The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000008527
Ethics application status
Approved
Date submitted
16/12/2014
Date registered
8/01/2015
Date last updated
11/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A pairwise randomised control trial of a peer-to-peer play-based intervention for children with Autism Spectrum Disorder to improve social play skills and pragmatic language.
Scientific title
Improving the social play and pragmatic language outcomes of children with Autism Spectrum Disorder (ASD) using a play-based intervention by comparing children with ASD in the experimental group with children with ASD in the wait-listed group.
Secondary ID [1] 285859 0
nil
Universal Trial Number (UTN)
U1111-1165-2708
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
autism spectrum disorder 293773 0
Condition category
Condition code
Mental Health 294077 294077 0 0
Autistic spectrum 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 as they enter the playroom to remember and pre-empt play. 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] 290840 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 control group will receive standard care during the intervention period.
Control group
Active

Outcomes
Primary outcome [1] 293860 0
Social Play Skills.
Social Play skills will be assessed using the Test of Playfulness (Bundy, 2004)
Timepoint [1] 293860 0
Pre, post (10 weeks) and follow-up (3 months)
Primary outcome [2] 293946 0
Pragmatic Language.
Pragmatic Language will be assessed using the Pragmatics Observational Measure (Cordier, 2014).
Timepoint [2] 293946 0
Pre, post (10 weeks) and follow-up (3 months)
Secondary outcome [1] 312024 0
Daily social experiences of child with ASD using Experience Sampling Method
Timepoint [1] 312024 0
Pre, post (10 weeks) and follow-up (3 months)
Secondary outcome [2] 330480 0
Higher level language (receptive and expressive), will be assessed using the Social Emotional Evaluation (Wiig, 2008)
Timepoint [2] 330480 0
Pre, post (10 weeks), follow up (3 months)
Secondary outcome [3] 341877 0
Parent observations of social behaviour will be assessed using the Home and Community Social Behavior Scale
Timepoint [3] 341877 0
Pre, post (10 weeks) and follow-up (3 months)
Secondary outcome [4] 341878 0
Teacher observations of social behaviour at school will be assessed using the School Social Behavior Scale
Timepoint [4] 341878 0
Pre, post (10 weeks) and follow-up (3 months)

Eligibility
Key inclusion criteria
Autism Spectrum Disorder.
The typically developing playmates constitute healthy volunteers in the study.
Minimum age
6 Years
Maximum age
11 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
intellectual disability

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 ASD in each group (n= 48) will be required in order to generate sufficient power of the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 9063 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 290432 0
University
Name [1] 290432 0
Curtin University
Address [1] 290432 0
GPO Box U1987
School of Occupational Therapy and Social Work
Perth
WA 6845
Country [1] 290432 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
School of Occupational Therapy and Social Work
Perth WA
6845
Country
Australia
Secondary sponsor category [1] 289144 0
None
Name [1] 289144 0
Address [1] 289144 0
Country [1] 289144 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292114 0
Curtin University Human Ethics Research Committee
Ethics committee address [1] 292114 0
GPO Box U1987
Perth
WA 6845
Ethics committee country [1] 292114 0
Australia
Date submitted for ethics approval [1] 292114 0
Approval date [1] 292114 0
09/12/2014
Ethics approval number [1] 292114 0
4886

Summary
Brief summary
Children with Autism Spectrum Disorder (ASD) 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 ASD.
It is expected that following the intervention children with ASD will have improved social play and communication skills and improved ability to establish and maintain friendships. Findings from this study can be translated into clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53586 0
A/Prof Reinie Cordier
Address 53586 0
Curtin University
GPO Box U1987
Perth WA 6845
Country 53586 0
Australia
Phone 53586 0
+61404115786
Fax 53586 0
Email 53586 0
reinie.cordier@curtin.edu.au
Contact person for public queries
Name 53587 0
A/Prof Reinie Cordier
Address 53587 0
Curtin University
GPO Box U1987
Perth WA 6845
Country 53587 0
Australia
Phone 53587 0
+61404115786
Fax 53587 0
Email 53587 0
reinie.cordier@curtin.edu.au
Contact person for scientific queries
Name 53588 0
A/Prof Reinie Cordier
Address 53588 0
Curtin University
GPO Box U1987
Perth WA 6845
Country 53588 0
Australia
Phone 53588 0
+61404115786
Fax 53588 0
Email 53588 0
reinie.cordier@curtin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary