Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000802404
Ethics application status
Approved
Date submitted
11/05/2025
Date registered
28/07/2025
Date last updated
28/07/2025
Date data sharing statement initially provided
28/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of characteristics of autism spectrum disorder on the health of primary caregivers and the effects of exercise interventions on the health of children with autism spectrum disorder and their primary caregivers
Scientific title
The impact of characteristics of autism spectrum disorder on the health of primary caregivers and the effects of exercise interventions on the health of children with autism spectrum disorder and their primary caregivers
Secondary ID [1] 314423 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism 337438 0
Condition category
Condition code
Mental Health 333812 333812 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be aimed to evaluate the effects of three 3-month exercise interventions—inline skating, yoga, and taekwondo—on children with autism spectrum disorder (ASD) aged 6 to 10 years and their parents. Each intervention, conducted twice weekly for 80 minutes over 12 weeks, will be delivered in three formats: child-only intervention, parent-only intervention, and parent-child intervention.

Each year will focus on one type of exercise (Year 1: inline skating; Year 2: yoga; Year 3: taekwondo), with new participants recruited annually: 20 for each of the child-only and parent-only groups, and 20 parent-child dyads for the parent-child group.

Inline skating intervention
a) The inline skating training protocol that suits the participants’ motor abilities will be produced by a skilled inline skating instructor.
b) Schedule: The sessions will be delivered twice weekly over a continuous 12-week period during the 2025–2026 academic year.
c) Session Structure: Each session will last 80 minutes and will include 15 minutes of warm-up, 60 minutes of main activity training (divided into 40 minutes of motor skill training and 20 minutes of cardiovascular training), and 5 minutes of cool-down.
d) Program Dosage: The full intervention will consist of 24 sessions, totaling 32 hours of direct instruction.
e) The intervention will be taught by a national coach who previously coached the Taiwanese national inline skating team and a research assistant with expertise in inline skating. Both instructors will have prior experience working with children with ASD.
f) All sessions will be assisted and supervised by the primary researcher.
g) Each session will be concluded with an opportunity to play with children’s favorite activities as a reward.
h) All intervention sessions will be conducted in a gymnasium in a large and public urban university in South Taiwan.
i) The training activities will be of low to moderate intensity, based on the Borg RPE scale.
j) The intervention will be delivered in groups, each consisting of 20 participants.
k) Participants will be assigned to the delivery formats based on participant choice, and then randomly assigned to either experimental group or wait-list control group.
l) For each delivery format, the participants will stay in the delivery format.
m) Session attendance will be used to assess adherence to the interventions.
n) New participants will be recruited each year for each type of intervention.

Yoga intervention
a) Twelve structured yoga modules will be developed for this study based on the International Kids Yoga Alliance.
b) Schedule: The sessions will be delivered twice weekly over a continuous 12-week period during the 2026–2027 academic year.
c) Session Structure: The structured yoga modules followed a sequence of five components: (a) chanting (10 minutes), (b) preparatory practices (20 minutes), (c) yoga postures or asanas (20 minutes), breathing practices including breathing exercises and pranayama (20 minutes), and (e) relaxation (10 minutes).
d) Program Dosage: The full intervention will consist of 24 sessions, totaling 32 hours of direct instruction.
e) All sessions will be led by the yoga teacher who has relevant experience teaching children with disabilities.
f) All sessions will be supervised and assisted by the primary researcher.
g) Each session will be concluded with an opportunity to play with children’s favorite activities as a reward.
h) All intervention sessions will be conducted in a gymnasium in a large and public urban university in South Taiwan.
i) The training activities will be of low to moderate intensity, based on the Borg RPE scale.
j) The intervention will be delivered in groups, each consisting of 20 participants.
k) Participants will be assigned to the delivery formats based on participant choice, and then randomly assigned to either experimental group or wait-list control group.
l) For each delivery format, the participants will stay in the delivery format.
m) Session attendance will be used to assess adherence to the interventions.
n) New participants will be recruited each year for each type of intervention.

Taewondo intervetnion
a) The Taewondo training protocol that suits the participants’ motor abilities will be produced by a skilled Taewondo instructor.
b) Schedule: The sessions will be delivered twice weekly over a continuous 12-week period during the 2027–2028 academic year.
c) Session Structure: The intervention program will consist of 10 minutes of warm-up, 30 minutes of blocking, punching, and kicking, 30 minutes of Poomsae, and 10 minutes of cool-down.
d) Program Dosage: The full intervention will consist of 24 sessions, totaling 32 hours of direct instruction.
e) All sessions will be led by a qualified Taekwondo instructor who has relevant experience teaching children with disabilities.
f) All sessions will be supervised and assisted by the primary researcher.
g) Each session will be concluded with an opportunity to play with children’s favorite activities as a reward.
h) All intervention sessions will be conducted in a gymnasium in a large and public urban university in South Taiwan.
i) The training activities will be of low to moderate intensity, based on the Borg RPE scale.
j) The intervention will be delivered in groups, each consisting of 20 participants.
k) Participants will be assigned to the delivery formats based on participant choice, and then randomly assigned to either experimental group or wait-list control group.
l) For each delivery format, the participants will stay in the delivery format.
m) Session attendance will be used to assess adherence to the interventions.
n) New participants will be recruited each year for each type of intervention.
Intervention code [1] 331030 0
Behaviour
Intervention code [2] 331275 0
Treatment: Other
Comparator / control treatment
wait-list control group (Participants will be paired based on age, medication status, and ASD presentation and then randomly assigned to either an intervention group or a wait-list control group). The control group will be offered the intervention 3 months after the intervention has been completed each year.
Control group
Active

Outcomes
Primary outcome [1] 341413 0
Cognitive outcome: Change in Stroop color-word score
Timepoint [1] 341413 0
Each participant will be assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3) (primary endpoint).
Primary outcome [2] 341414 0
Psychosocial outcome: Change in Sleep Quality score
Timepoint [2] 341414 0
Each participant will be assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3) (primary endpoint).
Primary outcome [3] 341415 0
Physical outcome: Change in health-related Physical fitness score
Timepoint [3] 341415 0
Each participant will be assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3) (primary endpoint).
Secondary outcome [1] 447442 0
Psychological outcome (i.e., World Health Organization Quality of Life Scale)
Timepoint [1] 447442 0
Each participant will be assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3).
Secondary outcome [2] 448737 0
Psychological outcome (i.e., Parenting Stress Index-4-Short Form). This is a primary outcome.
Timepoint [2] 448737 0
Each participant will be assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3) (primary endpoint).
Secondary outcome [3] 448738 0
Physical outcomes (i.e., Physical Activity [ActiGraph, wGT3X-BT]). This is a primary outcome.
Timepoint [3] 448738 0
Each participant will be assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3) (primary endpoint).
Secondary outcome [4] 448739 0
Psychosocial outcomes (i.e., SAdaptive Behavior Assessment System-2)
Timepoint [4] 448739 0
Each participant will be assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3) (primary endpoint).
Secondary outcome [5] 448740 0
Cognitive outcomes (i.e., Spatial Working Memory). This is a primary outcome.
Timepoint [5] 448740 0
Each participant will be assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3) (primary endpoint).
Secondary outcome [6] 448741 0
Cognitive outcomes (i.e., Stockings of Cambridge). This is a primary outcome.
Timepoint [6] 448741 0
Each participant will be assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3) (primary endpoint).
Secondary outcome [7] 448742 0
Cognitive outcomes (i.e., Wisconsin Card Sorting Test). This is a primary outcome.
Timepoint [7] 448742 0
Each participant will be assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3) (primary endpoint).

Eligibility
Key inclusion criteria
The inclusion criteria for the participants with ASD will be as follows: (1) current age between 6 and 10 years, (2) a diagnosis of ASD based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, text revision (DSM-V-TR), and (3) having no additional disabilities or diseases that may interfere with the exercise intervention program, cognitive assessments, physical or psychological evaluations.

The inclusion criteria for the parents of participants with ASD will be as follows: (1) must be the primary caregiver of a child with ASD, and (2) must participate voluntarily, have no communication difficulties, and have no disabilities or diseases that may interfere with the exercise intervention program, physical assessments, or psychological evaluations.
Minimum age
6 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children diagnosed with intellectual disability and cerebral palsy will be excluded.

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 concealed by numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using coin-tossing
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2027
Actual
Date of last data collection
Anticipated
31/07/2028
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 27057 0
Taiwan, Province Of China
State/province [1] 27057 0

Funding & Sponsors
Funding source category [1] 318949 0
Government body
Name [1] 318949 0
National Science and Technology Council
Country [1] 318949 0
Taiwan, Province Of China
Primary sponsor type
Government body
Name
National Science and Technology Council
Address
Country
Taiwan, Province Of China
Secondary sponsor category [1] 321418 0
University
Name [1] 321418 0
National Kaohsiung Normal University
Address [1] 321418 0
Country [1] 321418 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317557 0
National Cheng Kung University Human Research Ethics Committee
Ethics committee address [1] 317557 0
Ethics committee country [1] 317557 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 317557 0
06/02/2025
Approval date [1] 317557 0
15/04/2025
Ethics approval number [1] 317557 0
NCKU HREC-F-114-0067-2

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

Contacts
Principal investigator
Name 141430 0
Prof Chien-Yu Pan
Address 141430 0
National Kaohsiung Normal University. No.116, Heping 1st Rd., Lingya District, Kaohsiung City 802561, Taiwan, R.O.C.
Country 141430 0
Taiwan, Province Of China
Phone 141430 0
+88677172930
Fax 141430 0
Email 141430 0
[email protected]
Contact person for public queries
Name 141431 0
Chien-Yu Pan
Address 141431 0
National Kaohsiung Normal University. No.116, Heping 1st Rd., Lingya District, Kaohsiung City 802561, Taiwan, R.O.C.
Country 141431 0
Taiwan, Province Of China
Phone 141431 0
+88677172930
Fax 141431 0
Email 141431 0
[email protected]
Contact person for scientific queries
Name 141432 0
Chien-Yu Pan
Address 141432 0
National Kaohsiung Normal University. No.116, Heping 1st Rd., Lingya District, Kaohsiung City 802561, Taiwan, R.O.C.
Country 141432 0
Taiwan, Province Of China
Phone 141432 0
+88677172930
Fax 141432 0
Email 141432 0
[email protected]

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


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    114-0067??????.pdf


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.