ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sleep quality

Condition category

Condition code

Public Health

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Child sleep/wake patterns measured continuously over a 2-week period using actigraphy alongside parent reported sleep diaries.

Timepoint [1]

Collected for infants and toddlers aged 12-36 months at two time points, at baseline and 6-month follow-up.

Primary outcome [2]

Children’s body mass index (BMI) z-scores recorded by the research staff using balance scales and stadiometer applying standard WHO protocols.

Timepoint [2]

Collected for infants and toddlers aged 0-36 months at two time points, at baseline and 6-month follow-up.

Primary outcome [3]

Parent reported sleep problems using the Tayside Children's Sleep Questionnaire

Timepoint [3]

Collected for infants and toddlers aged 0-36 months at two time points, at baseline and 6-month follow-up.

Secondary outcome [1]

Parent report of child behavior via the Strengths and Difficulties Questionnaire

Timepoint [1]

Collected for infants and toddlers aged 0-36 months at two time points, at baseline and 6-month follow-up.

Secondary outcome [2]

Parent mental health via the K10 Parental Stress Scale

Timepoint [2]

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]

Child Sleep Behaviors via the Brief Infant Sleep Questionaire

Timepoint [3]

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]

Government body

Name [1]

Queensland Government, Department of Education

Address [1]

42-60 Albert Street, Brisbane, Qld 4000

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

The National Health and Medical Research Council

Address [2]

16 Marcus Clarke St
Canberra ACT 2601

Country [2]

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]

University

Name [1]

Queensland University of Technology

Address [1]

2 George St, Brisbane City QLD 4000, Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

'Queensland University of Technology University Human Research Ethics Committee [EC00171]

Ethics committee address [1]

2 George St, Brisbane City QLD 4000, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

20/06/2016

Ethics approval number [1]

Summary

Brief summary

The early years of life are critical in development of sleep behaviours and present the optimal window for promotion of healthy sleep patterns and early intervention to prevent and treat sleep problems. During this period, childcare plays a significant role in the lives of children and has demonstrated impacts on lifetime trajectories of health and development. This project focuses on the role of childcare in supporting sleep health of children aged 0-3 years.
The majority of Australian children attend childcare and many spend considerable hours in
childcare from early life, when sleep patterns are developing. Despite this, little is currently
known about impacts of childcare practices on young children’s sleep health. Yet prior to age 3, there are substantial challenges in this context that result from greater variability in child sleep need (including timing, duration and number of sleep periods), settling behaviours, and the complexity of parent demands. This study aims to examine current sleep practices for infants and toddlers (aged 0-36 months) in childcare settings. The focus is on addressing two key questions in establishing the role that childcare plays in younger children’s sleep health:
(1) Do childcare environments influence children’s sleep patterns and behaviours?
(2) Does consistency between sleep practices in childcare and at home influence the regularity of children’s sleep patterns?

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Sally Staton

Address

The University of Queensland Long Pocket Precinct
80 Meiers Rd
Room 217-2
Building D (Dianella 1021)
Indooroopilly QLD 4068

Country

Australia

Phone

+61 7 3346 7698

Fax

s.staton@uq.edu.au

Contact person for public queries

Name

Sally Staton

Address

The University of Queensland Long Pocket Precinct
80 Meiers Rd
Room 217-2
Building D (Dianella 1021)
Indooroopilly QLD 4068

Country

Australia

Phone

+61 7 3346 7698

Fax

s.staton@uq.edu.au

Contact person for scientific queries

Name

Sally Staton

Address

The University of Queensand Long Pocket Precinct
80 Meiers Rd
Room 217-2
Building D (Dianella 1021)
Indooroopilly QLD 4068

Country

Australia

Phone

+61 7 3346 7698

Fax

s.staton@uq.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Observed compliance with safe sleeping guidelines in licensed childcare services.	2019	https://dx.doi.org/10.1136/archdischild-2019-317000

N.B. These documents automatically identified may not have been verified by the study sponsor.

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