Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000823572
Ethics application status
Approved
Date submitted
12/06/2024
Date registered
4/07/2024
Date last updated
4/07/2024
Date data sharing statement initially provided
4/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring impacts of a codesigned program mapping physical activities to personalised goals for children with autism
Scientific title
Mapping physical activities to goals for children with autism: codesigned program feasibility and efficacy
Secondary ID [1] 312327 0
Spinnaker Health Research Foundation/Telethon 2023 Grant (REF #2024-EF-RETRO-001-83100-SHRF)
Universal Trial Number (UTN)
Trial acronym
ExAut
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 334086 0
autistic spectrum disorders 334085 0
Condition category
Condition code
Physical Medicine / Rehabilitation 330764 330764 0 0
Other physical medicine / rehabilitation
Mental Health 330763 330763 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention comprises a codesigned, progressive physical activity program (PAP) for children with autism spectrum disorders (ASD).

The PAP will be codesigned by the participant, their parent or carer, and the researchers. The specific activities offered will aim to address the physical and mental health goals identified by the participant and their parent.

The PAP will comprise individual and group activity options, including: aerobic activities; resistance exercise; balance-coordination activities; ball sports; and concurrent at-home activities. PAP delivery will be multi-modal, including supervised face-to-face sessions and home-based activities.

Supervised physical activity sessions will take place at the MindBody Lab, Murdoch University in the Perth (Australia) metropolitan area. Materials for the PAP including sport equipment (e.g., cones, line markers, resistance bands, balls) and a speaker for music.

Sessions will comprise a minimum two, ~45 min sessions per week for eight weeks. Sessions will include multimodal exercises combining resistance exercises (e.g., some weight equipment), reaction type exercises (e.g., responding to some stimuli), fundamental movements (e.g., skipping, hopping jumping, balancing, catching and throwing), endurance exercises (e.g., rowing ergometer, cycling ergometer, treadmill or outdoor running) and coordinated sports activities (e.g., basketball, soccer etc.). Composition of exercises will be individualised for each person using their age, functional capacity, preferred exercises and activities, as well as preferred outcomes.

Participating children will be required to wear an actigraphy device (Axivity, 100 Hz) on their wrist, allowing researchers to monitor adherence to the home-based PA components. Supervised session attendance will also be recorded by the researchers.

The PAP will be delivered by qualified exercise physiologists with experience conducting PA sessions with children and current First Aid qualifications. Physical assessments will be conducted by qualified exercise physiologists. Psychological and mental health assessments will be conducted by qualified psychology researchers. All researchers with direct contact with children will have current working with children checks – Western Australia (WWCC-WA) and Western Australian police clearance.

Researchers will contact the participant families regularly via participant-preferred modes for session scheduling, adherence checks, and to answer general queries.
Intervention code [1] 328808 0
Lifestyle
Intervention code [2] 328809 0
Behaviour
Intervention code [3] 328807 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338520 0
physical activity engagement
Timepoint [1] 338520 0
week 0, week 4 (midpoint), week 8
Primary outcome [2] 338523 0
Preferences for physical activity type
Timepoint [2] 338523 0
week 0, week 8
Primary outcome [3] 338521 0
self-reported health
Timepoint [3] 338521 0
week 0, week 4 (midpoint), week 8
Secondary outcome [1] 436526 0
Preferences for physical function assessments
Timepoint [1] 436526 0
week 0, week 8
Secondary outcome [2] 436268 0
social communication
Timepoint [2] 436268 0
week 0, week 8
Secondary outcome [3] 436270 0
cognitive capabilities
Timepoint [3] 436270 0
week 0, week 8
Secondary outcome [4] 436267 0
sleep quantity
Timepoint [4] 436267 0
week 0, week 4 (midpoint), week 8
Secondary outcome [5] 436271 0
receptive vocabulary
Timepoint [5] 436271 0
week 0, week 8
Secondary outcome [6] 436264 0
muscular strength
Timepoint [6] 436264 0
week 0, week 4 (midpoint), week 8
Secondary outcome [7] 436263 0
cardiorespiratory fitness
Timepoint [7] 436263 0
week 0, week 4 (midpoint), week 8
Secondary outcome [8] 436525 0
Sleep quality
Timepoint [8] 436525 0
week 0, week 4 (midpoint), week 8

Eligibility
Key inclusion criteria
Diagnosis: autism spectrum disorder (ASD)
Geographic location: Perth metropolitan area
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unable to communicate effectively, unable to participate in physical activity, unable to attend intervention sessions

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 20 children will participate in this study.

A mixed methods approach will be used to analyse the data for this study. Qualitative analysis will be used to identify themes of PA barriers and facilitators. Quantitative analysis will be used to analyse changes to physical and mental health outcomes, as well as changes to ASD traits. Specific analytical techniques will include univariate repeated measured designs or linear mixed models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2024
Actual
Date of last participant enrolment
Anticipated
20/12/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 316724 0
Charities/Societies/Foundations
Name [1] 316724 0
Channel 7 Telethon Trust
Country [1] 316724 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Spinnaker Health Research Foundation
Address
Country
Australia
Secondary sponsor category [1] 318929 0
Charities/Societies/Foundations
Name [1] 318929 0
The Hospital Research Foundation Group
Address [1] 318929 0
Country [1] 318929 0
Australia
Secondary sponsor category [2] 318930 0
Charities/Societies/Foundations
Name [2] 318930 0
Murdoch University
Address [2] 318930 0
Country [2] 318930 0
Australia
Other collaborator category [1] 283095 0
Individual
Name [1] 283095 0
Dr Brook Galna
Address [1] 283095 0
Country [1] 283095 0
Australia
Other collaborator category [2] 283096 0
Individual
Name [2] 283096 0
Dr Shu Yau
Address [2] 283096 0
Country [2] 283096 0
Australia
Other collaborator category [3] 283094 0
Individual
Name [3] 283094 0
Dr Shailander Mehta
Address [3] 283094 0
Country [3] 283094 0
Australia
Other collaborator category [4] 283086 0
Individual
Name [4] 283086 0
Stephanie Dowden
Address [4] 283086 0
Country [4] 283086 0
Australia
Other collaborator category [5] 283085 0
Individual
Name [5] 283085 0
Dr Ben Jackson
Address [5] 283085 0
Country [5] 283085 0
Australia
Other collaborator category [6] 283092 0
Individual
Name [6] 283092 0
Dr Janine Spencer
Address [6] 283092 0
Country [6] 283092 0
Australia
Other collaborator category [7] 283093 0
Individual
Name [7] 283093 0
Wendy McCafferty
Address [7] 283093 0
Country [7] 283093 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315499 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 315499 0
Ethics committee country [1] 315499 0
Australia
Date submitted for ethics approval [1] 315499 0
29/02/2024
Approval date [1] 315499 0
17/05/2024
Ethics approval number [1] 315499 0
2024/046

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

Contacts
Principal investigator
Name 134890 0
A/Prof Timothy Fairchild
Address 134890 0
School of Allied Health, Murdoch University, 90 South Street, Murdoch, WA, 6150
Country 134890 0
Australia
Phone 134890 0
+61 8 9360 2959
Fax 134890 0
Email 134890 0
[email protected]
Contact person for public queries
Name 134891 0
Stephanie Bovell
Address 134891 0
School of Allied Health, Murdoch University, 90 South Street, Murdoch, WA, 6150
Country 134891 0
Australia
Phone 134891 0
+61 8 9360 6000
Fax 134891 0
Email 134891 0
[email protected]
Contact person for scientific queries
Name 134892 0
Timothy Fairchild
Address 134892 0
School of Allied Health, Murdoch University, 90 South Street, Murdoch, WA, 6150
Country 134892 0
Australia
Phone 134892 0
+61 8 9360 2959
Fax 134892 0
Email 134892 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• researchers who provide a methodologically sound proposal;
case-by-case basis at the discretion of the investigator team


Conditions for requesting access:
• -

What individual participant data might be shared?
• Deidentified IPD underlying published results only

What types of analyses could be done with individual participant data?
• to achieve the aims in the approved proposal;
for IPD meta-analyses


When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• access subject to approvals by Principal Investigator
Title: A/Prof
Name: Timothy Fairchild
Address: School of Allied Health, Murdoch University, 90 South Street, Murdoch, WA, 6150
Country: Australia
Telephone number: +61 8 9360 2959
Email: [email protected]


Are there extra considerations when requesting access to 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.