Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000576426
Ethics application status
Approved
Date submitted
29/04/2016
Date registered
4/05/2016
Date last updated
10/12/2018
Date data sharing statement initially provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The development and implementation of Fit for Play, A program designed to develop the physical literacy and physical activity levels of children with a mental health disorder
Scientific title
The development, implementation and evaluation of FIT for PLAY: A Fundamental Integrative Training program, for Physically Literate and Active Youth with a mental health disorder
Secondary ID [1] 289110 0
Nil
Universal Trial Number (UTN)
Trial acronym
Fit for Play
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health Disorders 298573 0
Anxiety disorders 298574 0
Attention Deficit Hyperactivity Disorder 298575 0
Conduct Disorder
 298578 0
Condition category
Condition code
Mental Health 298653 298653 0 0
Anxiety
Mental Health 298655 298655 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participating children will complete a 10-week exercise program, Fit for Play. The program will include 2x45 minute small group sessions per week (n=6). Sessions will include a 10-minute warm-up of dynamic stretches and a fun game; followed by 25 minutes of activities designed to develop participants strength, aerobic fitness and fundamental movement skills. Aerobic activities will be moderate to high intensity (minimum 12 RPE). A 10-15-minute game-play activity e.g. modified basketball, soccer etc. will also be completed. This will be used to apply the skills developed throughout the session, as well as rule following and team work skills. Finally a 5 minute cool down of stretching will be performed. Education around physical activity, and its importance will be woven into each session to assist children to have a sound knowledge of physical activity upon program completion. These sessions will be completed at the Pathways centre, Shenton Park, under the supervision of an Accredited Exercise Physiologist.

Participants will also participate in one 30 minute exercise challenge each week, comprising of aerobic, strength, and fundamental movement skill development activities. The physical challenge will be prescribed by the research team (including exercise physiologists and occupational therapists, specialising in paediatrics), designed specifically to target individuals physical activity based goals. Participants will be encouraged to complete it in their own time, using any facilities available to them with the help of a parent/guardian. The purpose of this challenge is to encourage self-motivation to participate in physical activity.

Fit for Play will be implemented into a pre-existing 10-week therapeutic day program (Pathways) for children with severe internalising and externalising behaviours. Children attend the therapeutic day program twice a week. Fit for Play will be implemented into the Pathways timetable so will be completed twice a week for the duration of the 10-week program. Attendance at the Pathways program twice a week for 10-weeks is compulsory, therefore it is anticipated that unless children are unable to attend Pathways due to illness or otherwise, there will be no problems with program adherence.
Intervention code [1] 294613 0
Lifestyle
Comparator / control treatment
There will be no Control group included in this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298148 0
The primary outcome of this research is to determine the feasibility of implementing Fit for Play via completion of a process evaluation. The below parameters will be utilised to determine feasibility:
1. Fidelity – To what extent was the program delivered as planned? Was it feasible to deliver the intervention as planned? Assessed via interviews with Pathways staff, and session notes completed at the end of each session comparing what was planned for that session, and what was actually completed.
2. Dose Delivered – Were all the intervention components delivered? Assessed via session notes completed at the end of each session comparing what was planned for that session, and what was actually completed.
3. Dose Received– How receptive were the participants towards the intervention? To what extent did their behaviours change? Was Fit for Play enjoyed by participating children? Assessed via semi-structured interviews with participating children, parents/guardians and staff; and review of participant diary’s - Children will be asked to log the number of days they completed the at home exercises each week and how long they spent completing these exercises
4. Reach – Number of potential participants who agreed to participate; participant demographic information; recruitment methods and barriers. This will be determined from participant records, and semi-structured interviews with staff.
6. Context - Barriers and facilitators to implementation. Assessed via semi-structured interviews with participating children, parents/guardians and Pathways staff.
7. Recruitment Rates. Assessed by comparing the number of children enrolled in Pathways compared to the number of children who agreed to participate in the study
8. Full completion rates per assessment item (Number of items completed per participant)
9. Time to complete full assessment. Assessed via the use of a stopwatch
10. Loss to follow-up - The number of participants who agreed to participate and completed the pre-assessment items compared to the number who completed the post-assessment.
11. Acceptability – Assessed via semi-structured interviews with participating children, parents/guardians and Pathways staff.
Timepoint [1] 298148 0
Immediately following completion of the 10-week Fit for Play program.
Secondary outcome [1] 323278 0
Changes in physical competence (composite secondary outcome): Body composition (Body mass index, waist circumference), Fundamental movement skill performance (The Canadian Assessment of Physical Literacy obstacle Course, PLAYfun), Aerobic Fitness (YMCA 3-minute step test), Muscular strength (Grip strength), Muscular Endurance (Maximal plank hold).
Timepoint [1] 323278 0
Pre-assessment (within 2 weeks of commencing 10-week therapeutic program including Fit for Play) Immediately post (1-2 weeks post therapeutic program including Fit for Play) 3-months post program 6-months post program.
Secondary outcome [2] 323279 0
Changes in motivation and confidence for physical activity: Self-determination theory based Questionnaire.
Timepoint [2] 323279 0
Pre-assessment (within 2 weeks of commencing 10-week therapeutic program including Fit for Play) Immediately post (1-2 weeks post therapeutic program including Fit for Play) 3-months post program 6-months post program
Secondary outcome [3] 323280 0
Changes in knowledge and understanding of physical activity: Knowledge and Understanding Questions modified from the Canadian Assessment of Physical Literacy and the Activity Support Scale for multiple groups.
Timepoint [3] 323280 0
Pre-assessment (within 2 weeks of commencing 10-week therapeutic program including Fit for Play) Immediately post (1-2 weeks post therapeutic program including Fit for Play) 3-months post program 6-months post program
Secondary outcome [4] 354827 0
Physical Activity Levels - Actigraph GTX3. Physical activity levels will be determined via:
a. Sedentary Activity (<800 counts per minute)
b. Moderate-to-vigorous physical activity (>3200 counts per minute)
c. Number of moderate-to-vigorous bouts lasting longer than 10 minutes
Timepoint [4] 354827 0
Pre-assessment (within 2 weeks of commencing 10-week therapeutic program including Fit for Play) Immediately post (1-2 weeks post therapeutic program including Fit for Play) 3-months post program 6-months post program

Eligibility
Key inclusion criteria
Children must have a mental health disorder and be enrolled in the Pathways therapeutic day program - a specialised unit conducted by the Western Australian Child and Adolescent Mental Health Service - within the research time frame.
Before entering the program, children participate in a comprehensive multidisciplinary assessment including psychiatric, educational, psychological, occupational therapy and speech pathology evaluation. Children who require specialist attention in one or more of these areas are enrolled in the 10-week therapeutic program.
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion will occur only if a doctor, physiotherapist, occupational therapist or other allied health professional considers it unsafe for that child to participate in exercise.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Absolute individual change in each outcome measured will be determined across the assessment time points. Paired samples t-tests will be used to compare the mean scores of the pre and post test outcomes for each assessment item to determine whether any statistically relevant change occurred. Significance will be accepted at p=0.05

Change in PA levels will be considered clinically relevant if:
• Children meet (or more frequently meet) the recommended daily levels of PA (minimum of 60 minutes per day of moderate-to-vigorous PA
• Or children increase the number of moderate-to-vigorous PA bouts participated in each day
• Or children decrease their sedentary time
Long-term improvements in one or more of the above outcomes (i.e. meeting recommended PA levels, increasing PA bouts, or decreasing sedentary time) have been reported to favourably influence individual’s health therefore any positive changes seen will be considered clinically relevant.

Process Evaluation:
1. Recruitment Rates
1a. Number of children enrolled in Pathways compared to the number of children who agreed to participate in the study)
2. Adherence to the prescribed program
2a. Implementer notes – to be completed each session noting what was actually completed in each session. This will be compared to the original session plan.
2b. Participant diary’s – Participants will be asked to log the number of days they completed the at home exercises each week and how long they spent completing these exercises.
3. Full completion rates per assessment item
3a Number of assessment items successfully completed compared to number of assessment items
4. Time to complete full assessment
5. Loss to follow-up
5a. Number of participants who agreed to participate and completed the pre-assessment items compared to the number who completed the post-assessment.
6. Acceptability
6a. Assessed via semi-structured interview questions. These questions will be asked to Pathways staff, Exercise Specialists, children and parents/guardians (Seeking to determine satisfaction around Fit for Play, intent to continue to include Fit for Play into the Pathways timetable, perceived appropriateness of Fit for Play from the perspective of Pathways staff, exercise specialists, parents/guardians and participating children)
6b. Responses will be analysed as per the Framework approach.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/02/2019
Actual
Date of last participant enrolment
Anticipated
3/06/2019
Actual
Date of last data collection
Anticipated
31/01/2020
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 293480 0
Government body
Name [1] 293480 0
Australian Government, Department of Education and Training- Australian Postgraduate Award
Country [1] 293480 0
Australia
Funding source category [2] 293481 0
University
Name [2] 293481 0
University of Western Australia - PhD Top up Scholarship and Internal Department funds
Country [2] 293481 0
Australia
Primary sponsor type
Individual
Name
Kathryn Fortnum
Address
The School of Sport Science, Exercise and Health, The University of Western Australia
M408, 35 Stirling Hwy
Crawley, WA, 6009
Country
Australia
Secondary sponsor category [1] 292303 0
None
Name [1] 292303 0
Address [1] 292303 0
Country [1] 292303 0
Other collaborator category [1] 278981 0
Individual
Name [1] 278981 0
Catherine Elliott
Address [1] 278981 0
Clinical Research and Education, Princess Margaret Hospital, Roberts Road
Subiaco, WA 6008
Country [1] 278981 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294923 0
Child and Adolescent Health Service Ethics Committee
Ethics committee address [1] 294923 0
Ethics committee country [1] 294923 0
Australia
Date submitted for ethics approval [1] 294923 0
08/12/2015
Approval date [1] 294923 0
09/07/2018
Ethics approval number [1] 294923 0
Ethics committee name [2] 294925 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [2] 294925 0
Ethics committee country [2] 294925 0
Australia
Date submitted for ethics approval [2] 294925 0
18/05/2016
Approval date [2] 294925 0
Ethics approval number [2] 294925 0

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

Contacts
Principal investigator
Name 65490 0
Dr Simon Davies
Address 65490 0
Perth Children's Hospital, 15 Hospital Avenue, Nedlands, WA, 6009
Country 65490 0
Australia
Phone 65490 0
+61 8 6456 4940
Fax 65490 0
Email 65490 0
[email protected]
Contact person for public queries
Name 65491 0
Kathryn Fortnum
Address 65491 0
The School of Sport Science, Exercise and Health, The University of Western Australia,
M408, 35 Stirling Hwy
Crawley, WA, 6009
Country 65491 0
Australia
Phone 65491 0
+61 8 6488 2361
Fax 65491 0
+61 8 6488 1039
Email 65491 0
[email protected]
Contact person for scientific queries
Name 65492 0
Catherine Elliott
Address 65492 0
Perth Children's Hospital, 15 Hospital Avenue, Nedlands, WA, 6009
Country 65492 0
Australia
Phone 65492 0
+61 8 9380 2109
Fax 65492 0
Email 65492 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
Only group data will be available for this trial.


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.