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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Autism Spectrum Disorder

Condition category

Condition code

Neurological

Other neurological disorders

Mental Health

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]

Treatment: Other

Intervention code [2]

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]

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]

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]

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]

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]

Cambridge Mind Reading For Complex emotions

Timepoint [2]

Secondary outcome [3]

Paediatric Quality of life Inventory- 4th edition

Timepoint [3]

Secondary outcome [4]

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]

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]

Junior Temperament and Character Inventory (composite outcome)

Timepoint [5]

Secondary outcome [6]

Social responsiveness scale - second edition

Timepoint [6]

Secondary outcome [7]

Child health Utility 9D measuring quality adjusted life years

Timepoint [7]

Secondary outcome [8]

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]

Secondary outcome [9]

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]

Everyday from Start of intervention (week0) to the follow up time point (36 weeks)

Secondary outcome [10]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6008 - Shenton Park

Recruitment postcode(s) [2]

6056 - Midland

Recruitment postcode(s) [3]

6158 - East Fremantle

Recruitment postcode(s) [4]

6027 - Joondalup

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Stan Perron Charitable Trust

Address [1]

4 Plain street, East Perth, WA, 6004

Country [1]

Australia

Primary sponsor type

University

Name

Curtin University

Address

Kent Street, Bentley, Perth, Western Australia 6102

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

Autism Association of Western Australia

Address [1]

215 Stubbs terrace, Shenton Park, Perth, WA, 6008

Country [1]

Australia

Other collaborator category [1]

Other

Name [1]

Karolinska Institute - Center for Neurodevelopmental Disorders at Karolinska Institute (KIND)

Address [1]

CAP Research Center
Gävlegatan 22 (Entré B), floor 8
SE-11330 Stockholm, Sweden

Country [1]

Sweden

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Human Research Ethics Committee Office of Research and Development

Ethics committee address [1]

GPO Box U1987, Perth Western Australia 6845

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/03/2019

Approval date [1]

18/03/2019

Ethics approval number [1]

HRE2017-0245

Summary

Brief summary

Individuals diagnosed with ASD experience persisting deficits in social communication and social interaction across multiple contexts. They experience high levels of social anxiety, loneliness and isolation, despite a strong desire for friends. It is likely that many of these children have much to gain from social skills training. KONTAKT(c) is a manualized Social Skills Training Group (SSTG) program designed for children and adolescents with ASD which has demonstrated improvements in social skills, behaviour, reduced stress and improved overall functioning as reported by parents immediately following and at three months after the program.  However, social skills are at least in part influenced by social cultural contexts so the aim of the current project is to develop and evaluate the effectiveness of a social skills group training intervention, KONTAKT(c), for Australian Children with ASD.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Sonya Girdler

Address

Curtin University, School of occupational therapy and social works, Building 104, Kent street, Bentley, WA, 6102

Country

Australia

Phone

+61 8 9266 3630

Fax

[email protected]

Contact person for public queries

Name

Bahareh Afsharnejad

Address

Curtin Autism Research Group, Building 603, Technology Park, Kent street, Bentley, WA, 6102

Country

Australia

Phone

+61 435 717 813

Fax

[email protected]

Contact person for scientific queries

Name

Sonya Girdler

Address

Curtin University, School of occupational therapy and social works, Building 104, Kent street, Bentley, WA, 6102

Country

Australia

Phone

+61 8 9266 3630

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Email	Other Details	Attachment
2970	Study protocol	[email protected]	This will be provided in the form of a journal art... [More Details]
2971	Informed consent form			377890-(Uploaded-10-07-2019-11-45-21)-Study-related document.docx
2972	Ethical 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.

Trial Review

Documents added manually

Documents added automatically