Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000424404
Ethics application status
Approved
Date submitted
17/03/2016
Date registered
4/04/2016
Date last updated
8/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The "Secret Agent Society: Whole of classroom program", investigating the efficacy of a social skill and emotion regulation focused program for children with autism spectrum disorders, unspecified social and emotional difficulties and typically developing children within a classroom context.
Scientific title
The "Secret Agent Society: Whole of classroom program", investigating the efficacy of a social skill and emotion regulation focused program for children with autism spectrum disorders, unspecified social and emotional difficulties and typically developing children within a classroom context.
Secondary ID [1] 288736 0
Autism CRC Council: CRC2.008RS
Universal Trial Number (UTN)
Trial acronym
SAS:WC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 297975 0
Condition category
Condition code
Mental Health 298133 298133 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
RCT involving grade 5 classrooms, divided into those recieving the intervention and those on a waitlist (control). Intervention is a social skill and emotion regulation program called the 'Secret Agent Society'. It was originally created for children with ASD, but will also be offered to children with unspecified social and emotional issues as well as typically developing children with the intention to investigate whether it is of benefit for these populations as well.

The SAS:WC intervention will comprise of a one hour class run for the duration of a school term (12 weeks in total). Teachers will provide the content to students, with lessons comprising of group work, computer game components, and students working through a "cadet handbook" (a personal workbook for each student). Classes focus on recognising emotion in others and in the self before moving on the strategies aimed that aid in emotion regulation (e.g. what to do when feeling anxious). The waitlist control will provide class as normal.

Teachers recieve two full days of training prior to intervention. Training is run by program creator Dr Renae Beaumont with the aid of Associate Professor Dr Kate Sofronoff (both are clinical psychologists) and Ruby Clarke (a provisional psychologist). Training is intensive and interactive, it is a requirement that those teachers implementing the program in each school attend. It is also the time when resources for the program are provided for the teachers to collect. The program will be taught weekly as a subject for the duration of one school term (12 weeks), with each lesson lasting an hour.

Intervention is measured across three time points: pre, post, and at three month follow up intervention. The teachers have access to support via phone, skype and email with the aforementioned people. The program will be run as a subject in a school semester, participating schools have already made a time in their school week and have signed contracts detailing their committment to the program.

After initial study with grade 5 classrooms in QLD, 2017 will see the expansion of the study to grade 5 schools in other states within Australia while also following the original QLD cohort as they enter grade 6 and finally grade 7 (high school) to ascertain generalizability and duration of skills learned during intervention.
Intervention code [1] 294171 0
Treatment: Other
Intervention code [2] 294172 0
Lifestyle
Intervention code [3] 294173 0
Behaviour
Comparator / control treatment
Control will be education as usual for grade 5 classes.
Control group
Active

Outcomes
Primary outcome [1] 297776 0
Social Skills Questionnaire (Spence, 1995)(teacher form)
Timepoint [1] 297776 0
pre, post and three month follow up
Primary outcome [2] 297777 0
Emotion Regulation and Social Skills Questionnaire (Beaumont & Sofronoff, 2008) (teacher form)
Timepoint [2] 297777 0
pre, post and three month follow up
Secondary outcome [1] 322182 0
Spence Child Anxiety Scale (Spence, 1995) (teacher form) (PRIMARY OUTCOME)
Timepoint [1] 322182 0
pre, post and three month follow up
Secondary outcome [2] 322183 0
Child Adjustment and Parent Efficacy Scale (CAPES; CAPES-DD; Mazzucchelli, Sanders & Morawska, 2010)(teacher form) (PRIMARY OUTCOME)
Timepoint [2] 322183 0
pre, post and three month follow up
Secondary outcome [3] 322184 0
James and the Maths Test (Attwood, 2004) (child form) (PRIMARY OUTCOME). This questionnaire measures a child's emotional intelligence and current skills in emotion regulation. It is used in the context of this study to ascertain a child's current level of function, and whether the responses to this questionnaire change as intervention progresses.
Timepoint [3] 322184 0
pre, post and three month follow up
Secondary outcome [4] 322185 0
Dylan is Being Teased (Attwood, 2006)(child form)(PRIMARY OUTCOME). This questionnaire asks children to generate several options on how to cope with bullying. It is used in the context of this study as a means to investigate whether to intervention increases and improves responses to this measure.
Timepoint [4] 322185 0
pre, post and three month follow up
Secondary outcome [5] 322186 0
Friendship Mapping (Kasari, 2012) (child form) (PRIMARY OUTCOME)
Timepoint [5] 322186 0
pre, post and three month follow up
Secondary outcome [6] 322187 0
The Bullying Prevalence Questionnaire (Rigby & Slee, 1993) (child form) (PRIMARY OUTCOME)
Timepoint [6] 322187 0
pre, post and three month follow up
Secondary outcome [7] 322188 0
Satisfaction with the program (teacher and child forms) designed specifically for the program
Timepoint [7] 322188 0
post intervention
Secondary outcome [8] 322288 0
Grade 6 and 7 follow up. The students identified in the current grade 5 classes to possess a verified ASD diagnosis will be followed through into grade 6 and finally into grade 7 to assess whether the the effects of the program (if any) have been maintained. At this stage, an assessment battery for this has yet to be devised - expected to be completed beginning of 2017. However, it should closely resemble the assessment battery used for the current QLD grade 5 cohort.
Timepoint [8] 322288 0
Grade 6 (one year post intervention) and grade 7 (two years post intervention) (for ASD students only).
Secondary outcome [9] 322400 0
The BASC-111 (teacher form) (PRIMARY OUTCOME)
Timepoint [9] 322400 0
pre, post and three month follow up

Eligibility
Key inclusion criteria
Grade 5 classrooms in QLD who have at least 1 child with a verified diagnosis of ASD within their class and who are willing to participate in the program. In the next few years the study will expand to incorporate grade 5 classrooms in other states within Australia, as well as follow the original grade 5 classes in QLD as they transition into high school.
Minimum age
9 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participant would only be excluded if parents did not give consent for the data of their child to be used in the program (child would still participate in SAS:WC but the data would not be recorded). Exclusion may also be possible if the class were to no longer have a student with ASD in their cohort.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
16/10/2015
Date of last participant enrolment
Anticipated
4/03/2016
Actual
4/03/2016
Date of last data collection
Anticipated
4/12/2017
Actual
Sample size
Target
400
Accrual to date
Final
443
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 293095 0
Other
Name [1] 293095 0
Autism CRC
Country [1] 293095 0
Australia
Funding source category [2] 293096 0
University
Name [2] 293096 0
University of Queensland
Country [2] 293096 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Kate Sofronoff
Address
School of Psychology
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Australia
Country
Australia
Secondary sponsor category [1] 291882 0
Individual
Name [1] 291882 0
Ruby Clarke
Address [1] 291882 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Australia
Country [1] 291882 0
Australia
Secondary sponsor category [2] 292005 0
Individual
Name [2] 292005 0
Dr Renae Beaumont
Address [2] 292005 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Australia
Country [2] 292005 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294641 0
University of Queensland
Ethics committee address [1] 294641 0
Ethics committee country [1] 294641 0
Australia
Date submitted for ethics approval [1] 294641 0
Approval date [1] 294641 0
11/05/2015
Ethics approval number [1] 294641 0
2015000567

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

Contacts
Principal investigator
Name 64278 0
A/Prof Kate Sofronoff
Address 64278 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Australia
Country 64278 0
Australia
Phone 64278 0
+61 7 3365 6411
Fax 64278 0
Email 64278 0
[email protected]
Contact person for public queries
Name 64279 0
Ruby Clarke
Address 64279 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Australia
Country 64279 0
Australia
Phone 64279 0
+61439045435
Fax 64279 0
Email 64279 0
[email protected]
Contact person for scientific queries
Name 64280 0
Kate Sofronoff
Address 64280 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Australia
Country 64280 0
Australia
Phone 64280 0
+61 7 3365 6411
Fax 64280 0
Email 64280 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.