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Trial registered on ANZCTR


Registration number
ACTRN12617001117303
Ethics application status
Approved
Date submitted
24/07/2017
Date registered
31/07/2017
Date last updated
9/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
KONTAKT a Social Skills Group Training Intervention for Teenagers with Autism Spectrum Disorders in Australia
Scientific title
The Development and Evaluation of a Social Skills Group Training Intervention on Social Responsiveness and Goal Attainment in Australian Adolescents with Autism Spectrum Disorders
Secondary ID [1] 291890 0
ClinicalTrials.gov: NCT03294668
Universal Trial Number (UTN)
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 303305 0
Condition category
Condition code
Neurological 302741 302741 0 0
Other neurological disorders
Mental Health 303536 303536 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
KONTAKT 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 participants (4-8 participants) meet face to face weekly for 16 weeks for an hour and a half 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 adolescents with ASD (psychologist, occupational therapist, social worker, doctor, special education, etc.). They should have experience in leading groups.

The trainers have received extensive training for 3 full days in methods of delivering KONTAKT in June. To be considered an expert KONTAKT trainer, they will need to submit video recordings of them delivering the program to a group of Adolescents on the spectrum. which they will have done before the trial begins next year. 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 program.

Before the randomized control trial, there will be three other phases. After delivering the first phase the other 2 phases will run concurrently.
1. Translating the materials from Swedish to Australian English
2. Having focus groups with individuals on the autism spectrum, their parent/carers and therapist regarding social skills groups. A survey with the typically developing Australian adolescents regarding how they usually spend their time.
3. A pilot of the KONTAKT Program
Intervention code [1] 298217 0
Treatment: Other
Comparator / control treatment
Adolescents allocated to the control group will receive a manualized cooking program in groups of 6-8, for one and a half hours per week, for 16 weeks over two school terms. The intervention will be delivered by 2 therapists with experience in working with adolescents with ASD. This group will serve as an active control.
Control group
Active

Outcomes
Primary outcome [1] 302297 0
The Social Responsiveness Scale – Second Edition (SRS-2) School-Age Form is a 65-item rating scale, designed to measure social deficits in individuals with ASD via parent proxy report has been used as the primary outcome in a previous study evaluating KONTAKT and has been used as the basis for the power calculation for the present RCT.
Timepoint [1] 302297 0
Baseline: Following screening, and prior to randomization to the Intervention (KONTAKT) 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)
Primary outcome [2] 302495 0
Adolescents' 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 [2] 302495 0
Baseline: Following screening, and prior to randomization to the Intervention (KONTAKT) 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 [1] 336195 0
Emotion Regulation and Social Skills Questionnaire
Timepoint [1] 336195 0
Baseline: Following screening, and prior to randomization to the Intervention (KONTAKT) 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] 336196 0
Cambridge Mind Reading For Complex emotions
Timepoint [2] 336196 0
Baseline: Following screening, and prior to randomization to the Intervention (KONTAKT) 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] 336197 0
Circumplex Scale of Interpersonal Efficacy
Timepoint [3] 336197 0
Baseline: Following screening, and prior to randomization to the Intervention (KONTAKT) 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] 336198 0
Paediatric Quality of life Inventory- 4th edition
Timepoint [4] 336198 0
Baseline: Following screening, and prior to randomization to the Intervention (KONTAKT) 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 [5] 336199 0
Social Interaction Anxiety Scale
Timepoint [5] 336199 0
Baseline: Following screening, and prior to randomization to the Intervention (KONTAKT) 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] 336200 0
Perth Loneliness Scale
Timepoint [6] 336200 0
Baseline: Following screening, and prior to randomization to the Intervention (KONTAKT) 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] 336201 0
Negative incidents and effects of psychological treatment: This is a 32 item questionnaire that measures the views on positive and negative Incidents and effects which can occur during treatment
Timepoint [7] 336201 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] 336202 0
Treatment Inventory of Costs in patients (TIC-P)
Timepoint [8] 336202 0
Baseline: Following screening, and prior to randomization to the Intervention (KONTAKT) 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] 336203 0
Child health Utility 9D
Timepoint [9] 336203 0
Baseline: Following screening, and prior to randomization to the Intervention (KONTAKT) 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 [10] 349170 0
Treatment Satisfaction Scale (TSS-2)
Timepoint [10] 349170 0
Following 16 weeks of intervention (week 20)
Secondary outcome [11] 349171 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 [11] 349171 0
Everyday from Start of intervention (week0) to the follow up time point (36 weeks)

Eligibility
Key inclusion criteria
Individuals aged 12 to 17
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
12 Years
Maximum age
17 Years
Gender
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 the research team 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 assessing the outcomes
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 700 teenagers diagnosed with ASD based in the inclusion and exclusion criteria. This sample will be representative of the adolescents served by the AAWA. Based on findings from a previous study which evaluated the effectiveness of KONTAKT 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 a sample size of 96 participants should permit significant findings to be identified.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 16473 0
6008 - Shenton Park
Recruitment postcode(s) [2] 16474 0
6056 - Midland
Recruitment postcode(s) [3] 16475 0
6158 - East Fremantle

Funding & Sponsors
Funding source category [1] 296387 0
Charities/Societies/Foundations
Name [1] 296387 0
Stan Perron Charitable Trust
Address [1] 296387 0
4 Plain street, East Perth, WA, 6004
Country [1] 296387 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, Perth, Western Australia 6102
Country
Australia
Secondary sponsor category [1] 295771 0
Other
Name [1] 295771 0
Autism Association of Western Australia
Address [1] 295771 0
215 Stubbs terrace, Shenton Park, Perth, WA, 6008
Country [1] 295771 0
Australia
Other collaborator category [1] 279659 0
Other
Name [1] 279659 0
Karolinska Institute - Center for Neurodevelopmental Disorders at Karolinska Institute (KIND)
Address [1] 279659 0
CAP Research Center
Gävlegatan 22 (Entré B), floor 8
SE-11330 Stockholm, Sweden
Country [1] 279659 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297623 0
Curtin University Human Research Ethics Committee Office of Research and Development
Ethics committee address [1] 297623 0
GPO Box U1987, Perth Western Australia 6845
Ethics committee country [1] 297623 0
Australia
Date submitted for ethics approval [1] 297623 0
23/03/2017
Approval date [1] 297623 0
03/05/2017
Ethics approval number [1] 297623 0
HRE2017-0245

Summary
Brief summary
Adolescents diagnosed with ASD experience persisting deficits in social communication and social interaction across multiple contexts. Contrary to popular belief many children with ASD have insight into their impairments and accurately perceive their social and communication abilities. They experience high levels of social anxiety, loneliness and isolation, despite a strong desire for friends. It is likely that many of these adolescents have much to gain from social skills training. KONTAKT is a manualized Social Skills Training Group (SSTG) program designed for children and adolescents with ASD which aims to improve communication, social interaction skills, reduce the severity of ASD symptoms, improve the ability to empathise and adapt in a group setting. A large randomized controlled trial in Sweden found that adolescents who participated in KONTAKT 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 and there is a need to understand the feasibility, acceptability and effectiveness of KONTAKT in an Australian context.
The aim of the current project is to develop and evaluate the effectiveness of a social skills group training intervention, KONTAKT, for Australian adolescents with ASD. In meeting this overall aim this research will be conducted in four phases, commencing with a needs assessment. Phase two will involve the translation and modification of the original KONTAKT manual, and child and parent workbooks from Swedish to Australian English and to the Australian context, inclusive of appropriate homework. Following pilot testing, evaluating the clinical feasibility and acceptability of KONTAKT Australia, phase four will examine the efficacy of the KONTAKT Australia in a two armed randomized controlled trial in a sample of adolescents with ASD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74626 0
Prof Sonya Girdler
Address 74626 0
School of occupational therapy and social works, Building 104, Kent street, Bentley, WA, 6102
Country 74626 0
Australia
Phone 74626 0
+61 8 9266 3630
Fax 74626 0
Email 74626 0
sonya.girdler@curtin.edu.au
Contact person for public queries
Name 74627 0
Mrs Bahareh Afsharnejad
Address 74627 0
Curtin Autism Research Group, Building 603, Technology Park, Kent street, Bentley, WA, 6102
Country 74627 0
Australia
Phone 74627 0
+61 435 717 813
Fax 74627 0
Email 74627 0
bahareh.afsharnejad@postgrad.curtin.edu.au
Contact person for scientific queries
Name 74628 0
Prof Sonya Girdler
Address 74628 0
School of occupational therapy and social works, Building 104, Kent street, Bentley, WA, 6102
Country 74628 0
Australia
Phone 74628 0
+61 435 717 813
Fax 74628 0
Email 74628 0
sonya.girdler@curtin.edu.au

No data has been provided for results reporting
Summary results
Not applicable