Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001266156
Ethics application status
Approved
Date submitted
27/08/2019
Date registered
12/09/2019
Date last updated
2/02/2022
Date data sharing statement initially provided
12/09/2019
Date results information initially provided
16/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dance PREEMIE: A Dance Participation intervention for Extremely Preterm Children with Motor Impairment at Preschool age: a feasibility trial.
Scientific title
Dance PREEMIE: A Dance Participation intervention for Extremely Preterm Children with Motor Impairment at Preschool age: a feasibility trial.
Secondary ID [1] 299067 0
None
Universal Trial Number (UTN)
Trial acronym
Dance PREEMIE: feasibility trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children born preterm 314093 0
Motor impairment 314094 0
Condition category
Condition code
Neurological 312472 312472 0 0
Other neurological disorders
Reproductive Health and Childbirth 312660 312660 0 0
Complications of newborn
Physical Medicine / Rehabilitation 312724 312724 0 0
Other physical medicine / rehabilitation
Musculoskeletal 312725 312725 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of two stages.
Stage 1: All participating dance teachers will receive face-to face physiotherapy-led training on teaching children with motor impairments and about motor learning principles. This training will be delivered at the Royal Children's Hospital, Melbourne, Australia in a single session of 3-4 hours. The session will be delivered in small groups of 2-5 dance teachers. Dance training sessions will take place prior to the commencement of Term 4 2019 and Term 1 2020. Participating dance teachers are only required to attend one session. In addition, dance teachers will be provided with supporting material in the form of an educational package. This educational package will be available as supplementary material to the published protocol. Session content was developed specifically for this study in accordance with relevant literature on participation and motor skill development in children with motor impairment. A member of the research team will be contactable throughout the study to assist with any queries or provide additional support for the participating dance teachers.
Stage 2: Once informed consent is obtained, children will be matched with a dance class within an acceptable distance of the family’s home. These dance classes will be existing dance classes, and so attended by members of the public who are not participating in the study, as well as by study participants. The dance classes will be taught by a teacher who has attended the training session (stage 1). Dance teachers will aim to include motor learning strategies into their dance class. Examples of this include; repetition of movements, specificity, salience (focus on fun and engagement) and adapting dance steps and environment to enable just the right amount of challenge. Use of appropriate modelling and feedback types and frequency will also be encouraged. Implementation fidelity refers to the extent to which individuals (dance teachers) implement to intervention protocol (adherence), and the skillfulness of delivery (competence). Implementation fidelity will be monitored through observation performance evaluation using a predetermined checklist (available as supplementary material as part of published protocol) based upon the education session content. Each dance teacher will be observed twice throughout the intervention period by the same member of the research team in order to minimize inter-rater bias. Children will be enrolled to attend the dance class once per week for 8 weeks. Dance classes are likely to be variable in duration, but must be between 30-60 minutes. Dance class fees will be fully subsidised to facilitate involvement in the study and minimise financial barriers to participation. An attendance form will be completed by dance teachers throughout the term. An enjoyment scale will be completed by parents and children after each class.
Intervention code [1] 315334 0
Rehabilitation
Intervention code [2] 315498 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321112 0
To determine the feasibility of the intervention. This is a composite primary outcome comprising of study recruitment rates and attendance and attrition, for both participating children and dance teachers,
Timepoint [1] 321112 0
Study recruitment will be determined by comparing number of eligible participants approached compared with those who consented.
Attendance will be recorded each week at the dance class by the dance teacher.
Participants who withdraw from the study will be noted, with reasons given (if known).
Primary outcome [2] 321114 0
Acceptability of the intervention will be determined through semi-structured interviews with parents and dance teachers, and through a smiley face enjoyment scale completed by participating children. Acceptability is a composite primary outcome, and is theoretically based upon the Theoretical Framework of Acceptability (TFA).
Timepoint [2] 321114 0
Smiley face: weekly after dance class. Parent to complete with child and bring to final assessment.
Semi-structured interviews: Both parents and teachers will complete a one on one interview with a member of the research team. These will be audio-recorded and 30-40 minutes in duration. Interviews can be completed over the phone or in person (participant preference).
Primary outcome [3] 321115 0
Implementation fidelity of the dance intervention: This involves the extent to which dance teachers are able to implement the strategies covered during the training session. This will be measured through an implementation fidelity checklist completed by a researcher directly observing dance classes.
Timepoint [3] 321115 0
Direct observation/checklist: Each class observed twice throughout intervention period.
These timepoints will be chosen pragmatically based on the availability of the investigator and the location of the dance class.
Secondary outcome [1] 374035 0
Movement Assessment Battery for Children; 2nd edition is considered the gold standard at assessing for motor impairment for children 3 to 16 years of age. The assessment is divided into subscales, manual dexterity, aiming and catching and balance.
Timepoint [1] 374035 0
Pre intervention (1 week prior to intervention)
Post-intervention (after 8 weeks of class)
Secondary outcome [2] 374036 0
Preschool-age Physical Activity Questionnaire (Pre-PAQ) is a validated questionnaire developed in an Australian context and is designed to capture information on sedentary behaviour and physical activity time, including structured physical activity
Timepoint [2] 374036 0
1 week prior to intervention, after 8 weeks of class, and 3 months post intervention
Secondary outcome [3] 374037 0
Canadian Occupational Performance Measure (COPM) is a goal setting and rating tool completed by therapists and parents through collaborative discussion. Gross motor or participation goals will be encouraged.
Timepoint [3] 374037 0
Pre intervention (1 week prior to intervention)
Post-intervention (after 8 weeks of class)
Secondary outcome [4] 374038 0
Child participation in dance classes will be recorded using a form completed by the dance teacher. Participation is comprised of both attendance in dance classes, as well as involvement in the task.
Timepoint [4] 374038 0
The teacher will complete this form on a weekly basis, and return to the study at the completion of the intervention (after 8 weeks of class).
Secondary outcome [5] 374039 0
Strengths and Difficulties Questionnaire (SDQ): This questionnaire provides information about emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems and prosocial behaviour.
Timepoint [5] 374039 0
Pre-intervention: one week prior to intervention beginning.
Secondary outcome [6] 374275 0
Dance teacher self-efficacy: Dance teachers will be asked to rate their self-efficacy on teaching children with motor impairment on a 10 point scale Likert scale.
Timepoint [6] 374275 0
Immediately prior to training, immediately after training, and after teaching 8 weeks of classes.

Eligibility
Key inclusion criteria
Children must fulfil all of the following:

1) be part of the Victorian Infant Collaborative Study (VICS) 2016/2017 cohort, and be born extremely preterm (<28 weeks' gestation) or extremely low birth weight (<1000g) at the Royal Women's Hospital, Melbourne, Australia
2) have motor impairment, defined as scoring >1SD below the mean (established by the VICS 2005 term control cohort) on the mean motor score of the Bayley III Scale of Infant and Toddler Development assessed at 2 years of age. A mean value established from a contemporary cohort of healthy, term born Australian children will decrease the likelihood the Bayley-III will under predict motor impairment.
3) be three years corrected age at the beginning of the intervention period.

Dance teachers must:
1. be teaching a preschool dance class
2. be able to attend a training session
3. have a valid Working with Children Check
4. have a valid First Aid certificate (or have a staff member in the studio who is the designated first aider)
Minimum age
3 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children: exclusion criteria
1. Children who are unable to consistently follow simple commands (due to global developmental delay, receptive language disorders etc.)
2. Children who are non-ambulant.
3. Children who have any medical condition that precludes participation in physical activity.

Dance teachers: exclusion criteria
1. Dance schools outside 100km radius of Murdoch Children's Research Institute, Melbourne
2. Dance classes are not conducted in English

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)
Not an RCT
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We aim to recruit 10 children plus the number of dance teachers required to teach the recruited children (number unknown as this is a feasibility study) Descriptive data will be used for participant characteristics. Results for all quantitative outcome measures at each data collection point will be described using descriptive statistics.
Thematic analysis will be used to analyse semi-structured interviews.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/09/2019
Actual
2/09/2019
Date of last participant enrolment
Anticipated
3/02/2020
Actual
10/02/2020
Date of last data collection
Anticipated
23/07/2020
Actual
28/04/2020
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 303602 0
Charities/Societies/Foundations
Name [1] 303602 0
Physiotherapy Research Foundation
Country [1] 303602 0
Australia
Primary sponsor type
Other
Name
Murdoch Children's Research Institute
Address
The Royal Children's Hospital, Flemington Road, Parkville, VIC, 3052
Country
Australia
Secondary sponsor category [1] 303688 0
None
Name [1] 303688 0
Address [1] 303688 0
Country [1] 303688 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304131 0
The Royal Children's Hospital Research Ethics and Governance Committee
Ethics committee address [1] 304131 0
50 Flemington Road Parkville Victoria 3052
Ethics committee country [1] 304131 0
Australia
Date submitted for ethics approval [1] 304131 0
Approval date [1] 304131 0
12/10/2018
Ethics approval number [1] 304131 0
Ethics committee name [2] 304142 0
The Royal Women's Hospital Research and Human Ethics Committee
Ethics committee address [2] 304142 0
Cnr Grattan Street and Flemington Road, Parkville Victoria, Australia, 3052
Ethics committee country [2] 304142 0
Australia
Date submitted for ethics approval [2] 304142 0
Approval date [2] 304142 0
12/10/2018
Ethics approval number [2] 304142 0

Summary
Brief summary
The aim of this study is to assess feasibility, including the acceptability and fidelity, of a preschool dance participation intervention for extremely preterm (EP) children with motor impairment. Children born EP (<28 weeks gestation) are at increased risk of motor difficulty compared to children born at term. Motor skills developed during the preschool years provide the foundation for the development of more complex motor skills, and facilitate participation in lifelong physical activity (PA). Current evidence suggests that motor impairment in EP children persists throughout childhood and adolescence, with relevance for lifelong PA participation and associated health outcomes. A feasibility case series trial will recruit EP preschool age children with motor impairment from the Victorian Infant Collaborative Study 2016 cohort at the Royal Women’s Hospital (n=10). Melbourne based dance teachers will be recruited and provided with physiotherapy-led training and support to facilitate the participation of EP children in community dance classes. A mixed-methods approach (quantitative and qualitative) will be used to analyse the acceptability and feasibility of the intervention from the perspectives of families and dance teachers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95918 0
A/Prof Alicia Spittle
Address 95918 0
Department of Physiotherapy, The University of Melbourne, 7th Floor, 161 Barry Street, Parkville, Victoria, Australia, 3052
Country 95918 0
Australia
Phone 95918 0
+61390355390
Fax 95918 0
Email 95918 0
aspittle@unimelb.edu.au
Contact person for public queries
Name 95919 0
Ms Kate Cameron
Address 95919 0
VIBeS research group. Murdoch Children's Research Group, 50 Flemington Road, Parkville, 3052, VIC, Australia
Country 95919 0
Australia
Phone 95919 0
+61 491629168
Fax 95919 0
Email 95919 0
kate.cameron@mcri.edu.au
Contact person for scientific queries
Name 95920 0
Ms Kate Cameron
Address 95920 0
VIBeS research group. Murdoch Children's Research Group, 50 Flemington Road, Parkville, 3052, VIC, Australia
Country 95920 0
Australia
Phone 95920 0
+61 491629168
Fax 95920 0
Email 95920 0
kate.cameron@mcri.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethics for this.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4346Study protocolCameron, K. L., McGinley, J. L., Allison, K., Fini, N. A., Cheong, J. L. Y., & Spittle, A. J. (2020). Dance PREEMIE, a Dance PaRticipation intervention for Extremely prEterm children with Motor Impairment at prEschool age: an Australian feasibility trial protocol. BMJ Open, 10(1), e034256. https://doi.org/10.1136/bmjopen-2019-034256   Study protocol will be published.



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Cameron, K. L., Allison, K., McGinley, J. L., Fini... [More Details]
Study results articleYes Cameron KL, McDonald CE, Allison K, McGinley JL, C... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDance PREEMIE, a Dance PaRticipation intervention for Extremely prEterm children with Motor Impairment at prEschool age: An Australian feasibility trial protocol.2020https://dx.doi.org/10.1136/bmjopen-2019-034256
EmbaseFeasibility of a Dance PaRticipation intervention for Extremely prEterm children with Motor Impairment at prEschool age (Dance PREEMIE).2021https://dx.doi.org/10.1016/j.earlhumdev.2021.105482
N.B. These documents automatically identified may not have been verified by the study sponsor.