Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000600448
Ethics application status
Approved
Date submitted
23/05/2025
Date registered
11/06/2025
Date last updated
11/06/2025
Date data sharing statement initially provided
11/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
AllPlay Dance Autism: A randomised controlled trial of a community-based dance program for Autistic children
Scientific title
AllPlay Dance Autism: A randomised controlled trial of the effect of a community-based dance program on motor functioning for Autistic children
Secondary ID [1] 314518 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a full-scale RCT based on the pilot study (ACTRN12619000671167), which assessed the feasibility and acceptability of the AllPlay Dance program for autistic children.

Health condition
Health condition(s) or problem(s) studied:
Autism 337606 0
Condition category
Condition code
Mental Health 333946 333946 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The AllPlay Dance program aims to ensure that children with disability and developmental conditions can access dance classes in the community (see allplaydance.org.au). The program was designed and will be delivered by dance and disability experts with more than 20 years of professional dance performance experience and/or experience in research, clinical practice, and teaching dance in the disability and autism field. It will be delivered at a dance studio located at Deakin University, Burwood campus. The current intervention focuses on autism and consists of 8 weekly 50-minute dance sessions plus a final 100-minute session in the 9th week, which includes a rehearsal and an informal performance. Families will receive orientation material before the first dance class to familiarise them with the program. The sessions will follow a consistent structure. After a warm-up incorporating both set movement material and improvisation, children will work in pairs or small groups on common creative tasks. After this, they will come back together to show their dances and watch each other (see Millard et al.., 2021 for a full description). All dance classes will be adapted to the child’s needs, and alternative movement variations and participation options will be provided to cater to the child's strengths. During each session, children are paired with older dancers, ‘buddies’, who support their participation through dancing and collaborating with them in creative exercises. These buddies will predominantly be university students enrolled in Dance units at Deakin University. Buddies will complete AllPlay Dance’s professional development training and attend an online briefing session prior to supporting children. Intervention adherence will be assessed by the research team through self-report and attendance logs.
Intervention code [1] 331148 0
Lifestyle
Intervention code [2] 331149 0
Behaviour
Comparator / control treatment
Treatment-as-usual (TAU) waitlist control. The TAU control group will be able to continue with their medical appointments and non-dance-related activities throughout the study. They will be offered the AllPlay Dance intervention 4 weeks after the final AllPlay Dance session for the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 341593 0
Changes in motor functioning
Timepoint [1] 341593 0
Baseline and post-intervention (within 4 weeks of the final session)
Primary outcome [2] 341594 0
Changes in motor functioning
Timepoint [2] 341594 0
Baseline and post-intervention (within 4 weeks of the final session)
Secondary outcome [1] 448021 0
Changes in social functioning
Timepoint [1] 448021 0
Baseline and post-intervention (within 4 weeks of the final session)
Secondary outcome [2] 448022 0
Changes in executive functioning
Timepoint [2] 448022 0
Baseline and post-intervention (within 4 weeks of the final session)
Secondary outcome [3] 448023 0
Changes in emotional and behavioural functioning
Timepoint [3] 448023 0
Baseline and post-intervention (within 4 weeks of the final session)
Secondary outcome [4] 448024 0
Changes in parental stress
Timepoint [4] 448024 0
Baseline and post-intervention (within 4 weeks of the final session)
Secondary outcome [5] 448025 0
Acceptability of AllPlay Dance for families
Timepoint [5] 448025 0
Baseline and post-intervention (within 4 weeks of the final session)
Secondary outcome [6] 448026 0
Feasibility of AllPlay Dance for families
Timepoint [6] 448026 0
Baseline, during the 9-week intervention period, and post-intervention (within 4 weeks of the final session)
Secondary outcome [7] 448364 0
Acceptability of AllPlay Dance for buddies
Timepoint [7] 448364 0
Baseline and post-intervention (within 4 weeks of the final session)
Secondary outcome [8] 448366 0
Feasibility of AllPlay Dance for buddies
Timepoint [8] 448366 0
Baseline, during the 9-week intervention period, and post-intervention (within 4 weeks of the final session)
Secondary outcome [9] 448367 0
Follow-up of participation in community-based dance
Timepoint [9] 448367 0
Three months after completion of the intervention
Secondary outcome [10] 448368 0
Follow-up of experiences in community-based dance
Timepoint [10] 448368 0
Three months after completion of the intervention

Eligibility
Key inclusion criteria
For children:
1. Aged between 7 years to 12 years and 11 months at the time of randomisation
2. Pre-existing formal Autism diagnosis without a co-occurring diagnosis of intellectual disability
3. Able to understand and follow simple verbal and visual instructions
4. Available to attend the dance program in Term 3 (2025) or Term 1 (2026) if randomly allocated to the intervention group
4. Have not previously participated in a similar dance program in the community on an ongoing basis
5. Will not commence any other dance program during the 13-week intervention and data collection period
6. Living in Victoria, Australia

For parents:
1. Parent/guardian of a child with a diagnosis of Autism who is involved in the study
2. Sufficient English proficiency to provide informed consent and complete questionnaires

For buddies
1. Are currently/have previously completed training in dance
2. Have a working with children check
3. Are available to support at least one group of children through the dance program
4. Sufficient English proficiency to provide informed consent and complete questionnaires
5. Living in Victoria, Australia
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation schedule will be pre-generated and loaded into the REDCap Online platform by an independent research statistician. Block randomisation (of various sizes) with a 1:1 ratio between groups, stratified by parent-reported child gender, will be used. Families with siblings enrolled in the RCT will be randomised in sequence based on the return of the primary caregiver's baseline surveys, with all subsequent siblings allocated to the same treatment group arm.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We aim to recruit approximately 60 families to ensure adequate statistical power while accounting for potential attrition. We also plan to recruit up to 60 buddies to support program delivery, with a target ratio of one buddy per one to two children. There may be occasions where the ratio extends to 1:3. Both qualitative and quantitative analyses will be conducted. Quantitative analyses will likely include mixed ANOVAs to assess changes in key outcome measures across time (pre- and post-intervention) and between groups (intervention vs control). Where appropriate, we will also explore change scores in relation to minimal clinically important differences (MCIDs) and other relevant benchmarks for interpreting meaningful change. Qualitative and descriptive analyses will be used to assess the feasibility and acceptability of the program and to explore participants’ experiences, including engagement with community dance classes following the intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/06/2025
Actual
Date of last participant enrolment
Anticipated
25/01/2026
Actual
Date of last data collection
Anticipated
19/07/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 319062 0
Commercial sector/Industry
Name [1] 319062 0
Mecca M-Power - Funding for the AllPlay Footy and AllPlay Dance research programs
Country [1] 319062 0
Australia
Funding source category [2] 319063 0
Charities/Societies/Foundations
Name [2] 319063 0
Grace and Emilio Foundation - AllPlay Dance Breaking Down the Barriers to Inclusion
Country [2] 319063 0
Australia
Funding source category [3] 319064 0
Government body
Name [3] 319064 0
Australian Government Research Training Program (RTP) Scholarship
Country [3] 319064 0
Australia
Funding source category [4] 319065 0
Commercial sector/Industry
Name [4] 319065 0
Mecca M-Power Top-Up Scholarship
Country [4] 319065 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 321526 0
None
Name [1] 321526 0
Address [1] 321526 0
Country [1] 321526 0
Other collaborator category [1] 283533 0
University
Name [1] 283533 0
Deakin University
Address [1] 283533 0
Country [1] 283533 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317663 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 317663 0
Ethics committee country [1] 317663 0
Australia
Date submitted for ethics approval [1] 317663 0
14/04/2025
Approval date [1] 317663 0
20/05/2025
Ethics approval number [1] 317663 0
Ethics committee name [2] 317664 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [2] 317664 0
Ethics committee country [2] 317664 0
Australia
Date submitted for ethics approval [2] 317664 0
Approval date [2] 317664 0
02/06/2025
Ethics approval number [2] 317664 0

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

Contacts
Principal investigator
Name 141746 0
Prof Nicole Rinehart
Address 141746 0
Monash University - 18 Innovation Walk, Clayton VIC 3168
Country 141746 0
Australia
Phone 141746 0
+61 411 623 297
Fax 141746 0
Email 141746 0
[email protected]
Contact person for public queries
Name 141747 0
Nicole Rinehart
Address 141747 0
Monash University - 18 Innovation Walk, Clayton VIC 3168
Country 141747 0
Australia
Phone 141747 0
+61 411 623 297
Fax 141747 0
Email 141747 0
[email protected]
Contact person for scientific queries
Name 141748 0
Nicole Rinehart
Address 141748 0
Monash University - 18 Innovation Walk, Clayton VIC 3168
Country 141748 0
Australia
Phone 141748 0
+61 411 623 297
Fax 141748 0
Email 141748 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


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.