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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Does hydrotherapy influence behaviours in children with autism spectrum disorder (ASD)?
Scientific title
Does hydrotherapy influence behaviours in children with autism spectrum disorder (ASD)?
Secondary ID [1] 287526 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 296291 0
Condition category
Condition code
Neurological 296577 296577 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 296578 296578 0 0

Study type
Description of intervention(s) / exposure
Hydrotherapy, which includes therapeutic exercises held in a warm pool for a relaxing effect, provided by physiotherapists. Each session will last approximately 45 minutes. The number of children in the water at a time will be no more than 4 children. Sessions will run 1-2 times weekly. This treatment intervention will be provided in addition to the children's current educational and therapy programs. Group 1 will complete 4 weeks of hydrotherapy while group 2 continues with their current programs. After 4 weeks, group 1 and 2 will switch, allowing group 2 to complete hydrotherapy and group 1 to return to their current programs without the addition of hydrotherapy.
Intervention code [1] 292931 0
Treatment: Other
Comparator / control treatment
Participants will continue their usual individual routines which may include physical activity and adjunct therapy. Pharmacological therapy may also be included, depending on the child's needs.
Control group

Primary outcome [1] 296193 0
Child Behaviour Checklist 6-18 (CBCL 6-18) is a 113 item questionnaire that will be completed by the parents at week 0, 4 and 8. The questionnaire should take approximately 15-20 minutes to complete. It is used to detect behavioural and emotional problems in children and adolescence. The CBCL 6-18 covers children 6 to 18 years of age. This questionnaire covers many different areas: anxiety/depression, somatic complaints, social issues, thought and attention difficulties, rule-breaking and aggressive behaviour, ADHD, oppositional defiant problems and conduct difficulties.
Timepoint [1] 296193 0
All parents/guardians will be required to complete the Child Behaviour Checklist (CBCL) at week 0, 4 and 8.
Secondary outcome [1] 318901 0
Timepoint [1] 318901 0

Key inclusion criteria
The inclusion criteria for participants includes:
a) a patient at Gateway Physiotherapy (Private Practice, Brisbane) or at a local GP clinic
b) aged 6-12 years of age
c) a diagnosis of Autism Spectrum Disorder
Minimum age
6 Years
Maximum age
12 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
The exclusion criteria for participants includes:
a) patients with contraindications to hydrotherapy
b) if the patient has a fear of water

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A concealed randomized allocation procedure will assign each participant to either Group 1 or Group 2. Parent of participant will select a sealed envelope allocating them to a group.
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
Other design features
Type of endpoint(s)
Statistical methods / analysis
NO formal sample size calculation was performed

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 292158 0
Name [1] 292158 0
Bond University
Address [1] 292158 0
2 Promethean Way
Robina, 4226, QLD
Country [1] 292158 0
Primary sponsor type
Bond University
2 Promethean Way
Robina, 4226 QLD
Secondary sponsor category [1] 290834 0
Commercial sector/Industry
Name [1] 290834 0
Gateway Physiotherapy
Address [1] 290834 0
17/590 Mt Gravatt Capalaba Rd
Wishart, QLD 4122
Country [1] 290834 0

Ethics approval
Ethics application status
Ethics committee name [1] 293634 0
Bond University’s Human Research Ethics Committee (BUHREC)
Ethics committee address [1] 293634 0
14 University Drive
Robina, 4226, QLD
Ethics committee country [1] 293634 0
Date submitted for ethics approval [1] 293634 0
Approval date [1] 293634 0
Ethics approval number [1] 293634 0

Brief summary
After providing consent, if no contraindications to hydrotherapy are identified in the pre-study screening assessment, the child will be included in the study. A concealed randomized allocation procedure will assign each participant to either Group 1 or Group 2 (parent will select a sealed envelope allocating the child to a group). The duration of this study is 9 weeks. Group 1 will be asked to participate in a 45-min hydrotherapy class, 1x weekly for 4 weeks. Group 2; will receive no hydrotherapy intervention. At the end of 4 weeks, Group 1 will cease hydrotherapy, and Group 2 will commence hydrotherapy sessions. Hydrotherapy sessions will involve gentle therapeutic exercise in a warm, temperature controlled pool under the supervision of members of the research team. All parents/guardians will be required to complete the Child Behaviour Checklist (CBCL) at weeks 0, 4 and 8. The CBCL is a short and meaningful questionnaire that assesses a range of concepts associated with children's behaviours. The CBCL, which has been validated for use with children with ASD, will determine any behavioural changes of participants during the study. To limit the bias from the researchers conducting the intervention, parents/guardians will be asked to place their completed questionnaires into an envelope which will be sealed by the participant and returned to a third investigator who will not be in contact with the participants or their parents. The Enjoyment Scale is a visual scale in which the participants can express their willingness participant in the hydrotherapy activities throughout the study. The Enjoyment Scale will be used at the end of each hydrotherapy session to monitor level of enjoyment and willingness to continue with hydrotherapy sessions.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 60546 0
Miss Whitney Mills
Address 60546 0
Organization: Bond University
14 University Drive
Robina, 4226, QLD
Country 60546 0
Phone 60546 0
Fax 60546 0
Email 60546 0
Contact person for public queries
Name 60547 0
Dr Rob Orr
Address 60547 0
Organization: Bond University Institute of Health and Sport
2 Promethean Way
Robina, 4226, QLD
Country 60547 0
Phone 60547 0
+61 7 5595 1111
Fax 60547 0
Email 60547 0
Contact person for scientific queries
Name 60548 0
Dr Nikki Milne
Address 60548 0
Organization: Bond University Institute of Health and Sport
2 Promethean Way
Robina, 4226, QLD
Country 60548 0
Phone 60548 0
+61 7 5595 4155
Fax 60548 0
Email 60548 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary