Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001705875
Ethics application status
Approved
Date submitted
28/10/2021
Date registered
13/12/2021
Date last updated
13/12/2021
Date data sharing statement initially provided
13/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of a Parent-Based Autonomy Support Program on Children’s Self-Regulation: A Pilot
Scientific title
The Effect of a Parent-Based Autonomy Support Program on Children’s Self-Regulation: A Pilot Randomised Control Trial (RCT)
Secondary ID [1] 305675 0
None
Universal Trial Number (UTN)
None
Trial acronym
PiP
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Self-regulation
324146 0
Early child development 324352 0
Condition category
Condition code
Mental Health 321620 321620 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PiP intervention will be a parent-focused program that teaches parents of pre-school children how and when to use autonomy supportive guiding behaviours during parent-child play. The PiP program will be spread across an 8-week period and consists of parent-only online knowledge sessions, parent-child in-person play workshops (held at an on-campus play space), and at-home play.

Knowledge sessions are intended to educate parents to improve their understanding of self-regulation and specific autonomy supportive practices shown to have a positive impact on self-regulation development. Topics covered in these sessions include (but not limited to) definitions of SR, what behaviours are indicative of children’s regulation and SR challenge, features of autonomy supportive behaviours, how and when autonomy support can be implemented, how parents can guide children with open-ended questions and encouraging statements, and how planning can support regulation development. Knowledge sessions are 45 min to 1 hour long, and are held online via Zoom, and are recorded. All parents are invited to attend either the live session held by the lead researcher, or watch the recording prior to the in-person workshop. The knowledge sessions are held every other week, totalling 4 sessions across the 8-week period. Attendance will be recorded in contribution to fidelity data.

During in-person play workshops parent-child dyads will engage in challenging play activities in which parents can practice autonomy support guiding strategies, individually coached by the researcher. The sessions are held every other week, totalling 4 sessions across the 8-week period. The session will start with a recap of the knowledge session for parents to ask any outstanding questions. The dyads will move to different play stations throughout the 90 minute workshop, culminating in a consolidation portion of the strategies while children free-play under the supervision of a research assistant. Play activities will align to characteristics that are conducive to SR growth (challenging, engaging, iterative). An example of a play activity is below:

Rainbow Pebbles Activity Set: children copy structures of varying degrees of challenge with the coloured ‘pebbles’ provided. Once a structure is completed the parent will be able to guide their child toward completing another, more difficult structure. During the completion of this task parents will utilise strategies that draw inspiration from the four features of autonomy support (which also inform the weekly theme of the knowledge sessions and workshops) to include: contingency, encouragement & using a helpful tone of voice, the hierarchy of autonomy support and creating challenge (as a feature of the task design).

At-home play: Parents will use these play episodes to continue to practise the principles and strategies from the online knowledge session and the in-person play workshops. Parents will be given a soft copy of a play-at-home calendar to track the time they spend engaged in parent-child play. Parents will be asked to play for a minimum of 60 minutes, every other week in between play workshops. Experiences of at-home play will be deconstructed during a reflection element of the online knowledge session that follows.
Intervention code [1] 322071 0
Behaviour
Comparator / control treatment
In efforts to match the minimum play dosage to the treatment group, parents in the control waitlist group will also be asked to engage in 1:1 play with their child at home, for a minimum of 60 minutes, every other week (same as the treatment group). Parents will also given a play-at-home calendar to track the time they spend engaged in parent-child play. Parents will not be invited to attend the knowledge sessions and the in-person play workshops.

Parent-child dyads in the waitlist control group will be invited to receive the PiP program upon completion of the evaluation to ensure equitable access and benefit for participation.
Control group
Active

Outcomes
Primary outcome [1] 329384 0
The primary outcome is parents' autonomy support behaviour, as indexed by the Maternal Autonomy Support Scale (Whipple et al, 2011) to be completed after a 10-minute observation of parents during a structured parent-child play task.
Timepoint [1] 329384 0
Baseline and 2 weeks post completion of intervention
Primary outcome [2] 329393 0
Parent's autonomy supportive behaviour in a free-play context. Parents and children will be shadowed for 15 minutes using the Early Start Discovery Space children's museum (at the University of Wollongong) and parent behaviour indexed by the Maternal Autonomy Support Scale adapted by Matte-Gagné et al. (2015).
Timepoint [2] 329393 0
At baseline and 2 weeks post completion of intervention
Secondary outcome [1] 402405 0
Children's self-regulation as indexed by performance on the Memory Card Game of the Preschool Situational Self-Regulation Toolkit (PRSIST, Howard et al. 2020). This game takes approximately 15 minutes to complete.
Timepoint [1] 402405 0
Baseline and 2 weeks post completion of intervention (at the same time as primary outcomes)
Secondary outcome [2] 402427 0
Children's self-regulation will also be measured in a free-play environment, and behaviour rated on the Regulated-Related Skills Measure (RRSM, McCoy, 2019). Children will play for approximately 15 minutes in a group setting with other children.
Timepoint [2] 402427 0
At baseline and 2 week post completion of intervention (at the same time as primary outcomes)

Eligibility
Key inclusion criteria
Children aged 3-5 years

Parents need to be able to speak fluent English with their child
Minimum age
3 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-English speaking participants
No other exclusion criteria

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)
Central randomisation via computer. Randomisation will occur after baseline data has been collected.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation to either intervention or control will be decided by central randomisation via computer, and therefore defined as simple randomisation procedures.
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
The sample size aim of 50 (25 participants per condition) is deemed feasible for execution by a single researcher, taking into account University face-to-face research protocol restrictions as a result of COVID-19.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/01/2021
Date of last participant enrolment
Anticipated
Actual
19/04/2021
Date of last data collection
Anticipated
Actual
24/06/2021
Sample size
Target
50
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 35787 0
2500 - Wollongong
Recruitment postcode(s) [2] 35788 0
2533 - Kiama
Recruitment postcode(s) [3] 35789 0
2534 - Gerringong

Funding & Sponsors
Funding source category [1] 310036 0
University
Name [1] 310036 0
Early Start Research Centre (PhD Scholarship) - University of Wollongong
Country [1] 310036 0
Australia
Funding source category [2] 310038 0
Charities/Societies/Foundations
Name [2] 310038 0
NSW Institute of Educational Research - Distinguished Student Grant
Country [2] 310038 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
University of Wollongong
Northfields Avenue
Wollongong
NSW
2500
Country
Australia
Secondary sponsor category [1] 311088 0
None
Name [1] 311088 0
None
Address [1] 311088 0
None
Country [1] 311088 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309736 0
UOW Social Sciences Human Research Ethics Committee
Ethics committee address [1] 309736 0
Ethics committee country [1] 309736 0
Australia
Date submitted for ethics approval [1] 309736 0
26/11/2020
Approval date [1] 309736 0
09/12/2020
Ethics approval number [1] 309736 0
2020/400

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

Contacts
Principal investigator
Name 115210 0
Ms Natalie Day
Address 115210 0
Early Start
Faculty of Arts, Social Sciences and Humanities
Office 204, Building 21
University of Wollongong
Wollongong
NSW
2500
Country 115210 0
Australia
Phone 115210 0
+61 426699228
Fax 115210 0
Email 115210 0
[email protected]
Contact person for public queries
Name 115211 0
Natalie Day
Address 115211 0
Early Start
Faculty of Arts, Social Sciences and Humanities
Office 204, Building 21
University of Wollongong
Wollongong
NSW
2500
Country 115211 0
Australia
Phone 115211 0
+61 426699228
Fax 115211 0
Email 115211 0
[email protected]
Contact person for scientific queries
Name 115212 0
Natalie Day
Address 115212 0
Early Start
Faculty of Arts, Social Sciences and Humanities
Office 204, Building 21
University of Wollongong
Wollongong
NSW
2500
Country 115212 0
Australia
Phone 115212 0
+61 426699228
Fax 115212 0
Email 115212 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data will be anonymous.
Parent autonomy support at baseline and post-test
Children's self-regulation at baseline and post-test
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years after publication
Available to whom?
Case-by-case basis at the discretion of the Principal Investigator
Available for what types of analyses?
To achieve aims of approved proposal
How or where can data be obtained?
Subject to approval by Principal Investigator - email [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13811Informed consent form  [email protected]
13812Ethical approval  [email protected]



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.