Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001026617
Ethics application status
Approved
Date submitted
14/07/2014
Date registered
24/09/2014
Date last updated
22/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A play-based intervention to improve the social play outcomes of children with Cerebral Palsy: A pairwise randomised controlled trial
Scientific title
Improving the social play outcomes of children with Cerebral Palsy (CP) using a play-based intervention by comparing children with CP in the experimental group with children with CP in the wait-listed group.
Secondary ID [1] 284975 0
Nil
Universal Trial Number (UTN)
U1111-1159-2833
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 292477 0
Condition category
Condition code
Neurological 292789 292789 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves a peer-peer play-based intervention involving self-, therapist, and peer modelling. All intervention sessions will be video-recorded to facilitate self-modelling. The researcher will begin each clinic session by showing the children video footage of themselves playing from the previous week. During the self-modelling, children will observe and reflect on edited video footage of their social play from the previous week. The researcher will use video feedback techniques by discussing the segments of their past play performance. The researcher will then use video feed-forward techniques by facilitating a problem-solving discussion with the children, helping them to develop strategies to pre-empt the changes required for future social skill development to occur. To conclude, the researcher will present the children with three key summary points to remember and pre-empt as they enter the playroom. The parent/caregiver will observe these sessions through use of a computer monitor in an adjoining room. The researcher will discuss the techniques they used with the caregiver to ensure skills transfer. The duration between treatments for the treatment and control group is 3 months. The intervention involves a clinic component which includes 1x1 hour session per week for 10 weeks and a home component which involves 1x1 hour session per week for 10 weeks.
Intervention code [1] 289803 0
Treatment: Other
Comparator / control treatment
Randomized pairwise wait-listed control group. The children will be allocated to either a control or intervention group through pair-wise randomisation after they enter the program. To minimise bias, randomisation will be concealed from the investigator. A person not involved in the study will hand the researcher an envelope determining group membership; the concealed envelope will be given to the family at the end of the baseline assessment to find out their group membership. The group membership will have been unknown to both participants and the researcher until this point. The control group will be offered the intervention after a 3 month waiting period. The will receive standard care during the intervention period.
Control group
Active

Outcomes
Primary outcome [1] 292638 0
Social play skills. Social play skills will be assessed using the Test of Playfulness (Bundy, 2004).
Timepoint [1] 292638 0
10 weeks
Secondary outcome [1] 309397 0
Pragmatic language. Pragmatic language will be assessed using the Pragmatic Observational Measure (POM; Cordier, 2014).
Timepoint [1] 309397 0
10 weeks

Eligibility
Key inclusion criteria
Unilateral Cerebral Palsy
The typically developing playmates constitute healthy volunteers in this study.
Minimum age
5 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intellectual disability
Other types of CP

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The crossover of the paired waitlisted control will be immediately after the experimental paired child completed their 10 week intervention. To minimise bias, randomisation will be concealed from the investigator. A person not involved in the study will hand the researcher an envelope determining group membership; the concealed envelope will be given to the family at the end of the baseline assessment to find out their group membership.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Comparing between group differences using linear mixed modelling analysis. Based on a Cohen’s d of 0.8, given an a-value of 0.05 and a 1-Beta of 0.8, 24 children with UCP in each group (n= 48) will be required in order to generate sufficient power of the study.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
15/10/2014
Actual
Date of last participant enrolment
Anticipated
30/06/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 8444 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 289595 0
University
Name [1] 289595 0
Curtin University
Country [1] 289595 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University
GPO Box U1987
School of Occupational Social Work
Perth
WA
6845
Country
Australia
Secondary sponsor category [1] 288279 0
None
Name [1] 288279 0
Address [1] 288279 0
Country [1] 288279 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291329 0
Curtin University Human Ethics Research Committee
Ethics committee address [1] 291329 0
GPO Box U1987
Perth
WA
6845
Ethics committee country [1] 291329 0
Australia
Date submitted for ethics approval [1] 291329 0
15/07/2014
Approval date [1] 291329 0
12/08/2014
Ethics approval number [1] 291329 0
HR 167/2014

Summary
Brief summary
Children with cerebral palsy (CP) have a number of limitations that contribute to social play and pragmatic language restrictions. Effective social play skills and pragmatic language are necessary for psychosocial development. Well developed social emotional skills and good quality relationships are protective factors that promote resilience and quality of life. The aim of this study is to evaluate the effectiveness of a peer-to-peer play based intervention to improve social play skills and pragmatic language in children with unilateral (i.e. affecting one side of the body) CP. It is expected that following the intervention children with UCP will have improved social play and communication skills and improved ability to establish and maintain friendships. Findings from this study will be directly translated into clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49918 0
A/Prof Reinie Cordier
Address 49918 0
Curtin University
GPO Box U1987
Perth
WA
6845
Country 49918 0
Australia
Phone 49918 0
+61404115786
Fax 49918 0
Email 49918 0
reinie.cordier@curtin.edu.au
Contact person for public queries
Name 49919 0
A/Prof Reinie Cordier
Address 49919 0
Curtin University
GPO Box U1987
Perth
WA
6845
Country 49919 0
Australia
Phone 49919 0
+61404115786
Fax 49919 0
Email 49919 0
reinie.cordier@curtin.edu.au
Contact person for scientific queries
Name 49920 0
A/Prof Reinie Cordier
Address 49920 0
Curtin University
GPO Box U1987
Perth
WA
6845
Country 49920 0
Australia
Phone 49920 0
+61404115786
Fax 49920 0
Email 49920 0
reinie.cordier@curtin.edu.au

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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