Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615001256561
Ethics application status
Approved
Date submitted
6/11/2015
Date registered
17/11/2015
Date last updated
5/03/2018
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
Physiotherapy

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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
none
Timepoint [1] 318901 0
none

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Crossover
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
NO formal sample size calculation was performed

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/11/2016
Actual
28/11/2016
Date of last participant enrolment
Anticipated
Actual
6/02/2017
Date of last data collection
Anticipated
Actual
1/04/2017
Sample size
Target
12
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 292158 0
University
Name [1] 292158 0
Bond University
Country [1] 292158 0
Australia
Primary sponsor type
University
Name
Bond University
Address
2 Promethean Way
Robina, 4226 QLD
Country
Australia
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
Australia

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 293634 0
07/10/2016
Approval date [1] 293634 0
18/10/2016
Ethics approval number [1] 293634 0

Summary
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

Contacts
Principal investigator
Name 60546 0
Miss Whitney Mills
Address 60546 0
Organization: Bond University
14 University Drive
Robina, 4226, QLD
Country 60546 0
Australia
Phone 60546 0
+61468892278
Fax 60546 0
Email 60546 0
[email protected]
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
Australia
Phone 60547 0
+61 7 5595 1111
Fax 60547 0
Email 60547 0
[email protected]
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
Australia
Phone 60548 0
+61 7 5595 4155
Fax 60548 0
Email 60548 0
[email protected]

No information has been provided regarding IPD availability


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.