Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12617000538347
Ethics application status
Approved
Date submitted
7/04/2017
Date registered
13/04/2017
Date last updated
13/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A school-based intervention for supporting the social, communication and friendship skills of children with autism and their classmates
Scientific title
A school-based intervention for supporting the social, communication and friendship skills of children with autistic spectrum disorders (ASD) and their classmates: a multi-site randomised controlled trial (RCT).
Secondary ID [1] 291634 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Social difficulities 302759 0
communication difficulities 302760 0
Autistic spectrum disorders 302842 0
Condition category
Condition code
Mental Health 302275 302275 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will primarily be implemented by the class teacher of the child with autism within the classroom. During the one-term intervention (8 weeks), the child with autism will watch a DVD episode with their class once per week (15-20 minutes). We also request parents watch the corresponding episode each week at home with their child to reinforce the skills being worked on by the whole class at school.. The intervention DVD is pre-taped, where youth who are actors model the desired skills. There is a superhero theme used throughout the DVD to appeal to children. The DVD contains 10 episodes, each focusing on a social or communication skill children with autism find difficult (e.g., perspective-taking, sharing, initiating interactions, repetitive play). During the week, the teacher will facilitate discussions with the child/their class before and after they go out to lunch (reminding them about the things they have learnt from the DVD). The discussions will occur Monday-Friday and last approximately 3-5 minutes before and after lunch.
There is also a video-modelling project where children film themselves playing/interacting during class activities and watch the footage back to the class and discuss it (these activities will happen with the whole class). The video-modelling project is a one-off project that will occur in the last week of the intervention. it is anticipated to take one hour from filming to class discussions. However, this will vary slightly depending on the individual teacher and their classroom routine/schedule.
Three class buddies will be selected by the teacher and trained by the researcher. The researcher will train the buddies for 30 minutes at the start of week one of the intervention. During the term the buddies will help facilitate social interactions in the playground for all children in their class.
Adherence will be monitored by researchers using a weekly checklist. Reasons for non-adherence of activities will be recorded (e.g., school camp, children away).
Intervention code [1] 297708 0
Behaviour
Comparator / control treatment
Half of the participants (schools) that enter the study will be randomly assigned to a waitlist control group. The control group will wait for 1 school term (8 weeks) before they receive the intervention. During the waitlist term, children will continue with all usual school activities.
Control group
Active

Outcomes
Primary outcome [1] 301685 0
Children's social play skills
Timepoint [1] 301685 0
The Test of Playfulness (ToP; Bundy, 2004) is an observational measure will be administered during 1) the control period, 2) from pre to post intervention and 3) at the 2 month follow-up.
Primary outcome [2] 301686 0
Children's pragmatic commuication skills
Timepoint [2] 301686 0
The Pragmatics Observational Measure (POM; Cordier et al. 2014) will be administered during 1) the control period, 2) from pre to post intervention and 3) at the 2 month follow-up.
Secondary outcome [1] 333563 0
Composite secondary outcome: Social skills (as reported by teachers and parents)
Timepoint [1] 333563 0
A teacher-rated social skills measure (School Social Behaviour Scales-2; SSBS-2) will be used for the three selected buddies at pre- and post-intervention. The SSBS-2 will be completed for children with autism pre-intervention, post-intervention and 2 months following intervention.
Parent-rated social skills (Home and Community Social Behaviour Scales; HCSBS) and communication skills measures (Children's Communication Checklist-2; CCC-2) will be used for children with autism pre-intervention, post-intervention and 2 months following intervention.

Eligibility
Key inclusion criteria
Children with autism: need to have a formal diagnosis of autism (made by a paediatrician or psychiatrist using recognised diagnostic procedures e.g. ADOS/DSM-IV). Children with autism need to attend a mainstream school and attend a mainstream classroom.

Typically-Developing class buddies: No diagnosis of autism/other developmental disorders and no concerns raised by parents or teachers about the children’s development.

The Conners Comprehensive Behavior Rating Scales (CCBRS; Conners, 2008) will be used as a screening measure to confirm the presence or absence of autism symptoms. Children with autism need to score above the clinical cut off (T-Score >70) and class buddies needed to score below the borderline clinical cut off (T-score <65)
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children with autism will be included if they have a dual diagnosis where ADHD is included, provided autism is the primary diagnosis. Children with autism will be excluded if they are diagnosed with intellectual disability.

Class buddies will be excluded if they scored above the clinical cut off on the CCBRS.

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)
Simple central randomisation randomisation using a randomisation table created by computer software will be used to allocate participating schools across Sydney and Perth to either a control or intervention group using numbers 1-20. This study has been funded for 20 schools/children with autism. The randomisation table/list will be generated by the research team prior to participants entering the study. Children will be allocated to number 1-20 (once randomised) in the order they join the study. Researchers will only collect information about the child relating to the inclusion criteria prior to entry in the program (e.g., diagnosis of autism). The child's age, gender etc. will not be collected until an initial meeting with the school and parent takes place, once the child has been allocated to the intervention or control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software will be used to allocate participating schools across Sydney and Perth to either a control or intervention group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on 3 previous pilot studies and power/sample size calculations, we determined the sample size needed was 15 children with autism per group. To calculate sample size we used the G Power calculator and input the: 1) desired power (e.g., 0.8), 2) statistical test (e.g., ANOVA), 3) alpha value (0.05) and 4) expected e ect (>.5 large); which generated the
minimum sample needed n = 30. The study was funded for 20 children with autism.

Anticipated statistical analysis includes: One-way repeated measures ANOVA with post-hoc LSD and Cohen's'-d e ect sizes to determine the e cacy of the intervention, and Stepwise linear regression model analysis to determine variables that predict intervention change..

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/04/2017
Date of last participant enrolment
Anticipated
30/05/2017
Actual
Date of last data collection
Anticipated
29/09/2017
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA

Funding & Sponsors
Funding source category [1] 296127 0
Charities/Societies/Foundations
Name [1] 296127 0
The Ian Potter Foundation
Country [1] 296127 0
Australia
Funding source category [2] 296150 0
University
Name [2] 296150 0
The Australian Catholic University
Country [2] 296150 0
Australia
Funding source category [3] 296151 0
University
Name [3] 296151 0
Curtin University
Country [3] 296151 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
33 Berry Street North Sydney, NSW 2060
Country
Australia
Secondary sponsor category [1] 295050 0
None
Name [1] 295050 0
Address [1] 295050 0
Country [1] 295050 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297381 0
Human Research Ethics Committee, Australian Catholic University
Ethics committee address [1] 297381 0
Ethics committee country [1] 297381 0
Australia
Date submitted for ethics approval [1] 297381 0
30/09/2015
Approval date [1] 297381 0
04/03/2016
Ethics approval number [1] 297381 0
2015-250H
Ethics committee name [2] 297396 0
Human Ethics Research Committee Curtin University
Ethics committee address [2] 297396 0
Ethics committee country [2] 297396 0
Date submitted for ethics approval [2] 297396 0
22/09/2016
Approval date [2] 297396 0
10/11/2016
Ethics approval number [2] 297396 0
HRE2016-0315
Ethics committee name [3] 297397 0
Research Centre Sydney Catholic Schools
Ethics committee address [3] 297397 0
Ethics committee country [3] 297397 0
Australia
Date submitted for ethics approval [3] 297397 0
01/11/2016
Approval date [3] 297397 0
29/03/2017
Ethics approval number [3] 297397 0
No ID given

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73862 0
Dr Sarah Wilkes-Gillan
Address 73862 0
Australian Catholic university
33 Berry Street North Sydney
NSW 2060
Country 73862 0
Australia
Phone 73862 0
+61 402402359
Fax 73862 0
Email 73862 0
[email protected]
Contact person for public queries
Name 73863 0
Sarah Wilkes-Gillan
Address 73863 0
Australian Catholic University
33 Berry Street North Sydney
NSW 2060
Country 73863 0
Australia
Phone 73863 0
+61 402402359
Fax 73863 0
Email 73863 0
[email protected]
Contact person for scientific queries
Name 73864 0
Sarah WIlkes-Gillan
Address 73864 0
Australian Catholic University
33 Berry Street North Sydney
NSW 2060
Country 73864 0
Australia
Phone 73864 0
+61 402402359
Fax 73864 0
Email 73864 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.