Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12622001168741
Ethics application status
Approved
Date submitted
22/08/2022
Date registered
26/08/2022
Date last updated
26/08/2022
Date data sharing statement initially provided
26/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Family Surfing Activity for children and adolescents with chronic conditions: Effects on Health and Well-being
Scientific title
Family Surfing Activity for children and adolescents with chronic conditions: Effects on Health and Well-being
Secondary ID [1] 307798 0
None
Universal Trial Number (UTN)
U1111-1281-8351
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 327401 0
Type I Diabetes 327402 0
Sarcoma 327403 0
Juvenile Idiopathic Arthritis 327404 0
Post Burn Injury 327405 0
Cerebral Palsy 327406 0
Condition category
Condition code
Cancer 324530 324530 0 0
Bone
Metabolic and Endocrine 324532 324532 0 0
Diabetes
Injuries and Accidents 324533 324533 0 0
Burns
Human Genetics and Inherited Disorders 324534 324534 0 0
Cystic fibrosis
Musculoskeletal 324535 324535 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 324536 324536 0 0
Rheumatoid arthritis
Neurological 324566 324566 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be a randomised, controlled, parallel, group study. Participants will be recruited and then allocated in a 2:1 ratio to the surfing intervention (experimental group) or into a control group. The surfing intervention will consist of 12 x 1 hour surfing lessons with the patient and family administered over an 8 week period. This will be conducted by one surf school and the family will be allocated the same instructor for the duration of the 12 lessons. Attendance will be recorded on a secure booking database. To evaluate the intervention, participants (regardless of group assignment) will complete questionnaires pre and post intervention, and after 12 weeks’ follow up. Qualitative data will be collected from a randomised subset of 40 families from the intervention group about their surfing experience. This will be conducted by a researcher on the team via semi-structured interview.
Our participants will be recruited from the following patient groups:
• Cystic Fibrosis (CF)
• Juvenile Idiopathic Arthritis (JIA)
• Post Burns Injury (PBI)
• Cerebral Palsy (CP)
• Type I Diabetes (T1D)
• Oncology disease (sarcoma)
• (Autism - in the future, we do not have funding for this group yet)
• (Mental Health Disorder: inpatients - in the future, no funding for this group yet)

We aim to recruit 20 individuals and their families from each pathology subgroup for the surfing intervention, which will result in a total of 120 patients and their families in the experimental arm of the study.

The surfing lessons are designed specifically for this study and each participant will have their lesson plan modified based on their ability and the information provided from and assessed by the physiotherapist on the research team, with the Goal Attainment Scale.
Surfing Intervention
Participant family arrives at surf school location in Perth area.
Surf instructor builds rapport with family members, and reviews skills and abilities.
Surfboards and wetsuits are provided to all participants.
Patient and other participants wear white rash vest.
Surf instructor takes participant family to beach and picks surf spot.
Surf instructor provides education on safety, positioning on surfboard, paddling, catching waves, take-off (standing up on surfboard).
Surf instructor provides instruction, evaluation and modelling of surf skills during lesson.
At the end of the lesson the surf instructors takes participant families back to the van.

Each surf lesson is 1 hour in duration
Surf instructor will focus on building a positive relationship with participants over the lessons
Intervention code [1] 324282 0
Treatment: Other
Comparator / control treatment
The control group will also include individuals and their families from the above pathology subgroups. For the control group we will recruit 10 patients and their families into each subgroup (60 in total), They will complete the same questionnaires as the intervention group at the 3 time points but will not take part in the surfing intervention.
Control group
Active

Outcomes
Primary outcome [1] 332359 0
Change in psychological wellbeing measured by the Strengths and Difficulties Questionnaire (SDQ).
Timepoint [1] 332359 0
The SDQ will be administered at
Timepoint 1 (before intervention)
Timepoint 2 (post-completion of intervention: end of week 8 lesson)
3 month follow up (post-completion of intervention)
Control group will complete at same timepoints
Primary outcome [2] 332399 0
Change in experience with surfing as measured by the Goal Attainment Scale (GAS) and qualitative information from the semi-structured interviews
Timepoint [2] 332399 0
Timepoint 1 - before intervention (GAS)
Timepoint 2 post-intervention (GAS and semi structured interviews)
Primary outcome [3] 332403 0
Change in psychological wellbeing and quality of life as measured by the PedsQL
Timepoint [3] 332403 0
Timepoint 1: before the intervention
Timepoint 2: post-completion of the intervention
Timepoint 3: 3 months after completion of the intervention

The control group will complete the same measure at the same timepoints
Secondary outcome [1] 413188 0
Change in parenting stress as measured by the Parenting Stress Scale
Timepoint [1] 413188 0
Parenting Stress Scale administered to primary caregiver at
Timepoint 1 Before intervention
Timepoint 2 (post-completion of intervention)
Timepoint 3 3 months post-completion of intervention)
Control group will be administered questionnaires at same timepoints

Eligibility
Key inclusion criteria
Participant inclusion criteria.

• Participants will include patients with CF, JIA, PBI, CP, oncology disease, T1D aged 7-18 years and their family members. Caregivers and siblings of patients will be aged 7 years or older. A maximum of 5 family members, including the patient, will be allowed.
• Patients and family members who participate in the surfing intervention will need to have the ability to swim safely in ocean water.
Minimum age
7 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participant exclusion criteria.

The following will be excluded from participation:
• Individuals with pre-existing comorbidities that preclude participation in surfing.
• Individuals from the surfing intervention who are unable to float or tread water briefly.
• Women who are pregnant (caregiver)
• Individuals with a moderate intellectual disability

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)
Method of allocation concealment was by generating a randomisation table using Sealed Envelope computer software program and allocation was completed by separate project manager who had access to this table.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation table generated by computer software program called "Sealed Envelope"
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome is the Strengths and Difficulties Questionnaire (SDQ). A total of 180 children and adolescents will be recruited with a 2:1 allocation to intervention and control groups. It is not possible with existing evidence to provide a sample size calculation for the mixed-effects model in the primary analysis. Therefore, to estimate the power of the study we have assumed independent analyses within each chronic condition to compare the intervention group (n=20) with a combined control group (n=60). This provides at least 80% power to detect a difference of 4 SDQ-units in the post-intervention SDQ score using a two-sided test, a significance level of 5% and assuming a standard deviation of 5 SDQ-units.

The analysis of the primary outcome will be a linear mixed-effects model with fixed effects for pre-intervention score (baseline) and intervention, random effects for child nested within pathology subgroup and a compound symmetry correlation structure. Secondary outcomes will be analysed similarly and sensitivity analyses will be performed to explore potential differential intervention effects across the pathology subgroups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/08/2022
Date of last participant enrolment
Anticipated
1/01/2025
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
180
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23015 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 38330 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 312067 0
Charities/Societies/Foundations
Name [1] 312067 0
Perth Children's Hospital Foundation
Country [1] 312067 0
Australia
Funding source category [2] 312098 0
Charities/Societies/Foundations
Name [2] 312098 0
Stan Perron Charitable Foundation
Country [2] 312098 0
Australia
Primary sponsor type
Hospital
Name
Perth Children's Hospital
Address
15 Hospital avenue
Nedlands 6009
Western Australia
Country
Australia
Secondary sponsor category [1] 313573 0
None
Name [1] 313573 0
Address [1] 313573 0
Country [1] 313573 0
Other collaborator category [1] 282413 0
University
Name [1] 282413 0
University of Western Australia
Address [1] 282413 0
35 Stirling Hwy
Crawley 6009
Western Australia
Country [1] 282413 0
Australia
Other collaborator category [2] 282414 0
Other
Name [2] 282414 0
Telethon Kids Institute - research institute
Address [2] 282414 0
15 Hospital avenue
Nedlands 6009
Western Australia
Country [2] 282414 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311477 0
Child and Adolescent Health Service Ethics Committee
Ethics committee address [1] 311477 0
Ethics committee country [1] 311477 0
Australia
Date submitted for ethics approval [1] 311477 0
20/04/2021
Approval date [1] 311477 0
28/02/2022
Ethics approval number [1] 311477 0
RGS 0000003664

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

Contacts
Principal investigator
Name 121234 0
Ms Joanna White
Address 121234 0
Perth Children's Hospital
15 Hospital avenue
Nedlands 6009
Western Australia
Country 121234 0
Australia
Phone 121234 0
+61 8 64564917
Fax 121234 0
Email 121234 0
[email protected]
Contact person for public queries
Name 121235 0
Joanna White
Address 121235 0
Perth Children's Hospital
15 Hospital avenue
Nedlands 6009
Western Australia
Country 121235 0
Australia
Phone 121235 0
+61 8 6456 4917
Fax 121235 0
Email 121235 0
[email protected]
Contact person for scientific queries
Name 121236 0
Andre Schultz
Address 121236 0
Perth Children's Hospital
15 Hospital avenue
Nedlands 6009
Western Australia
Country 121236 0
Australia
Phone 121236 0
+61 8 64562222
Fax 121236 0
Email 121236 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified individual participant data of published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Researchers who provide a methodologically sounds proposal and have obtained appropriate ethical and governance approvals
Available for what types of analyses?
IPD meta-analyses
How or where can data be obtained?
Access is subject to approval by the Principal Investigator
Joanna White
Perth Children's Hospital
+618 6456 4917
[email protected]


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.