Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001568303
Ethics application status
Approved
Date submitted
7/11/2017
Date registered
21/11/2017
Date last updated
19/11/2019
Date data sharing statement initially provided
19/11/2019
Date results information initially provided
19/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Preschool Situational Self-Regulation Toolkit (PRSIST) Program for Supporting Children’s Early Self-Regulation Development
Scientific title
Evaluation of the Preschool Situational Self-Regulation Toolkit (PRSIST) Program for Supporting Children’s Early Self-Regulation Development: Study protocol for a cluster randomized controlled trial
Secondary ID [1] 293307 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PRSIST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early child development 305388 0
Self-regulation 305389 0
Condition category
Condition code
Mental Health 304675 304675 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Preschool Situational Self-Regulation Toolkit (PRSIST) Program is a collection of low-cost adult practices and child activities, to be implemented primarily by pre-school educators, that are compatible with early childhood education and care contexts, routines and practices. The program is flexible in its duration, but for this trial will be implemented by educators over the course of 6 months.

The program consists of four core elements:
1. Adult practices. Educators will be given a practice manual that describes nine principles that are believed to be supportive of self-regulation development. Each practice is described on a single page, providing a description of the principle (e.g., engage children in problem solving), a real-life case to illustrate its importance (e.g., a child reticent to engage in an activity for fear of being incorrect), and specific practices related to the principle (e.g., open-ended questions). These principles and practices are further supported by a series of nine online PD videos (on our www.prsist.com.au website) that educators will view within the first two months of the program.

2. Child activities. A collection of 28 game- and play-like activities have also been developed, based on: observations of practices at high quality pre-school services; minimal modification of existing practices in high quality centres (modified to maximise self-regulatory benefit); or newly created, but piloted by educators across a range of pre-school services. The activities are each described on our www.prsist.com.au website, and are also compiled into a series of children's book as a soft entry into educators reading about and conducting the activities (i.e., each children's story has activities linked to central plot points, and then compiles all activities in an appendix at the end of the book). Educators will be asked to complete at least three of the activities, of their choosing, each week during the intervention period.

3. Parent newsletters. While the program is not specifically being given to parents to enact in this study, monthly parent newsletters over the course of the intervention period will help to inform parents about their child's activities, about self-regulation and its importance, and give suggestions for how parents can additionally support the efforts on their child's pre-school at home. Each newsletter is one double-sided page.

4. Formative assessment of self-regulation. Lastly, pre-school educators will be given our new PRSIST formative assessment tool, which is an observational measure of self-regulation that helps to structure educators' observations toward key areas of self-regulation, and provides actionable data about a child's developmental progress. Educators' use of this tool will help the educators to tailor the complexity of the child activities to a child's current development. The tool, training in its use and reliability checks are all provided in our www.prsist.com.au website.

Adherence/Fidelity: While the specific selection and sequence of activities will not be dictated (so that the intervention is flexible), we will collect information on which, when and how many times each activity is completed using a wall calendar sticker chart that is collected each month (also as a fidelity check). These will be self-reported by educators in the centres. Parent newsletters will also be sent to centres each month, along with a brief check-in phone call to centres, as a stimulus to continue and as a means to answer any questions that arise.

The program has been designed to be flexible (in response to the needs and demands of the educators working within the sector), low-cost (so that practices and activities can be done in a range of contexts and socio-economic conditions) and so that, if successful, it can be freely and widely disseminated (anyone can access our www.prsist.com.au website at no cost to be able to access the program in part or in full).
Intervention code [1] 299566 0
Behaviour
Comparator / control treatment
The study employs a clustered randomised controlled trial design. Fifty pre-school centres will be selected and then, after baseline data collection, stratified to intervention and control groups according to pre-existing NQS ratings (i.e., working towards, meeting or exceeding national standards). Control centres will continue their usual early learning activities.
Control group
Active

Outcomes
Primary outcome [1] 303890 0
The primary outcome is children's self-regulation, as indexed by performance on the Head-Toes-Knees-Shoulders (HTKS) task, which is an objective measure of self-regulation that takes about 8 minutes to complete (McClelland, 2014).
Timepoint [1] 303890 0
Baseline and 7 months later, at the end of the intervention.
Primary outcome [2] 303891 0
The other primary outcome is children's self-regulation, as indexed by performance on the Preschool Situational Self-Regulation Toolkit (PRSIST) formative assessment, which is a new observational measure of self-regulation that takes about 15 minutes to complete (Howard et al., forthcoming).
Timepoint [2] 303891 0
Baseline and 7 months later, at the end of the intervention
Secondary outcome [1] 340365 0
One secondary outcome is children's self-regulation, as indexed by parent- and educator-report on the Child Behaviour Rating Scale (CBRS), which is an adult-report questionnaire measure of self-regulation that takes about 5 minutes to complete (Bronson et al., 1990).
Timepoint [1] 340365 0
Baseline and 7 months later, at the end of the intervention
Secondary outcome [2] 340366 0
Another secondary outcome is children's self-regulation, as indexed by parent- and educator-report on the Child Self-Regulation & Behaviour Questionnaire (CSBQ), which is an adult-report questionnaire measure of self-regulation that takes about 5 minutes to complete (Howard & Melhuish, 2017).
Timepoint [2] 340366 0
Baseline and 7 months later, at the end of the intervention
Secondary outcome [3] 340367 0
Another secondary outcome is children's executive function (working memory), as indexed by the Early Years Toolbox's Mr Ant task, which is direct assessment that takes about 8 minutes to complete (Howard & Melhuish, 2017).
Timepoint [3] 340367 0
Baseline and 7 months later, at the end of the intervention
Secondary outcome [4] 340368 0
Another secondary outcome is children's executive function (inhibition), as indexed by the Early Years Toolbox's Go/No-Go task, which is direct assessment that takes about 5 minutes to complete (Howard & Melhuish, 2017).
Timepoint [4] 340368 0
Baseline and 7 months later, at the end of the intervention
Secondary outcome [5] 340369 0
Another secondary outcome is children's executive function (shifting), as indexed by the Early Years Toolbox's Card Sort task, which is direct assessment that takes about 8 minutes to complete (Howard & Melhuish, 2017).
Timepoint [5] 340369 0
Baseline and 7 months later, at the end of the intervention
Secondary outcome [6] 340370 0
Another secondary outcome is children's school readiness, as indexed by the Bracken School Readiness Assessment, which is direct assessment that takes about 15 minutes to complete (Bracken, 2007).
Timepoint [6] 340370 0
Baseline and 7 months later, at the end of the intervention
Secondary outcome [7] 340464 0
At the educator level, a primary outcome is educators' self-rated knowledge, attitudes and self-efficacy (KASE) related to self-regulation, as captured on the Self-Regulation KASE survey (Vasseleu et al., forthcoming). This survey takes about 15 minutes to complete.
Timepoint [7] 340464 0
Baseline and 7 months later, at the end of the intervention

Eligibility
Key inclusion criteria
Fifty pre-school centres will be recruited to ensure a broad range of centre characteristics are represented, namely: National Quality Standards ratings (i.e., working towards, meeting, exceeding), geographic location (metropolitan and regional), and socio-economic areas (Deciles 1-8, according to SEIFA Advantage and Disadvantage indices). The sample has been selected to ensure representation across these variables, but it will not be fully representative of the population. Participating centres must also not be participating in other research for the duration of the evaluation year.
Minimum age
3 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Centres will be excluded if they are located out of state or do not have data on these stratification variables.

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)
As this study adopts a cluster randomised controlled trial design, participants (children and centres) will be assigned to control or intervention groups randomly by cluster (centre). This randomisation will not occur until after: (a) recruitment of centres is complete; and (b) the initial baseline data collection is complete. As such, those involved in recruitment of centres will be unaware, at the time of recruitment, to which group the centres will be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation of centres (cluster) using a randomisation table created by computer software (i.e. computerised sequence generation). The stratification variable is NQS rating, to ensure a balance across pre-school quality levels.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Firstly changes in child outcomes will be measured in a multi-level model where a specific intervention-control comparison will be included. Based on an ICC of .12 and a small effect size, 500 participants will be sufficient to detect a child-level effect at 80% power, an alpha of .05 and 10% attrition. For educator-level data, based on an ICC of .05 and a moderate effect size, 100 participants (at least two educators per centre) will be sufficient to detect this effect at 80% power and an alpha of .05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/01/2018
Actual
22/01/2018
Date of last participant enrolment
Anticipated
Actual
28/02/2018
Date of last data collection
Anticipated
Actual
30/11/2018
Sample size
Target
600
Accrual to date
Final
473
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297932 0
Government body
Name [1] 297932 0
Australian Research Council
Country [1] 297932 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Early Start
University of Wollongong
Northfields Avenue
Wollongong, NSW
2522
Country
Australia
Secondary sponsor category [1] 296994 0
None
Name [1] 296994 0
Address [1] 296994 0
Country [1] 296994 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298978 0
University of Wollongong Social Sciences HREC
Ethics committee address [1] 298978 0
University of Wollongong
Northfields Avenue
Wollongong, NSW
2522
Ethics committee country [1] 298978 0
Australia
Date submitted for ethics approval [1] 298978 0
19/09/2017
Approval date [1] 298978 0
07/11/2017
Ethics approval number [1] 298978 0
HE2017/451

Summary
Brief summary
Using Community-Based Participatory Research (CBPR) methods, the completed first Phase of the Early Start to Self-Regulation project engaged key stakeholders in formative research (Phase 1; HE2017/029) to inform the design and piloting of a self-regulation intervention (Phase 2; HE2017/347). This next phase involves implementation and evaluation of our self-regulation program (Phase 3). Phase 3 will involve recruiting 50 pre-school centres, half of which will implement the PRSIST self-regulation program while the other half continues with normal practice. Data on children’s self-regulation, as well as related abilities, will be collected from participating children before and after implementation of the program to evaluate its impact. Data will also be collected from participating educators regarding their perceived self-regulatory knowledge, attitudes and self-efficacy related to self-regulation, both before and after the program, to evaluate change.
Trial website
http://www.prsist.com.au
Note: This website is currently in development, but will be available for the trial beginning in 2018.
Trial related presentations / publications
Howard, S. J., Vasseleu, E., Neilsen-Hewett, C., & Cliff, K. (2018). Evaluation of the Preschool Situational Self-Regulation Toolkit (PRSIST) Program for Supporting Children's Early Self-Regulation Development: Study protocol for a cluster randomized controlled trial. Trials, 19, 64. doi: 10.1186/s13063-018-2455-4.
Public notes

Contacts
Principal investigator
Name 78870 0
Dr Steven Howard
Address 78870 0
Early Start
University of Wollongong
Northfields Avenue
Wollongong, NSW
2522
Country 78870 0
Australia
Phone 78870 0
+61242215165
Fax 78870 0
Email 78870 0
[email protected]
Contact person for public queries
Name 78871 0
Dr Steven Howard
Address 78871 0
Early Start
University of Wollongong
Northfields Avenue
Wollongong, NSW
2522
Country 78871 0
Australia
Phone 78871 0
+61242215165
Fax 78871 0
Email 78871 0
[email protected]
Contact person for scientific queries
Name 78872 0
Dr Steven Howard
Address 78872 0
Early Start
University of Wollongong
Northfields Avenue
Wollongong, NSW
2522
Country 78872 0
Australia
Phone 78872 0
+61242215165
Fax 78872 0
Email 78872 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5753Study protocolHoward, S. J., Vasseleu, E., Neilsen-Hewett, C., & Cliff, K. (2018). Evaluation of the Preschool Situational Self-Regulation Toolkit (PRSIST) Program for Supporting Children's Early Self-Regulation Development: Study protocol for a cluster randomized controlled trial. Trials, 19, 64. doi: 10.1186/s13063-018-2455-4.  
5754Statistical analysis planHoward, S. J., Vasseleu, E., Neilsen-Hewett, C., & Cliff, K. (2018). Evaluation of the Preschool Situational Self-Regulation Toolkit (PRSIST) Program for Supporting Children's Early Self-Regulation Development: Study protocol for a cluster randomized controlled trial. Trials, 19, 64. doi: 10.1186/s13063-018-2455-4.  
5755Ethical approval    Ethics approval attached this registration. 373953-(Uploaded-14-11-2019-11-06-57)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIEvaluation of the Preschool Situational Self-Regulation Toolkit (PRSIST) Program for Supporting children’s early self-regulation development: study protocol for a cluster randomized controlled trial2018https://doi.org/10.1186/s13063-018-2455-4
N.B. These documents automatically identified may not have been verified by the study sponsor.