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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

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

prematurity

Condition category

Condition code

Physical Medicine / Rehabilitation

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]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Once 42 circus coaches are enrolled

Primary outcome [2]

Intervention acceptability will be assessed by retention & attrition and Theoretical Framework of Acceptability (TFA) questionnaire

Timepoint [2]

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]

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]

Collected weekly, evaluated at end of intervention period

Secondary outcome [1]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

National Health and Medical Research Council of Australia Centre of Research Excellence in Newborn Medicine #1153176.

Address [1]

Centre for Research Excellence in Newborn Medicine
Murdoch Children's Research Centre
Royal Children’s Hospital
Flemington Road
Parkville, VIC, 3052

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

The University of Melbourne

Address [1]

Parkville
Victoria
3010

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Children's Hospital Human Research Ethics Committee

Ethics committee address [1]

Royal Children’s Hospital
Flemington Road
Parkville, VIC, 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/04/2022

Approval date [1]

12/07/2022

Ethics approval number [1]

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

Ms Free Coulston

Address

Department of Physiotherapy
University of Melbourne
Parkville, Vic
3000

Country

Australia

Phone

+61 0414653218

Fax

free.coulston@mcri.edu.au

Contact person for public queries

Name

Free Coulston

Address

Department of Physiotherapy
University of Melbourne
Parkville, Vic
3000

Country

Australia

Phone

+61 0414653218

Fax

free.coulston@mcri.edu.au

Contact person for scientific queries

Name

Free Coulston

Address

Department of Physiotherapy
University of Melbourne
Parkville, Vic
3000

Country

Australia

Phone

+61 0414653218

Fax

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.	Type	Email
15535	Study protocol	free.coulston@mcri.edu.au
15536	Statistical analysis plan	free.coulston@mcri.edu.au
15537	Informed consent form	free.coulston@mcri.edu.au
15539	Ethical approval	free.coulston@mcri.edu.au

Results publications and other study-related documents

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