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Trial registered on ANZCTR


Registration number
ACTRN12619000994189
Ethics application status
Approved
Date submitted
1/07/2019
Date registered
12/07/2019
Date last updated
12/07/2019
Date data sharing statement initially provided
12/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Social Groups for Australian Children on the Autism Spectrum
Scientific title
The Development and Evaluation of a Social Skills Group Training for goal achievement in Australian Children on the Autism Spectrum
Secondary ID [1] 298634 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 313506 0
Condition category
Condition code
Neurological 311938 311938 0 0
Other neurological disorders
Mental Health 311939 311939 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
KONTAKT(c) is a manualized Social skills group training program designed for children and adolescents with Autism Spectrum Disorders (ASD) aimed at improving communication, social interaction skills, the severity of ASD symptoms, and the ability to empathise and adapt in a group setting. The KONTAKT(c) participants (4-8 participants) meet face to face weekly for 16 weeks for an hour in a group facilitated by two trainers. Sessions are structured according to principals of cognitive behaviour therapy, behaviour activation, observational learning, psychoeducation and social cognition training. Sessions scaffold knowledge of common social rules and norms, aiming to promote problem solving strategies, emotion recognition and emotion expression. The structure of the program is as follows:
Opening round, Reviewing the homework, themed discussion, group activities, snack time, Assigning new homework, and the closing round.
The participants will have 20 minutes of homework per week
Group activity examples are: Charades, Whispering game, EU-motion (practicing facial expressions on computer using whole-body or face area only), Spin the bottle (with/without a theme), What has changed? Alphabet sentences, Role play (including selection of theme for the ”role play”), Treasure hunt, Blinking game, Joint activity (e.g. baking), Advanced treasure hunt, Stress management: breathing square.

Facilitators are trained and have sufficient expertise and clinical experience in working with children with ASD (psychologist, occupational therapist, social worker, doctor, special education, etc.). They should have experience in leading groups.

The trainers will receive extensive training for 2 full days in methods of delivering KONTAKT(c). TH training will be held in January 2020 by 2 Swedish psychologists with expertise in delivering KONTAKT(c). To be considered an expert KONTAKT(c) trainer, they will need to submit video recordings of them delivering the program to a group of children on the autism spectrum, before the trial begins in second half of 2020. They also will be receiving ongoing supervision while delivering the program. In addition to a trainer's manual, the trainers will receive a Fidelity scale to make sure they are following the KONTAKT(c) program.
Intervention code [1] 314897 0
Treatment: Other
Intervention code [2] 314931 0
Behaviour
Comparator / control treatment
Children allocated to the control group will receive a manualized cooking program in groups of 6-8, for one hour per week, for 16 weeks over two school terms. The intervention will be delivered by 2 therapists with experience in working with children with ASD. This group will serve as an active control.
Control group
Active

Outcomes
Primary outcome [1] 320596 0

Children's primary outcome: Goal Attainment Scale. Using the scale the participants personally meaningful social goals will be specified, and a behavioural expectation that ranges from the worst to the best possible outcome will be listed for each goal. This allows qualitative data to be quantified in relation to the success of the participant in achieving expectations of change.
Timepoint [1] 320596 0
Baseline (time point 1-week0): Following screening, and prior to randomization to the Intervention (KONTAKT(c)) or the Control group (Cooking group).
Post-test (time point 2 - week 20): After the program (KONTAKT(c)) or the Control group (Cooking group) has ended
follow-up (time point 3- week 36): 16 weeks following post-test
Secondary outcome [1] 372160 0
Emotion Regulation and Social Skills Questionnaire is a composite measureaAssessing e frequencies of effective engagement in social behaviours and the competency of these skills
Timepoint [1] 372160 0
Baseline: Following screening, and prior to randomization to the Intervention (KONTAKT(c)) or the Control group (Cooking group). (week 0)
Time point two (post-test): Following 16 weeks of intervention (week 20)
Time point three (follow-up): 16 weeks following post-test (week 36)
Secondary outcome [2] 372161 0
Cambridge Mind Reading For Complex emotions
Timepoint [2] 372161 0
Baseline: Following screening, and prior to randomization to the Intervention (KONTAKT(c)) or the Control group (Cooking group). (week 0)
Time point two (post-test): Following 16 weeks of intervention (week 20)
Time point three (follow-up): 16 weeks following post-test (week 36)
Secondary outcome [3] 372162 0

Paediatric Quality of life Inventory- 4th edition
Timepoint [3] 372162 0
Baseline: Following screening, and prior to randomization to the Intervention (KONTAKT(c)) or the Control group (Cooking group). (week 0)
Time point two (post-test): Following 16 weeks of intervention (week 20)
Time point three (follow-up): 16 weeks following post-test (week 36)
Secondary outcome [4] 372163 0
Negative incidents and effects of psychological treatment: This is a 32 item composite questionnaire that measures the views on positive and negative Incidents and effects which can occur during treatment
Timepoint [4] 372163 0
Time point two (post-test): Following 16 weeks of intervention (week 20)
Time point three (follow-up): 16 weeks following post-test (week 36)
Secondary outcome [5] 372164 0
Junior Temperament and Character Inventory (composite outcome)
Timepoint [5] 372164 0
Baseline: Following screening, and prior to randomization to the Intervention (KONTAKT(c)) or the Control group (Cooking group). (week 0)
Time point two (post-test): Following 16 weeks of intervention (week 20)
Time point three (follow-up): 16 weeks following post-test (week 36)
Secondary outcome [6] 372165 0
Social responsiveness scale - second edition
Timepoint [6] 372165 0
Baseline: Following screening, and prior to randomization to the Intervention (KONTAKT(c)) or the Control group (Cooking group). (week 0)
Time point two (post-test): Following 16 weeks of intervention (week 20)
Time point three (follow-up): 16 weeks following post-test (week 36)
Secondary outcome [7] 372166 0
Child health Utility 9D measuring quality adjusted life years
Timepoint [7] 372166 0

Baseline: Following screening, and prior to randomization to the Intervention (KONTAKT(c)) or the Control group (Cooking group). (week 0)
Time point two (post-test): Following 16 weeks of intervention (week 20)
Time point three (follow-up): 16 weeks following post-test (week 36)
Secondary outcome [8] 372167 0

Treatment Inventory of Costs in patients (TIC-P) examining health care usage as well as any work, education and productivity losses incurred by participants and their carers
Timepoint [8] 372167 0
Baseline: Following screening, and prior to randomization to the Intervention (KONTAKT(c)) or the Control group (Cooking group). (week 0)
Time point two (post-test): Following 16 weeks of intervention (week 20)
Time point three (follow-up): 16 weeks following post-test (week 36)
Secondary outcome [9] 372168 0
Experience Sampling Method from participants asking them on a scale of 1-10 how they have been feeling (happy, unlonely, calm, unafraid and confident)
Timepoint [9] 372168 0
Everyday from Start of intervention (week0) to the follow up time point (36 weeks)
Secondary outcome [10] 372169 0
International classification of Functioning - Autism Spectrum Disorder Coresets, evaluating the impact of a disability and its context on an individual’s functioning through interview and card sorting
Timepoint [10] 372169 0

Baseline: Following screening, and prior to randomization to the Intervention (KONTAKT(c)) or the Control group (Cooking group). (week 0)
Time point two (post-test): Following 16 weeks of intervention (week 20)
Time point three (follow-up): 16 weeks following post-test (week 36)

Eligibility
Key inclusion criteria
Individuals aged 8 to 12 (school grade 2-6)
Clinical consensus diagnosis of ASD as defined by DSM-5 and confirmed by the Autism Diagnostic Observation schedule-2
IQ scores > 70 as measured by the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II)
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Existing prior comorbid externalizing behaviours as assessed by the Childhood Behaviour Checklist (CBCL).
Clinically assessed self-injurious behaviour
Low intrinsic motivation to participate in a social skills training group
Insufficient English language skills

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)
The allocation to study group is done after screening, and baseline assessment by Autism Association of WA and An assessor from the research team and participants will be blind to group allocation.
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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

96 participants will be recruited from an existing waitlist list at AAWA of approximately 300 Children diagnosed with ASD based in the inclusion and exclusion criteria. This sample will be representative of the children served by the AAWA. Based on findings from a previous study which evaluated the effectiveness of KONTAKT(c) in children with ASD and employed the Social Responsive scale – second edition (SRS-2) as the primary outcome measure, a minimum of N=56 participants would be required to detect an effect size of 0.2 with a power of 0.9 at a conventional error probability (a=5%) which according to Cohen detects even small to medium effects. In the proposed study the Goal Attainment Scaling (GAS) will be the primary outcome measure and a further power calculation will be undertaken based on findings from the pilot study. However, based on previous studies of KONTAKT(c) a sample size of 96 participants should permit significant findings to be identified.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2019
Actual
Date of last participant enrolment
Anticipated
30/07/2021
Actual
Date of last data collection
Anticipated
31/03/2022
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 26934 0
6008 - Shenton Park
Recruitment postcode(s) [2] 26935 0
6056 - Midland
Recruitment postcode(s) [3] 26936 0
6158 - East Fremantle
Recruitment postcode(s) [4] 26937 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 303174 0
Charities/Societies/Foundations
Name [1] 303174 0
Stan Perron Charitable Trust
Country [1] 303174 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, Perth, Western Australia 6102
Country
Australia
Secondary sponsor category [1] 303183 0
Other
Name [1] 303183 0
Autism Association of Western Australia
Address [1] 303183 0
215 Stubbs terrace, Shenton Park, Perth, WA, 6008
Country [1] 303183 0
Australia
Other collaborator category [1] 280828 0
Other
Name [1] 280828 0
Karolinska Institute - Center for Neurodevelopmental Disorders at Karolinska Institute (KIND)
Address [1] 280828 0
CAP Research Center
Gävlegatan 22 (Entré B), floor 8
SE-11330 Stockholm, Sweden
Country [1] 280828 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303736 0
Curtin University Human Research Ethics Committee Office of Research and Development
Ethics committee address [1] 303736 0
Ethics committee country [1] 303736 0
Australia
Date submitted for ethics approval [1] 303736 0
01/03/2019
Approval date [1] 303736 0
18/03/2019
Ethics approval number [1] 303736 0
HRE2017-0245

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

Contacts
Principal investigator
Name 94618 0
Prof Sonya Girdler
Address 94618 0
Curtin University, School of occupational therapy and social works, Building 104, Kent street, Bentley, WA, 6102
Country 94618 0
Australia
Phone 94618 0
+61 8 9266 3630
Fax 94618 0
Email 94618 0
sonya.girdler@curtin.edu.au
Contact person for public queries
Name 94619 0
Bahareh Afsharnejad
Address 94619 0

Curtin Autism Research Group, Building 603, Technology Park, Kent street, Bentley, WA, 6102
Country 94619 0
Australia
Phone 94619 0
+61 435 717 813
Fax 94619 0
Email 94619 0
bahareh.afsharnejad@curtin.edu.au
Contact person for scientific queries
Name 94620 0
Sonya Girdler
Address 94620 0
Curtin University, School of occupational therapy and social works, Building 104, Kent street, Bentley, WA, 6102
Country 94620 0
Australia
Phone 94620 0
+61 8 9266 3630
Fax 94620 0
Email 94620 0
sonya.girdler@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is part of the ethics submitted that the IPD for this study cannot be shared.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2970Study protocol  bahareh.afsharnejad@curtin.edu.au This will be provided in the form of a journal art... [More Details]
2971Informed consent form    377890-(Uploaded-10-07-2019-11-45-21)-Study-related document.docx
2972Ethical approval    377890-(Uploaded-10-07-2019-11-53-21)-Study-related document.pdf



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.