Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000485831
Ethics application status
Approved
Date submitted
13/11/2020
Date registered
26/04/2021
Date last updated
29/03/2022
Date data sharing statement initially provided
26/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Sports Stars: Adaptation of an introduction to sports group for children with disabilities into rural and remote contexts in Australia.
Scientific title
Sports Stars: Adaptation of a practitioner-led, peer-group sports intervention aimed at participation and activity competence for children with disabilities into rural and remote contexts in Australia.
Secondary ID [1] 302788 0
None
Universal Trial Number (UTN)
U1111-1261-1748
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood onset disability 319731 0
Condition category
Condition code
Physical Medicine / Rehabilitation 317669 317669 0 0
Physiotherapy
Physical Medicine / Rehabilitation 317670 317670 0 0
Occupational therapy
Musculoskeletal 318926 318926 0 0
Other muscular and skeletal disorders
Neurological 318927 318927 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 318928 318928 0 0
Down's syndrome
Human Genetics and Inherited Disorders 318929 318929 0 0
Other human genetics and inherited disorders
Injuries and Accidents 318930 318930 0 0
Other injuries and accidents
Metabolic and Endocrine 318931 318931 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children allocated to the immediate intervention group will receive the Sports Stars intervention from a physiotherapist or occupational therapist. Sports Stars is an eight-week peer-group intervention (1 hour per week) with 4-8 participants. It combines sports-specific gross motor activity training, sports education, teamwork development and confidence building with an introduction to four sports (e.g. soccer, netball, football, dance). Activities will be sport specific- e.g. for soccer will include dribbing and goal kicking drills. Intensity will vary from low-vigorous throughout the one hour session (RPE). Typically the first 10 minutes and last 5 minutes would be low intensity, the next 30 minutes would be moderate intensity an the final 10 minutes would be high intensity. Children will vary in the intensity of their participation and this will be self-moderated based on each child's participation. The variety of sports activities aims to provide opportunities for children to develop a wider range of (i) physical sports skills, (ii) knowledge and understanding of different sports, (iii) confidence in trying new sports and (iv) sports preferences. These sports are chosen based on what is available in the child’s local community. Fidelity of the intervention will be monitored through completion of session summary sheets for each child at each intervention session, as well as during weekly coaching calls to the practitioners by the lead investigator.
Intervention code [1] 319064 0
Rehabilitation
Comparator / control treatment
Children allocated to the waitlist control group will continue to receive standard care until after their follow-up assessment. For children with disabilities at this age this is expected to include physiotherapy or occupational therapy between 1-8 times within the 8-week intervention period. After 8 weeks they will be offered an opportunity to participate in the Sports Stars intervention.
Control group
Active

Outcomes
Primary outcome [1] 325716 0
Achievement of self-selected goals using a modified Canadian Occupational Performance Measure. Sports Stars participants will develop goals for participation and activity competence in collaboration with their parent/guardian and study researchers. This will include questions such as 'What kinds of sport or physical activities you would like to do, but are not currently doing?" These will be coded according to the Family of Participation-Related Constructs (attendance or involvement) and the Australian Physical Literacy framework (Physical, Social, Psychological or Cognitive competence).
Timepoint [1] 325716 0
0 weeks (pre-intervention) & 8 weeks (post intervention)
Secondary outcome [1] 388894 0
Parent report of frequency, diversity and intensity of participation in sport and/or physical recreation. This will be assessed using a study-specific questionnaire that collects information about the child's attendance (type, frequency, intensity, duration, competitive level) at sport and/or physical recreation and the child's level of involvement during attendance.
Timepoint [1] 388894 0
0 weeks (pre-intervention) & 8 weeks (post intervention)
Secondary outcome [2] 388895 0
Parent report of competence using the Australian Physical Literacy framework’s elements of competence under Physical, Social, Psychological and Cognitive domains.
Timepoint [2] 388895 0
0 weeks (pre-intervention) and 8 weeks (post intervention)
Secondary outcome [3] 388896 0
Test of Gross Motor Development- 3
Timepoint [3] 388896 0
0 weeks (pre-intervention) and 8 weeks (post intervention)
Secondary outcome [4] 388897 0
Standing broad jump: explosive leg power
Timepoint [4] 388897 0
0 weeks (pre-intervention) and 8 weeks (post intervention)
Secondary outcome [5] 392908 0
Child report of frequency, diversity and intensity of participation in sport and/or physical recreation. This will be assessed using a study-specific questionnaire that collects information about the child's attendance (type, frequency, intensity, duration, competitive level) at sport and/or physical recreation and the child's level of involvement during attendance.
Timepoint [5] 392908 0
0 weeks (pre-intervention) and 8 weeks (post-intervention)
Secondary outcome [6] 392909 0
Child report of competence using the Australian Physical Literacy framework’s elements of competence under Physical, Social, Psychological and Cognitive domains.
Timepoint [6] 392909 0
0 weeks (pre-intervention) and 8 weeks (post-intervention)

Eligibility
Key inclusion criteria
To be eligible for this research, children must:
• Be aged 6-12 years at commencement of the Sports Stars intervention
• Be diagnosed with a disability that includes a physical impairment
• Want to increase their participation in sport
• Be able to walk independently without aids (equivalent to GMFCS I-II)
• Be able to follow instructions and participate in a small group setting
• Be able to attend 8x1hour weekly Sports Stars sessions and two assessment sessions up to one hour (pre and post intervention) in their local community.
*Children’s primary parent/guardian must also be able to attend remote interviews via zoom or phone. A primary parent/guardian is considered to be the person who is most (or equally) aware of the child’s sports skills and current participation in sport.
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to participate safely in physical activity. E.g. due to uncontrolled epilepsy or a cardiac condition.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be determined by the off site chief investigator who is not involved in data collection or intervention. Allocation will occur using the sequence of allocation saved electronically and only accessible by the chief investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be pre-determined using a computer-based random number generator for each site.
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
All data will be analysed using the intention to treat principle. Descriptive statistics will be reported for baseline data for each variable (Sports Participation, Sports Goals and Sports Competence) to establish any difference between randomized groups. If characteristics are not comparable at baseline they will be modelled as covariates in subsequent analyses in order to adjust their possible confounding effects. Linear mixed models will be used to evaluate the effectiveness of the Sports stars intervention compared to the waitlist control on the primary outcome (Sports goals- COPM). Linear mixed models take it account variation in individuals over time, are able to manage missing data without excluding participants for further analysis and examine changes in the outcomes over time as well as across the two groups. Significance will be set at p<0.05. Residuals of the fitted models will be examined to ensure that all required assumptions are met.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/05/2021
Actual
12/05/2021
Date of last participant enrolment
Anticipated
1/08/2021
Actual
22/07/2021
Date of last data collection
Anticipated
31/01/2022
Actual
9/11/2021
Sample size
Target
18
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 307211 0
University
Name [1] 307211 0
Western Sydney University
Country [1] 307211 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 308879 0
None
Name [1] 308879 0
Address [1] 308879 0
Country [1] 308879 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307311 0
Western Sydney University
Ethics committee address [1] 307311 0
Ethics committee country [1] 307311 0
Australia
Date submitted for ethics approval [1] 307311 0
12/11/2020
Approval date [1] 307311 0
10/02/2021
Ethics approval number [1] 307311 0
H14166

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

Contacts
Principal investigator
Name 106786 0
Dr Georgina Clutterbuck
Address 106786 0
Western Sydney University
School of Health Sciences
Locked Bag 1797
Penrith NSW 2751
Country 106786 0
Australia
Phone 106786 0
+61 2 4620 3851
Fax 106786 0
Email 106786 0
[email protected]
Contact person for public queries
Name 106787 0
Georgina Clutterbuck
Address 106787 0
Western Sydney University
School of Health Sciences
Locked Bag 1797
Penrith NSW 2751
Country 106787 0
Australia
Phone 106787 0
+61 2 4620 3851
Fax 106787 0
Email 106787 0
[email protected]
Contact person for scientific queries
Name 106788 0
Georgina Clutterbuck
Address 106788 0
Western Sydney University
School of Health Sciences
Locked Bag 1797
Penrith NSW 2751
Country 106788 0
Australia
Phone 106788 0
+61 2 4620 3851
Fax 106788 0
Email 106788 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
9738Study protocol  [email protected]
9739Statistical analysis plan  [email protected]
9740Informed consent form  [email protected]
9741Ethical 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.