Trial Review

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
ACTRN12613000591752
Ethics application status
Approved
Date submitted
21/05/2013
Date registered
24/05/2013
Date last updated
24/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of individually delivered Secret Agent Society: A multi-component social skills intervention for children with Asperger syndrome
Scientific title
In children aged 8-12 years with Asperger Syndrome, is the Secret Agent Society social skills intervention program effective in improving social skills, emotion regulation, emotion management strategies, social perception and self-report popularity.
Secondary ID [1] 282550 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social skills deficits 289219 0
Asperger's syndrome 289251 0
Condition category
Condition code
Mental Health 289555 289555 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Secret Agent Society (SAS) program (Beaumont, 2010a) is a multi-component social skills intervention program for children aged 8 to 12 years old with Asperger Syndrome (AS). It was specifically designed as a group intervention to improve children’s emotional understanding and social skills through weekly group sessions, parent training, teacher tip sheets and a multi-level computer game (Beaumont, 2010a). Current study will be evaluating the SAS program delivered individually. The manualised program comprises of an initial parent information session and 9 weekly 75-minute sessions. Both parents can attend all sessions, including the parent information session, with the child. The graduate psychology student administering the program will spend the first 60 minutes of each session engaging the child in various therapeutic games and activities. This will be followed by a 15-minute review of the program content to the parent. Tips on how parents can support their child in honing their social skills will be discussed. Weekly tip sheets will also be provided through the parents to teachers so that their social skills in school will also be reinforced. Parents and teachers will be required to complete weekly home-school diaries to monitor their child's social skills and to reward their efforts at applying learnt skills.
Intervention code [1] 287219 0
Behaviour
Comparator / control treatment
The current study employs a single-case design that typically involves the use of a small sample number of participants to study behaviour modification and therapy across a diverse population (Fitzgerald, Matson, & Barker, 2011). Single-case designs are common in Autism research. Each participant in single-case research designs is the unit of analysis and serves as his/her own control by participating in all conditions (e.g., the baseline, intervention and follow-up conditions as proposed in the current study).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289644 0
Total score on The Social Skills Questionnaires (SSQ) - Parent (SSQ-P) and teacher (SSQ-T) (Spence, 1995a)
Timepoint [1] 289644 0
pre-baseline (a week prior to baseline observations), pre-intervention (a week prior to intervention), mid-intervention (5 weeks), post-intervention(10 weeks), and at 6 weeks after intervention completion
Primary outcome [2] 289645 0
Total Score on The Emotional Regulation and Social Skills Questionnaire (ERSSQ) - Parent (ERSSQ-P) and Teacher (ERSSQ-T) (Beaumont & Sofronoff, 2008; Butterworth et al., submitted)
Timepoint [2] 289645 0
pre-baseline (a week prior to baseline observations), pre-intervention (a week prior to intervention), mid-intervention (5 weeks), post-intervention(10 weeks), and at 6 weeks after intervention completion
Primary outcome [3] 289646 0
Total score on The Child and Adolescent Social Perception measure (Magill-Evans, Koning, Cameron-Sadava, & Manyk, 1995)
Timepoint [3] 289646 0
pre-baseline (a week prior to baseline observations), pre-intervention (a week prior to intervention), mid-intervention (5 weeks), post-intervention(10 weeks), and at 6 weeks after intervention completion
Secondary outcome [1] 302936 0
Total number of strategies on James and the Maths Test (Attwood, 2004a)
Timepoint [1] 302936 0
pre-baseline (a week prior to baseline observations), pre-intervention (a week prior to intervention), mid-intervention (5 weeks), post-intervention(10 weeks), and at 6 weeks after intervention completion
Secondary outcome [2] 302937 0
Total number of strategies onDylan is Being Teased (Attwood, 2004b)
Timepoint [2] 302937 0
pre-baseline (a week prior to baseline observations), pre-intervention (a week prior to intervention), mid-intervention (5 weeks), post-intervention(10 weeks), and at 6 weeks after intervention completion
Secondary outcome [3] 302938 0
Total score on Piers-Harris Self-Concept Scale (PHS; Piers, 1984)
Timepoint [3] 302938 0
pre-baseline (a week prior to baseline observations), pre-intervention (a week prior to intervention), mid-intervention (5 weeks), post-intervention(10 weeks), and at 6 weeks after intervention completion
Secondary outcome [4] 302939 0
Observational Measure

An observational coding tool was developed based on 2 existing rating scales (Beaumont, 2010: Barry et al., 2003) for assessing social skills of children with AS. The observational coding tool consists of 10 and 12 relevant items respectively selected from Barry and colleagues’ (2003) and Beaumont’s (2010) rating scales, and covers 3 broad domains: non-verbal communication, cooperation and conversation, and conflict resolution.

The child and his/her sibling will be observed on a weekly basis. Children will choose a game from those prepared by the psychology graduate student and they will play the chosen game for 10 minutes. These observation sessions will be videotaped for later scoring using the observational coding tool.
Timepoint [4] 302939 0
Throughout baseline, intervention and 6-week follow up

Eligibility
Key inclusion criteria
The inclusion criteria are: (a) an AS diagnosis confirmed by a paediatrician, (b) a WASI-II pro rated IQ score of 85 or above, (c) aged between 8 and 12 years, (d) the ability to read English, (e) have a typically developing sibling aged 8 to 12 years, (f) not participating in any psychotherapy or other interventions over the course of the study, and (g) parents with DASS-21 scores within normal or mild range and Parenting Scale total score of less than 3.2.
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
N/A

Study design
Purpose of the study
Educational / counselling / training
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The study is a multiple baseline across subjects design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size: According to Matson (2012), one participant is not sufficient to demonstrate treatment efficacy in a single-case research design, rather a replication of results across two or three cases would enhance reliability of the study. Each participant will act as his/her own control by participating in the baseline, intervention and follow-up conditions. Meta analysis (McConnell, 2002) examining the effects of interventions among children with Autism Spectrum Disorder has primarily reviewed studies with 3 or more participants; hence the current study is proposing a sample size of 3.

Data Analysis: Outcome measures will be analysed by computing a reliable change (RC) score for each participant. Computation of the RC score requires estimates of the outcome’s reliability and variability for a population of children with Asperger syndrome. These estimates can be obtained from previous studies (Beaumont & Sofronoff, 2008; Butterworth et al., submitted; Koning et al., in press). An RC score of 1.96 or greater is considered to reflect a reliable change (Jacobson & Traux, 1991). Observational data will be tested using the split-middle line method in conjunction with the binomial test (Portney & Watkin, 2000).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2013
Actual
Date of last participant enrolment
Anticipated
19/07/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 6911 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 287333 0
Other
Name [1] 287333 0
Social Skills Training Institute, a division of Triple P International Pty Ltd.
Country [1] 287333 0
Australia
Funding source category [2] 287334 0
University
Name [2] 287334 0
Curtin University
Country [2] 287334 0
Australia
Primary sponsor type
Individual
Name
Dr Trevor Mazzucchelli
Address
Curtin University
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 286080 0
Individual
Name [1] 286080 0
Lynette Tan
Address [1] 286080 0
Curtin University
Kent St, Bentley WA 6102
Country [1] 286080 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289307 0
Human Research Ethics Committee (HREC)
Ethics committee address [1] 289307 0
Office of Research and Development
PO Box U1987
Perth WA 6845
Ethics committee country [1] 289307 0
Australia
Date submitted for ethics approval [1] 289307 0
15/04/2013
Approval date [1] 289307 0
22/05/2013
Ethics approval number [1] 289307 0
HR60/2013

Summary
Brief summary
The current study will trial the effectiveness of the Secret Agent Society (SAS) program delivered individually to children with Asperger syndrome. Originally designed as a group-based intervention, SAS has been found to result in a variety of benefits for children including improvements in their social skills, ability to regulate their emotions and knowledge in dealing with bullying and teasing. As such, it is anticipated that the individually delivered SAS protocol adopted in this study will result in similar improvements. Results from the study is expected to increase practitioners’ and parent’s confidence in delivering SAS individually to children and potentially increase the intervention’s reach.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40266 0
Dr Trevor Mazzucchelli
Address 40266 0
Curtin University
Kent St, Bentley WA 6102
Country 40266 0
Australia
Phone 40266 0
+618 92667182
Fax 40266 0
Email 40266 0
[email protected]
Contact person for public queries
Name 40267 0
Miss Lynette Tan
Address 40267 0
Curtin University
Kent St, Bentley WA 6102
Country 40267 0
Australia
Phone 40267 0
+61413897271
Fax 40267 0
Email 40267 0
[email protected]
Contact person for scientific queries
Name 40268 0
Dr Trevor Mazzucchelli
Address 40268 0
Curtin University
Kent St, Bentley WA 6102
Country 40268 0
Australia
Phone 40268 0
+618 92667182
Fax 40268 0
Email 40268 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.