Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000549628
Ethics application status
Approved
Date submitted
13/05/2014
Date registered
22/05/2014
Date last updated
25/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Levelling the Playing Field: Promoting manageable risk taking in children with disabilities, starting with the school playground
Scientific title
A cluster randomized cross-over trial involving (a) risk reframing workshops for parents and primary school teachers and (b) introducing novel play materials on school playground for children to promote manageable risk taking in children with disabilities.
Secondary ID [1] 284588 0
nil
Universal Trial Number (UTN)
U1111-1156-7682
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
autism spectrum disorder 291881 0
developmental/learning disability 291882 0
hearing impairment 291883 0
Condition category
Condition code
Mental Health 292227 292227 0 0
Autistic spectrum disorders
Mental Health 292261 292261 0 0
Learning disabilities
Ear 292262 292262 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The program will have two arms: (1) risk reframing workshops to help parents and teachers distinguish manageable from unhealthy risk and recognise the benefits of manageable risktaking (e.g., becoming more responsible, vigilant) and (2) introducing materials with no obvious play value to the school playground to provide opportunities for adults and children to practice promoting and engaging in manageable risk-taking in the context of social, creative and active play.
Risk Reframing workshops: 3 workshops will be provided each lasting 2 hours in duration. The focus of the workshop is on helping parents and teachers distinguish manageable from unhealthy risk-taking and recognize the benefits of manageable risk-taking (e.g., becoming more responsible, vigilant). Our previous research findings indicated that parents and teachers would benefit from follow up workshops. Two sessions have been added to this intervention to allow for continued discussion among participants about their experiences of risk reframing.
Playground Materials:introducing materials with no obvious play value to the school playground to provide opportunities for adults and children to practice promoting and engaging in manageable risk-taking in the context of social, creative and active play. Play materials will meet 7 criteria: 1) are, or are made from, re-cycled materials; 2) have no obvious play value; 3) encourage cooperative, gross motor play; 4) have multiple uses; 5) promote challenging and creative play; 6) provide interesting sensory experiences (e.g., from touch or movement); and 7) any hazards inherent to the materials can easily be identified and managed by a child. New materials will be introduced periodically to replace broken items and complement existing materials. Maintenance of the materials will be the joint responsibility of the researchers and school staff.
Two groups (consisting of 3 schools in each group) will each receive both components of the intervention. Three schools will receive the intervention first and three schools will receive the intervention second. Each program will engage in 2 rounds of intervention over 2 years. In Round 1, interventions will be introduced after a 2-term delay or withdrawn for 2 terms (depending on group membership). In Round 2, each program will retain the materials uninterrupted for 3 terms.
Time frame: The study will take place over 3 years. Two schools will be involved in each year. Following a short (1-2 week) baseline when pretest measures will be taken, each of the schools will engage in both intervention and control phases; only the order (intervention first or control first) will be different. Schools that have intervention first will be involved in project activities for 2 terms followed by 2 terms when the research team collects data but no other project activities occur. For the other schools, it will be the opposite: 2 terms of data collection only followed by 2 terms of project activities. We will decide which schools are in which group by lottery. A school term is approximately 2.5 months in duration and two terms is approximately 5 months. Therefore intervention period is approx. 5 months + control period approx. 5 months. The risk reframing sessions with adults will take place at the outset of the intervention for each school (e.g., week 1) and follow-up sessions will occur at the mid-point (e.g., after two months of intervention, approximately week 10) and again near the end (e.g., approximately week 19). Scheduling the risk reframing sessions will require a degree of flexibility to ensure opportunity for participants to attend.
Intervention code [1] 289361 0
Behaviour
Comparator / control treatment
We will employ a cluster randomised cross-over trial with each of 6 programs representing a cluster. Because programs for children with disabilities differ substantially, each will serve as its own control. On entry to the study each program will be assigned randomly to a “Baseline First” or “Intervention First”
group (3 programs/group). To examine sustainability of the intervention, each program will participate for 2 years.
Six Sydney-area primary-school-based programs for children with disabilities will participate. Administrators from several programs have expressed eagerness to participate: ASPECT
(multiple satellite schools for children with autism), Giant Steps School (children with autism), St Gabriel’s School (children with hearing impairments and other developmental disabilities), Madang Avenue Public (special unit; children with developmental disabilities) and Auburn Public (special unit; children with
developmental disabilities). The control arm of the research involves two terms of no intervention.
Control group
Active

Outcomes
Primary outcome [1] 292096 0
Adults’ promotion of manageable risk taking and children’s increasingly responsible actions on the playground
Hypothesis: significant increases in - Ratio of time spent in positive play transactions* to time spent in negative transactions** (primary measure derived from modified SOPLAY
described below as the Playground Observation System).
Playground Observation System. Implemented daily during recess across both intervention and no intervention phases. Following procedures from a modified version of the System for Observing Play and Leisure Activity in Youth (SOPLAY), a researcher will record (1x/min) on a specially designed tablet
(backed up by a surveillance camera), the nature and type of activities in which children and adults engage in the space during lunch/recess. SOPLAY has evidence for very good to excellent inter-observer reliabilities, ranging from 88% to 97% agreement (m = 94%) on each of 5 contextual variables. We will train raters and check reliability periodically to avoid rater drift. We will use these findings to calculate the primary outcome: ratio of time in positive play transactions to time in negative transactions
Timepoint [1] 292096 0
At regularly scheduled intervals on a weekly basis throughout the intervention phase a researcher will record (1x/min) on a specially designed tablet (backed up by a surveillance camera), the nature and type of activities in which children and adults engage in the space during lunch/recess.
Primary outcome [2] 292097 0
Child coping ability assessed by Mean scores on the Coping Inventory - An observation instrument used to assess the behaviour patterns and skills that are the resources a child uses to meet personal needs and to adapt to the demands of the environment. A 48-item scale completed by regular caregivers of children aged 3-16. Factor analysis revealed evidence for one factor accounting for 75% of the variance; high correlation with school achievement (California Achievement Tests; r = .71);
significant but low correlations with self concept (Piers Harris; r = .17); interrater reliability r = .90 to .92; internal consistency alpha = .84 to .98; SEm Ëś .03.
Timepoint [2] 292097 0
Completed by teachers at the beginning and end of each study phase.
Primary outcome [3] 292098 0
Parents’ and teachers’ comfort with children
taking manageable risks. Measured by Mean scores on the Tolerance of Risk in Play Scale (TRiPS) and a revised Willingness to Grant Autonomy Scale.
TRiPs: A 32-item scale completed by parents for children aged 2 to 12. Rasch analysis revealed excellent evidence for
internal construct validity (goodness of fit within acceptable range for all items) and reliability (person separation 2.63; reliability index= 0.87) and near perfect correlation with child age.
Willingness to Grant Autonomy Scale: A 15-item questionnaire completed by parents regarding how much they want to share control with their adolescent. We will incorporate some age-appropriate questions from this scale into the TRiPs.
Timepoint [3] 292098 0
Completed by parents and teachers at the beginning and end of each study phase.
Secondary outcome [1] 308202 0
Perceptions of parents and teachers regarding manageable risk taking and children’s abilities to assume responsibility
Qualitative Evidence: In-depth (~ 1 hour), semi-structured interviews with 36 parents and teachers (6 total/program) nominated by principals and purposely selected to represent a range of opinions about the value of the program or tolerance of risk. Qualitative interviewing is an optimal way to understand the
subjective experiences and world views of participants. We will adhere to accepted procedures to ensure trustworthiness of the data (e.g., triangulation. journalling).
Timepoint [1] 308202 0
Interview data. Interviews will be conducted approximately 2 months after the final risk reframing intervention.

Eligibility
Key inclusion criteria
Clusters (Programs). Six Sydney-area primary-school-based programs for children with disabilities will participate. Administrators from several programs have expressed eagerness to participate: ASPECT (multiple satellite schools for children with autism), Giant Steps School (children with autism), St Gabriel’s School (children with hearing impairments and other developmental disabilities), Madang Avenue Public
(special unit; children with developmental disabilities) and Auburn Public (special unit; children with developmental disabilities). All of the ~200 children enrolled in the 6 programs, their teachers and parents will participate.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
n/a

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)
6 Schools have been identified as eligible to participate. From these 6 schools, two schools will participate each year. Both will receive the intervention. Randomisation will simply determine whether they receive the intervention condition or the control condition first. The two schools involved will be randomized either to control-first or intervention-first by coin toss conducted by a person uninvolved in the study. Determination of which two schools will participate in a given year will be determined also by lottery (drawing names from a hat).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedure: Each year, following a short baseline, the two schools involved will be randomized either to control-first or intervention-first by coin toss conducted by a person uninvolved in the study
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Introduction of Play materials on school playgrounds: We will conduct the study over 3 years. Each program will engage in 2 rounds of intervention over 2 years. In Round 1, interventions will be introduced after a 2-term delay or withdrawn for 2 terms (depending on group membership). In Round 2, each program will retain the materials uninterrupted for 3 terms.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/06/2014
Actual
Date of last participant enrolment
Anticipated
5/06/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289222 0
Government body
Name [1] 289222 0
Australian Research Council
Country [1] 289222 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 287893 0
None
Name [1] 287893 0
Address [1] 287893 0
Country [1] 287893 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290989 0
Human Research Ethics Board, Faculty of Health Sciences, University of Sydney
Ethics committee address [1] 290989 0
Ethics committee country [1] 290989 0
Australia
Date submitted for ethics approval [1] 290989 0
16/02/2014
Approval date [1] 290989 0
08/04/2014
Ethics approval number [1] 290989 0
2014/155

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

Contacts
Principal investigator
Name 48310 0
Prof Anita Bundy
Address 48310 0
C43J - J Block of Cumberland Campus
Cumberland Campus C42, The University of Sydney, NSW, 2006
Country 48310 0
Australia
Phone 48310 0
+61 2 9351 9857
Fax 48310 0
+61 2 9351 9198
Email 48310 0
[email protected]
Contact person for public queries
Name 48311 0
Michelle Villeneuve
Address 48311 0
J106, Cumberland Campus C42, The University of Sydney, NSW, 2006
Country 48311 0
Australia
Phone 48311 0
+61 2 9356 7438
Fax 48311 0
Email 48311 0
[email protected]
Contact person for scientific queries
Name 48312 0
Anita Bundy
Address 48312 0
C43J - J Block of Cumberland Campus
Cumberland Campus C42, The University of Sydney, NSW, 2006
Country 48312 0
Australia
Phone 48312 0
+61 2 9351 9857
Fax 48312 0
Email 48312 0
[email protected]

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Sydney playground project--levelling the playing field: a cluster trial of a primary school-based intervention aiming to promote manageable risk-taking in children with disability.2015https://dx.doi.org/10.1186/s12889-015-2452-4
N.B. These documents automatically identified may not have been verified by the study sponsor.