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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

11/06/2019

Date data sharing statement initially provided

11/06/2019

Date results information initially provided

11/06/2019

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]

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

Condition category

Condition code

Neurological

Other neurological disorders

Mental Health

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]

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]

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 [1]

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]

Emotion Regulation and Social Skills Questionnaire

Timepoint [1]

Secondary outcome [2]

Cambridge Mind Reading For Complex emotions

Timepoint [2]

Secondary outcome [3]

Circumplex Scale of Interpersonal Efficacy

Timepoint [3]

Secondary outcome [4]

Paediatric Quality of life Inventory- 4th edition

Timepoint [4]

Secondary outcome [5]

Social Interaction Anxiety Scale

Timepoint [5]

Secondary outcome [6]

Perth Loneliness Scale

Timepoint [6]

Secondary outcome [7]

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]

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]

Treatment Inventory of Costs in patients (TIC-P)

Timepoint [8]

Secondary outcome [9]

Child health Utility 9D

Timepoint [9]

Secondary outcome [10]

Treatment Satisfaction Scale (TSS-2)

Timepoint [10]

Following 16 weeks of intervention (week 20)

Secondary outcome [11]

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]

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

Secondary outcome [12]

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 [12]

Baseline (time point 1) post-test (time-point 2) and follow-up (time point 3)

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

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 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

Active, not recruiting

Date of first participant enrolment

Anticipated

1/08/2017

Actual

1/08/2017

Date of last participant enrolment

Anticipated

31/01/2019

Actual

31/01/2019

Date of last data collection

Anticipated

31/10/2019

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]

23/03/2017

Approval date [1]

03/05/2017

Ethics approval number [1]

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

Prof Sonya Girdler

Address

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

Mrs 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

Prof Sonya Girdler

Address

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

Country

Australia

Phone

+61 435 717 813

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 for this study.

What supporting documents are/will be available?

Current supporting documents:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2295	Study protocol				https://doi.org/10.21203/rs.2.326/v1

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details
2295	Study protocol	Afsharnejad, B., Falkmer, M., Black, M.H. et al. KONTAKT© for Australian adolescents on the autism spectrum: protocol of a randomized control trial. Trials 20, 687 (2019).	https://rdcu.be/b0Jfn	[email protected]	https://doi.org/10.1186/s13063-019-3721-9
23521	Other	Afsharnejad B., Falkmer M., Picen T., Black M.H., Alach T., Fridell A., Coco C., Milne K., Bölte, S. & Girdler, S. (2021). “I met someone like me!”: Autistic adolescents and their parent’s experience of the KONTAKT® social skills group training. Journal of Autism and Developmental Disorders, https://doi.org/10.1007/s10803-021-05045-1	https://doi.org/10.1007/s10803-021-05045-1	[email protected]	This manuscript describes the findings from the in... [More Details]
23522	Ethical approval			[email protected]	Can be provided upon request.
23523	Clinical study report	Afsharnejad B., Falkmer M., Black M.H., Alach T., Fridell A., Coco C., Milne K., Bölte, S. & Girdler, S. (2021). KONTAKT® social skills group training supports autistic adolescents in achieving their personally meaningful social goals: A randomised actively Controlled Trial. European Child & Adolescent Psychiatry. https://doi.org/10.1007/s00787-021-01814-6	https://doi.org/10.1007/s00787-021-01814-6	[email protected]

Results publications and other study-related documents

Documents added manually

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4053	Plain language summary	No		Findings from this study demonstrated that KONTAKT... [More Details]
4665	Study results article	Yes		Published 30 May 2021 Afsharnejad B., Falkmer M... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	KONTAKT social skills group training for Australian adolescents with autism spectrum disorder: a randomized controlled trial.	2022	https://dx.doi.org/10.1007/s00787-021-01814-6
Embase	"I Met Someone Like Me!": Autistic Adolescents and Their Parents' Experience of the KONTAKT Social Skills Group Training.	2022	https://dx.doi.org/10.1007/s10803-021-05045-1
Embase	Cross-Cultural Adaptation to Australia of the KONTAKT© Social Skills Group Training Program for Youth with Autism Spectrum Disorder: A Feasibility Study.	2020	https://dx.doi.org/10.1007/s10803-020-04477-5

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically