Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000381280
Ethics application status
Approved
Date submitted
23/02/2018
Date registered
14/03/2018
Date last updated
25/02/2019
Date data sharing statement initially provided
25/02/2019
Date results information initially provided
25/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot RCT of a childcare-based educator professional development program to improve sleep health in preschool aged children
Scientific title
Pilot RCT of a childcare-based educator professional development program to improve sleep health in preschool aged children
Secondary ID [1] 294150 0
Nil known
Universal Trial Number (UTN)
U1111-1209-7868
Trial acronym
CRS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pediatric sleep problems 306776 0
Condition category
Condition code
Public Health 305871 305871 0 0
Health promotion/education
Mental Health 306099 306099 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Choosing Rest Program: targeted educator professional development program focuses on improving knowledge, process and delivery of sleep practices for children in childcare services. Topics covered include: evidence from research of current sleep practices in childcare services, information about normal sleep development in young children (including importance of sleep, sleep duration, timing, daytime napping patterns, circadian and homeostatic sleep drive, sleep antecedents and rest and relaxation in adults and children) and information on the expectations for sleep, rest and relaxation within the Australian childcare regulatory framework. Program delivery will be conducted by a trained facilitator with extensive expertise within the childcare sector. The program is personalized, and includes an initial consultation (30 minutes) with a service leader to identify key areas of concerns regarding children's sleep within their service. Following initial consultation a 2 hour face-to-face facilitated professional development workshop is conducted with service staff, with two week follow-up support via phone consultation (i.e. one phone call at the end of two weeks). Professional development workshops are conducted on-site at service location, or at the childcare service head office. For centre-based childcare services workshops are run as a group for all educators within the service. For home-based childcare services workshops are run as a group of all educators within a family day care scheme. During these workshops educators are taken through a slide presentation with the facilitator covering three areas: (1) research evidence on current sleep practices in childcare services, (2) information on normal sleep development in young children, (3) sleep, rest and relaxation and expectations for sleep, rest and relaxation within the Australian childcare regulatory framework. During these workshops educators also participate in 5 reflective practice activities focused on incorporating new knowledge from the workshops into their service and individual practices (including: identifying high quality sleep, rest and relaxation practices, reflecting on their current practices, reflecting on what rest and relaxation for children, reflecting on how new knowledge of sleep, rest and relaxation for children can inform their practice). Throughout the 2-month intervention and implementation phase, data to support process evaluation, including field notes, artefacts and participation reports will be collected.
Intervention code [1] 300437 0
Behaviour
Intervention code [2] 300600 0
Treatment: Other
Comparator / control treatment
Active Waitlist control: Services allocated to the control condition will undertake “treatment as usual” (i.e. they will implement their normal sleep, rest and relaxation practices within their service). Control services will participate in the professional development program between 2-4 weeks following final data collection.
Control group
Active

Outcomes
Primary outcome [1] 304913 0
Regularity of sleep onset times as assessed by 24 hour actigraphy.
Timepoint [1] 304913 0
Baseline and 6 weeks after intervention completion
Primary outcome [2] 304914 0
Severity of disorders of initiating and maintaining sleep (DIMS) via the Tayside Sleep Problems Questionnaire.
Timepoint [2] 304914 0
Baseline and 6 weeks after intervention completion
Primary outcome [3] 305131 0
Prevalence of disorders of initiating and maintaining sleep (DIMS) via the Tayside Sleep Problems Questionnaire.
Timepoint [3] 305131 0
Baseline and 6 weeks after intervention commencement
Secondary outcome [1] 343608 0
Educator Sleep Practices in Childcare setting via direct observation using the Sleep Observation Measure for ECEC (SOME).
Timepoint [1] 343608 0
Baseline and 6 weeks after intervention completion
Secondary outcome [2] 343609 0
Child behavioral response to naptimes in Childcare setting via the Individualised Classroom Assessment Scoring System (inCLASS).
Timepoint [2] 343609 0
Baseline and 6 weeks after intervention completion

Eligibility
Key inclusion criteria
Inclusion criteria for childcare settings includes Long Day Care services with a current mandatory naptime and no prior participation in the Choosing Rest Program. Inclusion criteria for children includes the absence of significant medical, neurological, or developmental disorder, and no out-of-home placement.
Minimum age
1 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For service: No current mandatory naptime and/or prior participation in the Choosing Rest program. For children: significant medical, neurological, or developmental disorder, or out of home placement.

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)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Estimates of the effects of the program intervention on children’s sleep problems will be assessed via a 2 (intervention/control) x 2 (pre/post) repeated measures analysis of variance (ANOVA). For ANOVA with repeated measures, the proposed sample size of 150 children (75 per arm) provides >80% power to detect 'small' effects (f~0.1) for change in the primary outcome variables with alpha set at 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/03/2018
Actual
22/03/2018
Date of last participant enrolment
Anticipated
31/05/2018
Actual
1/06/2018
Date of last data collection
Anticipated
12/07/2018
Actual
24/08/2018
Sample size
Target
150
Accrual to date
Final
109
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 298787 0
Government body
Name [1] 298787 0
Queensland Government Department of Education
Country [1] 298787 0
Australia
Funding source category [2] 298788 0
Charities/Societies/Foundations
Name [2] 298788 0
Thrasher Research Fund
Country [2] 298788 0
United States of America
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] 297968 0
None
Name [1] 297968 0
Address [1] 297968 0
Country [1] 297968 0
Other collaborator category [1] 279959 0
Commercial sector/Industry
Name [1] 279959 0
Crèche and Kindergarten Association
Address [1] 279959 0
257 Gympie Road, Kedron QLD 4031
Country [1] 279959 0
Australia
Other collaborator category [2] 279960 0
Commercial sector/Industry
Name [2] 279960 0
Family Day Care Queensland
Address [2] 279960 0
7/20 Smallwood Place Murarrie Qld 4172
Country [2] 279960 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299733 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 299733 0
The University of Queensland
St Lucia
Brisbane QLD 4072 Australia
Ethics committee country [1] 299733 0
Australia
Date submitted for ethics approval [1] 299733 0
10/10/2017
Approval date [1] 299733 0
16/01/2018
Ethics approval number [1] 299733 0
2017001866

Summary
Brief summary
Sleep problems are estimated to effect between 20-30% of children internationally, with immediate and longer-term impacts on physical health, learning, behavior and family functioning. Current evidence identifies early childhood as a critical period for intervention strategies to avert sleep problems and establish positive lifetime health trajectories. Childcare is an integral part of most children’s early life experience, and provides a point for promotion of sleep health and early interventions for sleep problems. The benefit of early intervention in childcare to improve sleep health and address specific sleep problems has not been tested. The aims of this study are to establishing the fidelity of conducting a gold standard RCT of an educator focused professional development sleep intervention program (Choosing Rest) in childcare settings and estimate the effects of an educator focused professional development program (Choosing Rest) in reducing the severity and/or incidence of sleep problems in young childhood. We hypothesis that children in the intervention group will demonstrate a larger mean reduction in the severity and/or incidence of objectively measured sleep problems from pre- to post- intervention when compared to those in the control (treatment as usual) group. This study will integrate objective measurement of sleep patterns and sleep problems via actigraphy to a concurrent randomized control pilot trial testing the fidelity of a of a professional development program aimed at improving sleep practices in childcare settings. Pre- and post- intervention actigraphy (N=150 children aged 1-5 years) will be used to measure 24-hr sleep-wake patterns continuously across a 1-week period. If successful, this trial will lead to the application of a gold standard RCT study to provide evidence to support implementation into Australian childcare practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81398 0
Dr Sally Staton
Address 81398 0
The University of Queensland, Institute for Social Science Research, 80 Meiers Rd, Indooroopilly QLD 4068 Australia
Country 81398 0
Australia
Phone 81398 0
+61 7 3346 7698
Fax 81398 0
Email 81398 0
[email protected]
Contact person for public queries
Name 81399 0
Dr Sally Staton
Address 81399 0
The University of Queensland, Institute for Social Science Research, 80 Meiers Rd, Indooroopilly QLD 4068 Australia
Country 81399 0
Australia
Phone 81399 0
+61 7 3346 7698
Fax 81399 0
Email 81399 0
[email protected]
Contact person for scientific queries
Name 81400 0
Dr Sally Staton
Address 81400 0
The University of Queensland, Institute for Social Science Research, 80 Meiers Rd, Indooroopilly QLD 4068 Australia
Country 81400 0
Australia
Phone 81400 0
+61 7 3346 7698
Fax 81400 0
Email 81400 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Other filesNo Queensland Education Research Inventory
Conference abstractNo 1. Staton, S., Smith, S., Irvine, S., Pattinson, C... [More Details]

Documents added automatically
No additional documents have been identified.