Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000405910
Ethics application status
Approved
Date submitted
11/03/2020
Date registered
25/03/2020
Date last updated
14/12/2022
Date data sharing statement initially provided
25/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet-Based Professional Learning to Help Teachers Promote Activity in Youth with Intellectual Disability. The iPLAY For Inclusion Project: iPLAY4i
Scientific title
Internet-Based Professional Learning to Help Teachers Promote Activity in Youth with Intellectual Disability. The iPLAY For Inclusion Project: iPLAY4i: The iPLAY4I Cluster Randomised Control Trial.
Secondary ID [1] 300747 0
Nil
Universal Trial Number (UTN)
Trial acronym
iPLAY4i
Linked study record
Parent study: ACTRN12616000731493

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity in children with intellectual disabilities. 316587 0
Decline in cardiorespiratory fitness. 316588 0
Condition category
Condition code
Public Health 314817 314817 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention aims to build upon two studies conducted with students in mainstream classes (Cohen et al. 2015; Lonsdale et al. 2016). These previous implementations included six components to promote physical activity participation and fundamental movement skill competency. iPLAY for inclusion will include similar components, but will include additional content on positive behaviour support (MacDonald and McGill 2013) and universal design for learning (Ok et al. 2017).

As per previous studies (Lonsdale et al. 2016), an iPLAY mentor (employed by the project team) will deliver a professional learning workshop and follow-up individualized mentoring to primary teachers. These activities will be supported by an online learning and resource platform (following Lonsdale et al. 2016). Teachers within the schools will then deliver intervention components. All classroom teachers will deliver curricular components of the intervention (e.g., quality PE and school sport). The curricular components are largely built around making classes SAAFE (Lubans et al. 2017): Supportive, Active, Autonomous, Fair and Enjoyable. Within each school the principal will identify up to three classroom teachers as ‘Leaders’. Leaders will deliver non-curricular components of the intervention (e.g., active playgrounds) and support other teachers with the implementation of curricular components.

Mentors will be current and recently retired teachers with NSW Education Standards Authority (NESA) specialist accreditation in Health and PE. These specialist teachers are ideally placed to deliver the intervention as primary school teachers will regard them as credible. During 2.5 days of face-to-face workshops, the project team will train mentors to deliver the intervention.
Intervention code [1] 317074 0
Lifestyle
Intervention code [2] 317075 0
Behaviour
Intervention code [3] 317078 0
Prevention
Comparator / control treatment
Wait-list control: after the intervention period, and following post-test data collection, the control schools will be offered the intervention.
Control group
Active

Outcomes
Primary outcome [1] 323173 0
Fundamental Movement Skills measured by competence on the 'Test of Gross Motor Development-3 (Webster & Ulrich, 2017). We will include the three skills for each subscale that explained the most variance in children with intellectual disabilities (see Magistro et al., 2018; Simons et al., 2008). The primary outcome will be the raw score, totalled across both trials of all six skills: run, gallop, hop, one-hand strike, dribble, and kick.
Timepoint [1] 323173 0
Baseline and 21 months post-baseline
Secondary outcome [1] 381033 0
Cardiorespiratory fitness. This will be measured with a 300-yard run where children will be asked to run or walk as fast as they can over 300 yards (timed). This time will be our indicator of cardiorespiratory fitness.
Timepoint [1] 381033 0
Baseline and 21 months post-baseline
Secondary outcome [2] 381089 0
Physical Activity. We will also use an objective measure (GENEActiv wrist-worn accelerometers) for seven days to measure students' physical activity at home and in school.
Timepoint [2] 381089 0
Baseline and 21 months post-baseline
Secondary outcome [3] 381090 0
Students will also be asked questions about their physical self-concept via individual administration of the self-description questionnaire, individual administration (SDQ-IA physical subscale; Marsh et al., 2005; Tracey & Marsh, 2000). We selected the six items of the physical self-concept subscale that did not overlap with the enjoyment measure, described below. In the individual administration version, students are guided by a researcher to first ask whether they agree with the statement, then asked to what extent. We chose this response mechanism for all other assessments for consistency and because it has been validated in children with intellectual disability (Tracey & Marsh, 2000). Students will use this response scale to report on their enjoyment for physical activity and their life satisfaction. For enjoyment, three items were chosen from the Physical Activity Enjoyment Scale (e.g., “I enjoy sport and PE”; Motl et al., 2001). For life-satisfaction, students will rate their wellbeing on the personal wellbeing index for intellectual disability (Cummins & Lau, 2005), using the single-item measure of life satisfaction because it has been shown to demonstrate comparable validity to longer measures (Cheung & Lucas, 2014).
Timepoint [3] 381090 0
Baseline and 21 months post-baseline

Eligibility
Key inclusion criteria
Government primary schools will be invited to participate on the basis of the following criteria:
School is within 3 hours of our university
School has not previously completed our iPLAY
School has 10 or more children with intellectual disabilities in Years 2–5

In those schools, all teachers will be eligible to participate in professional learning, with student-level data only collected from children with intellectual disabilities in Years 2–5.
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with intellectual disabilities will be excluded under two circumstances. 1] Children will be excluded if they have a physical disability that precludes them from running. Children with mild physical disabilities will still be eligible, because these disabilities are often comorbid with intellectual disabilities. For example, children in wheelchairs would be excluded, but children with mild cerebral palsy would be included. Similarly, children will still be eligible if they have mild, comorbid developmental disorders (e.g., level 1 Autism Spectrum Disorder, mild Childhood-Onset Fluency Disorder); however, 2] children will be excluded if their developmental disorder precludes them from responding to verbal questions (e.g., level 2 and 3 Autism Spectrum Disorder would be excluded based on this criteria).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be performed by a random number generator by a statistician that is not part of the team. As a result, the person enrolling schools will not be able to foresee the treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Schools will be randomised in waves as they are recruited. When schools are recruited, they will be matched on school type (mainstream vs. schools for special purposes), Index of Community Socio-Educational Advantage (ICSEA), and location (urban vs. remote). Schools will first be matched on all three criteria. Then, schools will be matched on two out of the three criteria. Then, an experienced statistician who is not part of the research team will use a computer-generated algorithm (Moore & Schnakenberg, 2016) to randomised matched schools.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To assess pre-post differences on all student-reported variables, we will use linear mixed models. Student scores will be nested within teachers and we will account for this via a random intercept. We will assess the interaction between treatment and time on gross fundamental movement skill competency. We hypothesise that the influence of time on competency will be greater for those in the intervention group. This process will also be used to assess intervention effects for all secondary outcomes (i.e., cardio-respiratory fitness, self-concept, motivation, wellbeing, physical activity). We will conduct sensitivity analyses to assess whether findings are robust when controlling for demographic variables. We’ll also conduct an as-per-protocol analysis by assessing whether completion of the professional learning moderates the effect of the intervention. Rather than using an arbitrary cut-off, we will use learning analytics to identify the percentage of the course that teachers completed at post-test. We will then assess whether this percentage explains variance in the effect of the program on their students. Using full information maximum likelihood to account for attrition, our data will follow intention-to-treat procedures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2020
Actual
28/10/2020
Date of last participant enrolment
Anticipated
3/07/2020
Actual
7/12/2020
Date of last data collection
Anticipated
20/10/2022
Actual
16/09/2022
Sample size
Target
115
Accrual to date
Final
210
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305185 0
Government body
Name [1] 305185 0
Sport Australia
Country [1] 305185 0
Australia
Funding source category [2] 305201 0
Government body
Name [2] 305201 0
New South Wales Department of Education School Sport Unit
Country [2] 305201 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
ACU North Sydney Campus
Motivation and Behaviour Research Program
Level 9, 33 Berry Street
North Sydney
2060
Australia.
Country
Australia
Secondary sponsor category [1] 305572 0
University
Name [1] 305572 0
Western Sydney University
Address [1] 305572 0
Horsley Rd & Bullecourt Ave,
Milperra NSW 2214
Country [1] 305572 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305541 0
State Education Research Applications Process
Ethics committee address [1] 305541 0
Ethics committee country [1] 305541 0
Australia
Date submitted for ethics approval [1] 305541 0
17/05/2019
Approval date [1] 305541 0
08/08/2019
Ethics approval number [1] 305541 0
2019289
Ethics committee name [2] 305556 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [2] 305556 0
Ethics committee country [2] 305556 0
Australia
Date submitted for ethics approval [2] 305556 0
06/06/2019
Approval date [2] 305556 0
06/08/2019
Ethics approval number [2] 305556 0
2019-106H.

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

Contacts
Principal investigator
Name 100726 0
Prof Chris Lonsdale
Address 100726 0
Institute for Positive Psychology and Education
Australian Catholic University
Level 9,
33 Berry Street,
North Sydney,
NSW, 2060
Country 100726 0
Australia
Phone 100726 0
+61 2 9701 4642
Fax 100726 0
Email 100726 0
[email protected]
Contact person for public queries
Name 100727 0
Michael Noetel
Address 100727 0
School of Behavioural and Health Sciences (Qld)
Building 208
Level 2
1100 Nudgee Road
Banyo QLD 4014
Country 100727 0
Australia
Phone 100727 0
+61 736237256
Fax 100727 0
Email 100727 0
[email protected]
Contact person for scientific queries
Name 100728 0
Michael Noetel
Address 100728 0
School of Behavioural and Health Sciences (Qld)
Building 208
Level 2
1100 Nudgee Road
Banyo QLD 4014
Country 100728 0
Australia
Phone 100728 0
+61 736237256
Fax 100728 0
Email 100728 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?
De-identified results of all assessments
When will data be available (start and end dates)?
Pre/post data will be available from the end of 2021 with no end-point determined
Available to whom?
On a case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
For IPD meta-analyses
How or where can data be obtained?
Via RedCAP


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7293Study protocol  [email protected] 379417-(Uploaded-11-03-2020-12-48-39)-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
No additional documents have been identified.