Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000579190
Ethics application status
Approved
Date submitted
5/04/2019
Date registered
15/04/2019
Date last updated
15/04/2019
Date data sharing statement initially provided
15/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Surfing for youth mental health: A randomised wait-list controlled trial
Scientific title
Effects of surf therapy on indicators of youth mental health: A randomised wait-list controlled trial
Secondary ID [1] 297618 0
NIl
Universal Trial Number (UTN)
U1111-1229-5991
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 311891 0
Anxiety 311892 0
Behavioural problems (conduct, hyperactivity) 312275 0
Condition category
Condition code
Mental Health 310479 310479 0 0
Anxiety
Mental Health 310480 310480 0 0
Depression
Mental Health 310824 310824 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a 6-week mentor-lead surf therapy program, provided to youth who have been referred due to vulnerabilities to a range of mental health problems. Children participating in the intervention will attend one 2-hour surf therapy session, every weekend for six consecutive weekends. Children are provided with required surf material (surfboard and wetsuit). Prior to intervention commencement, children are matched to a surf-mentor based on their referring presentation and the surf-mentors experience and characteristics.

Children will receive one-on-one surf instruction and mentorship throughout the program with the same mentor while learning to surf alongside a small group of 10-12 children. On a backdrop of learning to surf, the focus of this mentorship is to help children develop a secure relationship with their mentor and a sense of belonging and connectedness to the group, while also learning social skills, teamwork, perseverance in the face of challenge, psychological flexibility, and self-regulation. This is achieved through upholding the identified values laid out by Ocean Mind at the outset of the program and ongoing conversation between child and surf-mentor, as well as social support provided by the larger group. It is hypothesized that the mentor-child relationship and surf group setting will provide the appropriate context to develop these skills, which in turn will lead to improvements in symptoms of anxiety and depression and behavioural conduct problems, as well as social connectedness, self-confidence and community engagement.

Adherence to the intervention will be monitored via program attendance log and surf mentor weekly logs.

The pace and goals of the program are participant led and individualised to each young person, and depend on the surf skills of the child and referring presentation. Throughout the intervention participants can choose to work 1:1 with their mentor, or they can become more involved with the wider group. Mentors are trained volunteers from the community who are experienced surfers and with high water competency and knowledge of the ocean.

The intervention will take place in the Geelong/Surf Coast region of Victoria, Australia.
Intervention code [1] 313859 0
Prevention
Intervention code [2] 313860 0
Lifestyle
Intervention code [3] 313861 0
Behaviour
Comparator / control treatment
The intervention group will be evaluated against a wait-list control group, comprising children who have been referred to Ocean Mind by a professional (e.g. psychologist, school counsellor) due to identified vulnerabilities to a mental health problem. The control group will be offered the intervention after the final study assessment (e.g. 12-weeks post baseline).
Control group
Active

Outcomes
Primary outcome [1] 319346 0
Change in Revised Children’s Anxiety and Depression Scale–Short version - Anxiety scale
Timepoint [1] 319346 0
Baseline, 6 weeks (primary time point), 8 weeks and 12 weeks
Primary outcome [2] 319348 0
Change in Revised Children’s Anxiety and Depression Scale–Short version - Depression scale
Timepoint [2] 319348 0
Baseline, 6 weeks (primary time point), 8 weeks and 12 weeks
Primary outcome [3] 319351 0
Change in Strengths and Difficulties Questionnaire Internalising and Externalising symptom subscales
Timepoint [3] 319351 0
Baseline, 6 weeks, 8 weeks and 12 weeks
Secondary outcome [1] 367848 0
Change in Self-Description Questionnaire Short-Form (Global and Physical Abilities subscales)
Timepoint [1] 367848 0
Baseline, 6 weeks (secondary timepoint), 8 weeks and 12 weeks
Secondary outcome [2] 367849 0
Change in the Connectedness to Nature Short Inventory
Timepoint [2] 367849 0
Baseline, 6 weeks, 8 weeks and 12 weeks
Secondary outcome [3] 367850 0
Social Climate and Social Identification assessed with an adapted version of the School Climate and Social Identity measure
Timepoint [3] 367850 0
6 weeks, 8 weeks and 12 weeks
Secondary outcome [4] 367851 0
Emotion regulation, integration with family, linkages to the community, goal setting, problem-solving and time management assessed via the Youth Experiences Survey (YES) 2.0
Timepoint [4] 367851 0
6 weeks , 8 weeks and 12 weeks
Secondary outcome [5] 369080 0
Social support assessed via the Multidimensional Scale of Perceived Social Support.
Timepoint [5] 369080 0
6 weeks, 8 weeks and 12 weeks

Eligibility
Key inclusion criteria
Age 8 to 18 years
Referred by a professional in the community (e.g. psychologist, school counsellor)
Ability to communicate in English
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment was maintained as the researcher who determines if a participant is eligible for inclusion in the trial will be unaware at the time of this decision, to which group the participant will be allocated, due to central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be undertaken using a computer generated randomisation table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
General linear mixed modelling will be used to quantify and assess the effects of the intervention on the differences between pre and post measures of our primary and secondary outcome variables. Other concomitant variables such as SES, age and gender will be considered and assessed as possible confounders of group effects.

Given likely 10% improvement in Intervention on primary outcome (SDQ externalising symptoms) from prior studies, 64 participants per group required, 5% significance level and 80% power.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2019
Actual
Date of last participant enrolment
Anticipated
24/04/2021
Actual
Date of last data collection
Anticipated
17/07/2021
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 25906 0
3228 - Torquay
Recruitment postcode(s) [2] 25907 0
3220 - Geelong
Recruitment postcode(s) [3] 25908 0
3226 - Ocean Grove
Recruitment postcode(s) [4] 25909 0
3227 - Breamlea
Recruitment postcode(s) [5] 25910 0
3227 - Barwon Heads
Recruitment postcode(s) [6] 25911 0
3227 - Connewarre
Recruitment postcode(s) [7] 25912 0
3221 - Geelong
Recruitment postcode(s) [8] 25913 0
3223 - Bellarine
Recruitment postcode(s) [9] 25914 0
3224 - Leopold

Funding & Sponsors
Funding source category [1] 302161 0
University
Name [1] 302161 0
Deakin University
Country [1] 302161 0
Australia
Funding source category [2] 302164 0
Other Collaborative groups
Name [2] 302164 0
Ocean Mind
Country [2] 302164 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University Burwood Campus
221 Burwood Highway
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 302004 0
None
Name [1] 302004 0
Address [1] 302004 0
Country [1] 302004 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302842 0
Deakin University Human research Ethics Committee
Ethics committee address [1] 302842 0
Ethics committee country [1] 302842 0
Australia
Date submitted for ethics approval [1] 302842 0
18/01/2019
Approval date [1] 302842 0
12/03/2019
Ethics approval number [1] 302842 0
2019-016

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

Contacts
Principal investigator
Name 91578 0
Dr Lisa Olive
Address 91578 0
Deakin University Burwood Campus
221 Burwood Highway
Burwood VIC 3125
Country 91578 0
Australia
Phone 91578 0
+61 3 9246 8553
Fax 91578 0
Email 91578 0
[email protected]
Contact person for public queries
Name 91579 0
Lisa Olive
Address 91579 0
Deakin University Burwood Campus
221 Burwood Highway
Burwood VIC 3125
Country 91579 0
Australia
Phone 91579 0
+61 3 9246 8553
Fax 91579 0
Email 91579 0
[email protected]
Contact person for scientific queries
Name 91580 0
Lisa Olive
Address 91580 0
Deakin University Burwood Campus
221 Burwood Highway
Burwood VIC 3125
Country 91580 0
Australia
Phone 91580 0
+61 3 9246 8553
Fax 91580 0
Email 91580 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Results will be analysed at the treatment group data level, and any results from this trial that are published in scientific journals will publish group data only. As the youth that will participate in the study will be enrolled in the Ocean Mind program, data they provide may be potentially identifiable. To ensure anonymity and privacy, individual data will not be available or disseminated.


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.