Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000532707
Ethics application status
Approved
Date submitted
24/03/2022
Date registered
5/04/2022
Date last updated
22/05/2023
Date data sharing statement initially provided
5/04/2022
Date results information initially provided
22/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
CirqAll: a feasibility study of a novel co-designed online training program for circus coaches working with preschool-aged children born preterm
Scientific title
CirqAll: a feasibility case series study of a novel co-designed physical activity intervention for preschool children born preterm.
Secondary ID [1] 306759 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prematurity 325768 0
Condition category
Condition code
Physical Medicine / Rehabilitation 323105 323105 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will undertake a feasibility trial of a novel co-designed online training program for circus coaches working with children born preterm: 'CirqAll: preschool circus for premmies'.

Circus coaches will complete online professional development training. There are 4 modules on an online platform (FutureLearn, hosted by The University of Melbourne) which coaches complete individually over 2-4 weeks, in a self-directed manner. There are also 4 group-based online Zoom workshops as part of this professional development. Each of the 4 self-directed modules takes approximately 2.5 hours to complete, and each Zoom workshop is 90 minutes, for a total time of 16 hours. Two delivery formats will be offered for the training to optimise recruitment. Participants will self-select into, either a 2-week intervention period with Zoom workshops delivered on two consecutive weekends, or a 4-week intervention period with Zoom workshops delivered once per week. In either case, coaches can complete the self-directed Module content flexibly, but prior to each Zoom session.

As this is a feasibility trial, evaluation of intervention fidelity is one of the main outcomes. Fidelity assessment will measure both structure (e.g., adherence and dosage) and process (e.g., quality of delivery).

Adherence will be quantified using a checklist of agenda items for the Zoom workshops. Agenda items will be marked by the workshop facilitator as 'Present' (score of 2), 'Attempted' (score of 1) or 'Absent' (score of 0). The overall adherence score will be calculated as a percentage of the total possible score.
Dosage will be quantified by:
o Number of coaches with 50% or more step completion, and
o Number of coaches with 90% or more step completion, and
o Number of Zoom workshops attended
Participant responsiveness will be measured using a 5-point Likert scale. Coaches will anonymously rate their involvement during each workshop on an online REDCap survey, from 1 = not at all involved/engaged to 5 = very involved/engaged.
Intervention code [1] 323208 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330873 0
Recruitment capability will be assessed by recruitment rates and duration of recruitment. To assess the capability of the recruitment strategy, numbers of participants (circus coaches) expressing interest (via a REDCap form) will be compared with numbers of enrolled participants. Reasons for exclusion or non-enrolment will be recorded. The duration of the recruitment period (the time from enrolment opening to final participant enrolled) and any challenges to recruitment will be recorded to provide further insight into the suitability of the recruitment strategy.
Timepoint [1] 330873 0
Once 42 circus coaches are enrolled
Primary outcome [2] 330874 0
Intervention acceptability will be assessed by retention & attrition and Theoretical Framework of Acceptability (TFA) questionnaire
Timepoint [2] 330874 0
Retention & attrition (end of intervention period); Theoretical Framework of Acceptability Questionnaire (within 2 weeks prior to, and within 2 weeks after completion of online training - circus coaches to self-complete).
Primary outcome [3] 330875 0
Implementation fidelity will be assessed by adherence, dosage & participant responsiveness. Adherence will be quantified using a checklist of agenda items for the Zoom workshops. Agenda items will be marked by the workshop facilitator as 'Present' (score of 2), 'Attempted' (score of 1) or 'Absent' (score of 0). The overall adherence score will be calculated as a percentage of the total possible score. Dosage will be quantified by: Number of coaches with 50% or more step completion, and number of coaches with 90% or more step completion, and number of Zoom workshops attended. Participant responsiveness will be measured using a 5-point Likert scale. Coaches will anonymously rate their involvement during each workshop on an online REDCap survey, from 1 = not at all involved/engaged to 5 = very involved/engaged.
Timepoint [3] 330875 0
Collected weekly, evaluated at end of intervention period
Secondary outcome [1] 407892 0
Limited efficacy testing of coaches self-efficacy is also a primary outcome and will be evaluated using the Determinants of Implementation Behaviour Questionnaire (DIBQ).
Timepoint [1] 407892 0
DIBQ will be administered to coaches within 2 weeks prior to, and within 2 weeks post completion of online training.

Eligibility
Key inclusion criteria
Inclusion criteria:
Each participant must meet all of the following criteria to be enrolled in this trial:
• Is 16 years or older at the time of enrolment
• Has taught more than 30 hours of circus skills to children aged 3-5 years old
• Has taught circus skills to children aged 3-5 years old in the past five years in Australia
• Has access to the internet and a device that connects to the internet
• Be able to comprehend both written and spoken English.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria: Coaches
There are no exclusion criteria for coaches.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation is not concealed
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a feasibility trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Although feasibility studies do not require sample sizes with adequate power to perform statistical hypothesis testing (Orsmond & Cohn, 2015), a sample size of 42 coaches is anticipated to provide adequate information regarding the feasibility of the online coach training. A sample size of 42 coaches is required to obtain a 95% confidence interval of +/- 10% around an acceptability percentage estimate of 90% (i.e. expected 95% confidence interval 80% to 100%).

The data obtained from the small samples in the feasibility study will help to determine sample sizes for a larger randomised trial of CirqAll, if a large trial proves to be feasible in the future.

Descriptive statistics will be used to analyse the data collected in this study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/07/2022
Actual
21/07/2022
Date of last participant enrolment
Anticipated
9/09/2022
Actual
3/09/2022
Date of last data collection
Anticipated
30/12/2022
Actual
11/01/2023
Sample size
Target
42
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311098 0
Other Collaborative groups
Name [1] 311098 0
National Health and Medical Research Council of Australia Centre of Research Excellence in Newborn Medicine #1153176.
Country [1] 311098 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Murdoch Children's Research Centre
Address
Royal Children’s Hospital
Flemington Road
Parkville, VIC, 3052
Country
Australia
Secondary sponsor category [1] 312428 0
None
Name [1] 312428 0
Address [1] 312428 0
Country [1] 312428 0
Other collaborator category [1] 282229 0
University
Name [1] 282229 0
The University of Melbourne
Address [1] 282229 0
Parkville
Victoria
3010
Country [1] 282229 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310631 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 310631 0
Royal Children’s Hospital
Flemington Road
Parkville, VIC, 3052
Ethics committee country [1] 310631 0
Australia
Date submitted for ethics approval [1] 310631 0
08/04/2022
Approval date [1] 310631 0
12/07/2022
Ethics approval number [1] 310631 0
HREC/84753/RCHM-2022

Summary
Brief summary
The aim of this study is to undertake a feasibility trial of a novel co-designed online training program for circus coaches 'CirqAll: preschool circus for premmies', to determine:
I. The effectiveness of study recruitment strategies to enrol sufficient appropriate coaches,
II. The acceptability of the intervention to participating circus coaches,
III. The implementation fidelity of the intervention, and
IV. Limited efficacy testing on a key outcome of interest: coaches' implementation behaviour.

Despite the demonstrated benefits of PA, and circus training specifically, there is a scarcity of literature on how to tailor these activities to address the participation gap between children born preterm and their term born peers at the preschool age. A recent study by the authors of this protocol was carried out to identify the preferences of key stakeholders regarding recreational physical activities for children born preterm (<28 weeks' gestation). This study identified that parents of preterm children require greater understanding of the preterm experience, which could be addressed by additional training for coaches. Furthermore, parents' heightened vigilance, risk aversion and diverse needs of their children requires tailoring of programs to support initial engagement, and ongoing participation, in recreational physical activities. Using this information, a circus-based intervention was co-designed with key stakeholders to address the needs identified. The co-designed intervention was named 'CirqAll: preschool circus for premmies'. The current study aims to test the feasibility of the CirqAll online training program for circus coaches.

If there are few previously published studies or existing data using a specific intervention technique, such as this study which proposes a novel intervention (Bowen et al., 2009), it is important to assess its feasibility. Intervention effectiveness research can be accelerated if careful feasibility studies are conducted prior to larger trials (Orsmond & Cohn, 2015). To prevent wasted resources (participant and researcher time, funding, administration etc.), it is important to evaluate and prioritize interventions with the greatest likelihood of being efficacious. The purpose of feasibility testing is to produce a set of findings that help determine whether an intervention should be recommended for efficacy testing, and identify not only what—if anything—in the research methods or protocols needs modification but also how changes might occur (Bowen et al., 2009; Orsmond & Cohn, 2015). This case series feasibility study will provide insight into whether this novel intervention can work. Furthermore, it will identify what, and how, changes might occur, thereby preventing wasted resources.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118326 0
Ms Free Coulston
Address 118326 0
Department of Physiotherapy
University of Melbourne
Parkville, Vic
3000
Country 118326 0
Australia
Phone 118326 0
+61 0414653218
Fax 118326 0
Email 118326 0
free.coulston@mcri.edu.au
Contact person for public queries
Name 118327 0
Ms Free Coulston
Address 118327 0
Department of Physiotherapy
University of Melbourne
Parkville, Vic
3000
Country 118327 0
Australia
Phone 118327 0
+61 0414653218
Fax 118327 0
Email 118327 0
free.coulston@mcri.edu.au
Contact person for scientific queries
Name 118328 0
Ms Free Coulston
Address 118328 0
Department of Physiotherapy
University of Melbourne
Parkville, Vic
3000
Country 118328 0
Australia
Phone 118328 0
+61 0414653218
Fax 118328 0
Email 118328 0
free.coulston@mcri.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
• Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures and appendices)
• Study protocol, Statistical Analysis Plan, PICF
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator (free.coulston@mcri.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15535Study protocol  free.coulston@mcri.edu.au
15536Statistical analysis plan  free.coulston@mcri.edu.au
15537Informed consent form  free.coulston@mcri.edu.au
15539Ethical approval  free.coulston@mcri.edu.au



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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