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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
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Scientific title
Mapping physical activities to goals for children with autism: codesigned program feasibility and efficacy
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Secondary ID [1]
312327
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Spinnaker Health Research Foundation/Telethon 2023 Grant (REF #2024-EF-RETRO-001-83100-SHRF)
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Universal Trial Number (UTN)
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Trial acronym
ExAut
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
autistic spectrum disorders
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physical inactivity
334086
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Condition category
Condition code
Mental Health
330763
330763
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0
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Autistic spectrum disorders
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Physical Medicine / Rehabilitation
330764
330764
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328807
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Treatment: Other
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Intervention code [2]
328808
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Lifestyle
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Intervention code [3]
328809
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Behaviour
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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physical activity engagement
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Assessment method [1]
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actigraphy (quantitative)
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Timepoint [1]
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week 0, week 4 (midpoint), week 8
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Primary outcome [2]
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self-reported health
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Assessment method [2]
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Child Health Questionnaire - Short Form (CHQ-S)
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Timepoint [2]
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week 0, week 4 (midpoint), week 8
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Primary outcome [3]
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Preferences for physical activity type
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Assessment method [3]
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Semi-structured one-on-one, face-to-face interview with a member of the research team.
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Timepoint [3]
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week 0, week 8
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Secondary outcome [1]
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cardiorespiratory fitness
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Assessment method [1]
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maximal oxygen consumption test (metabolic cart) and electromagnetically braked cycle ergometer
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Timepoint [1]
436263
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week 0, week 4 (midpoint), week 8
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Secondary outcome [2]
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muscular strength
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Assessment method [2]
436264
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Composite score of 3-repetition maximum on bench press exercise (chest) and leg-press exercise.
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Timepoint [2]
436264
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week 0, week 4 (midpoint), week 8
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Secondary outcome [3]
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sleep quantity
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Assessment method [3]
436267
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wrist worn actigraphy with sleep diary
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Timepoint [3]
436267
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week 0, week 4 (midpoint), week 8
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Secondary outcome [4]
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social communication
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Assessment method [4]
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Social Communication Questionnaire (SCQ)
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Timepoint [4]
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week 0, week 8
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Secondary outcome [5]
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cognitive capabilities
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Assessment method [5]
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Weschler Abbreviated Scale of Intelligence (WASI-II)
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Timepoint [5]
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week 0, week 8
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Secondary outcome [6]
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receptive vocabulary
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Assessment method [6]
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Peabody Picture Vocabulary Test 5 (PPVT-5)
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Timepoint [6]
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week 0, week 8
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Secondary outcome [7]
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Sleep quality
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Assessment method [7]
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Childhood Sleep Habits Questionnaire (CSHQ)
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Timepoint [7]
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week 0, week 4 (midpoint), week 8
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Secondary outcome [8]
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Preferences for physical function assessments
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Assessment method [8]
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Semi-structured one-on-one, face-to-face interview with a member of the research team.
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Timepoint [8]
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week 0, week 8
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Eligibility
Key inclusion criteria
Diagnosis: autism spectrum disorder (ASD)
Geographic location: Perth metropolitan area
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Minimum age
5
Years
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Maximum age
12
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
unable to communicate effectively, unable to participate in physical activity, unable to attend intervention sessions
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/07/2024
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Actual
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Date of last participant enrolment
Anticipated
20/12/2024
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Channel 7 Telethon Trust
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Address [1]
316724
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Country [1]
316724
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Spinnaker Health Research Foundation
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Address
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Country
Australia
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Secondary sponsor category [1]
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Charities/Societies/Foundations
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Name [1]
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The Hospital Research Foundation Group
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Address [1]
318929
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Country [1]
318929
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Australia
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Secondary sponsor category [2]
318930
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Charities/Societies/Foundations
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Name [2]
318930
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Murdoch University
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Address [2]
318930
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Country [2]
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Australia
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Other collaborator category [1]
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Individual
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Name [1]
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Dr Ben Jackson
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Address [1]
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Country [1]
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Australia
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Other collaborator category [2]
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Individual
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Name [2]
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Stephanie Dowden
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Address [2]
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Country [2]
283086
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Australia
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Other collaborator category [3]
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Individual
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Name [3]
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Dr Janine Spencer
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Address [3]
283092
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Country [3]
283092
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Australia
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Other collaborator category [4]
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Individual
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Name [4]
283093
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Wendy McCafferty
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Address [4]
283093
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Country [4]
283093
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Australia
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Other collaborator category [5]
283094
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Individual
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Name [5]
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Dr Shailander Mehta
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Address [5]
283094
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Country [5]
283094
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Australia
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Other collaborator category [6]
283095
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Individual
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Name [6]
283095
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Dr Brook Galna
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Address [6]
283095
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Country [6]
283095
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Australia
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Other collaborator category [7]
283096
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Individual
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Name [7]
283096
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Dr Shu Yau
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Address [7]
283096
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Country [7]
283096
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Murdoch University Human Research Ethics Committee
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Ethics committee address [1]
315499
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http://our.murdoch.edu.au/Research-Ethics-and-Integrity/Human-research-ethics
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Ethics committee country [1]
315499
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Australia
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Date submitted for ethics approval [1]
315499
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29/02/2024
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Approval date [1]
315499
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17/05/2024
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Ethics approval number [1]
315499
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2024/046
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Summary
Brief summary
Physical activity (PA) improves motor skills, fitness, social functioning, muscular strength, and endurance in children with autism. However, the benefits of PA depend on the type of PA. In this study, we will co-design a PA program with parents and children to tailor benefits of PA to individual goals and determine the impact the PA has on everyday life. We expect to find that parents and children share some common goals for PA; that fun-based individual activities will be preferred PA; and that positive physical and mental health outcomes will result from adherence to the PA program.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Timothy Fairchild
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Address
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School of Allied Health, Murdoch University, 90 South Street, Murdoch, WA, 6150
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Country
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Australia
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Phone
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+61 8 9360 2959
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Stephanie Bovell
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Address
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School of Allied Health, Murdoch University, 90 South Street, Murdoch, WA, 6150
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Country
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Australia
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Phone
134891
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+61 8 9360 6000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
134892
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Timothy Fairchild
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Address
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School of Allied Health, Murdoch University, 90 South Street, Murdoch, WA, 6150
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Country
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Australia
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Phone
134892
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+61 8 9360 2959
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Fax
134892
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Email
134892
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Deidentified IPD underlying published results only
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When will data be available (start and end dates)?
Immediately following publication, no end date
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Available to whom?
researchers who provide a methodologically sound proposal;
case-by-case basis at the discretion of the investigator team
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Available for what types of analyses?
to achieve the aims in the approved proposal;
for IPD meta-analyses
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How or where can data be obtained?
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]
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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.
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