveys will include questions about children and their family including their experiences, their child’s height and weight, development and sleep.
Intervention code [1] 316918 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322952 0
Primary Outcome 1 – 24-hour sleep pattern as assessed with objective ambulatory measure (actigraphy) for 2 week period.
Timepoint [1] 322952 0
Time point 1 – Baseline and every 6 months for a total of 8 time point (i.e. approximately until school entry).
Primary outcome [2] 322953 0
Primary Outcome 2 – Children’s development assessed via the Ages and Stages Questionnaire (parent reported).
Timepoint [2] 322953 0
Time point 2 – Baseline and every 6 months for 4 years (i.e. total of 8 time points).
Primary outcome [3] 322954 0
Primary Outcome 3 – Environmental light exposure (Lux) assessed via ambulatory measure (actigraphy) continuously over 2-weeks and through environmental sensors in home (bedroom) and childcare environment (sleep-room).
Timepoint [3] 322954 0
Time point 3 – Actigraph - Baseline and every 6 months for 4 years (i.e. total of 8 time points); Childcare (sleep room) - once per year for 4 years. Home (bedroom) - Continuously for 4 years of the study.
Secondary outcome [1] 380352 0
Secondary Outcome 1 – Executive functioning assessed via the NIH toolkit for preschool aged children.
Timepoint [1] 380352 0
Time point 1 – Once per year in year 3 and 4 of the study (i.e. when children are aged 3 and 4 years of age)
Secondary outcome [2] 380353 0
BMI assessed through parental reports of height and weight.
Timepoint [2] 380353 0
Time point 2 – Baseline and every 6 months for 4 years (i.e. total of 8 time points).
Secondary outcome [3] 380354 0
Secondary Outcome 3 – Educator sleep practices in childcare settings via direct observation using the Sleep Observation Measure for ECEC (SOME)
Timepoint [3] 380354 0
Time point 3 – Once per year for 4 years.
Secondary outcome [4] 380355 0
Secondary Outcomes 4 – Parent mental health (stress and anxiety) assessed via the Keissler-10 (K10)
Timepoint [4] 380355 0
Time point 4 - Baseline and every 6 months for 4 years (i.e. total of 8 time points).
Secondary outcome [5] 380356 0
Secondary Outcomes 5 – Children’s sleep problems assessed via the Tayside Sleep Problems Questionnaire
Timepoint [5] 380356 0
Time point 5 - Baseline and every 6 months for 4 years (i.e. total of 8 time points).

Eligibility
Key inclusion criteria
Inclusion criteria at the target regions will include all small local areas (SLAs) located in and surrounding Brisbane, Australia, with targeted recruitment in SLAs randomly selected based on the stratification frame. Inclusion criteria at the child level includes a child aged 9 to 12 months.
Minimum age
9 Months
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria at the child level includes significant medical, neurological, or developmental disorder, or out of home placement. Additionally, retention of families across the four years of the study is critical, therefore, families who do not wish, or perceive they will be unable, to participate in each wave of data collection, will be excluded from the study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Statistical analyses (will assess the relationship between different sleep patterns and a range of children’s outcomes for approximately 300 children. Data will be collected on each participant every six months over the four years of the study. Relationship with child, family and childcare characteristics will also be examined. Multivariate statistical models will be applied to model the course and interrelationship of different indicators of sleep transitions and childhood outcomes. Insight into the mechanisms of the pathways between individual characteristics, care environment, sleep trajectories and outcomes will be assessed using several modelling approaches including GBTM and mixed modelling, considering a range of mediation and moderation in the analyses. The proposed sample of 300 children provides power to detect ‘small’ effects for change in the primary outcome variables with alpha set at 0.05.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
20/04/2020
Actual
23/11/2020
Date of last participant enrolment
Anticipated
31/12/2021
Actual
21/09/2021
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
300
Accrual to date
Final
257
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 299839 0
Government body
Name [1] 299839 0
Australian Research Council (ARC) Grant
Country [1] 299839 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
The University of Queensland. St. Lucia, Brisbane, QLD 4072
Country
Australia
Secondary sponsor category [1] 299193 0
None
Name [1] 299193 0
Address [1] 299193 0
Country [1] 299193 0
Other collaborator category [1] 281209 0
Government body
Name [1] 281209 0
Australian Children’s Education and Care Quality Authority (ACECQA)
Address [1] 281209 0
175 Liverpool St, Sydney NSW 2000
Country [1] 281209 0
Australia
Other collaborator category [2] 281210 0
University
Name [2] 281210 0
The University of Bristol
Address [2] 281210 0
Senate House, Tyndall Ave, Bristol BS8 1TH
Country [2] 281210 0
United Kingdom
Other collaborator category [3] 281211 0
University
Name [3] 281211 0
The University of Colorado
Address [3] 281211 0
Boulder, CO 80309
Country [3] 281211 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300716 0
University of Queensland Human Research Ethics Committee B
Ethics committee address [1] 300716 0
Ethics committee country [1] 300716 0
Australia
Date submitted for ethics approval [1] 300716 0
11/10/2019
Approval date [1] 300716 0
21/01/2020
Ethics approval number [1] 300716 0
2019002486

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

Contacts
Principal investigator
Name 84586 0
Dr Sally Staton
Address 84586 0
Institute for Social Science Research,
The University of Queensland,
80 Meiers Rd, Indooroopilly QLD 4068
Country 84586 0
Australia
Phone 84586 0
+61 7 3346 7698
Fax 84586 0
Email 84586 0
s.staton@uq.edu.au
Contact person for public queries
Name 84587 0
Sally Staton
Address 84587 0
Institute for Social Science Research,
The University of Queensland,
80 Meiers Rd, Indooroopilly QLD 4068
Country 84587 0
Australia
Phone 84587 0
+61 7 3346 7698
Fax 84587 0
Email 84587 0
s.staton@uq.edu.au
Contact person for scientific queries
Name 84588 0
Sally Staton
Address 84588 0
Institute for Social Science Research,
The University of Queensland,
80 Meiers Rd, Indooroopilly QLD 4068
Country 84588 0
Australia
Phone 84588 0
+61 7 3346 7698
Fax 84588 0
Email 84588 0
s.staton@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Start date: Immediately following publication
End date: No end date determined
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal and/or for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator (s.staton@uq.edu.au)


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.