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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03294668




Registration number
NCT03294668
Ethics application status
Date submitted
22/09/2017
Date registered
27/09/2017

Titles & IDs
Public title
KONTAKT Australia a Social Skills Group Training for Adolescents on the Autism Spectrum
Scientific title
Developing and Evaluating a Social Skills Group Training for Adolescents on the Autism Spectrum
Secondary ID [1] 0 0
HRE2017-0245
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - KONTAKT Australia
Other interventions - Super Chef

Experimental: KONTAKT Australia - A social skills group training

Active comparator: Super Chef - A social cooking group


BEHAVIORAL: KONTAKT Australia
KONTAKT is a manualized Social skills group training program designed for children and adolescents on the Autism Spectrum 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.

Other interventions: Super Chef
The Super Chef is a cooking group designed for this study for adolescents on the Autism Spectrum, aimed at teaching basic cooking skills in a social environment. The Super Chef 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.
Intervention code [1] 0 0
BEHAVIORAL
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in the Goal Attainment Scale (GAS)
Timepoint [1] 0 0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Secondary outcome [1] 0 0
Change in the Emotion Regulation and Social Skills Questionnaire (ERSSQ)
Timepoint [1] 0 0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Secondary outcome [2] 0 0
Mind Reading Battery
Timepoint [2] 0 0
Baseline (week 0), Post-test (week 20) and follow up (week 36)
Secondary outcome [3] 0 0
Change in the Circumplex Scale of Interpersonal Efficacy (CSIE)
Timepoint [3] 0 0
Baseline (week 0), Post-test (week 20) and follow up (week 36)
Secondary outcome [4] 0 0
Change in the Paediatric Quality of life Inventory- 4th edition (PedQL-4.0)
Timepoint [4] 0 0
Baseline (week 0), Post-test (week 20) and follow up (week 36)
Secondary outcome [5] 0 0
Change in the Perth Loneliness Scale (PALs)
Timepoint [5] 0 0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Secondary outcome [6] 0 0
Change in the Negative Incidents and Effects of Psychological Treatment (NEQ)
Timepoint [6] 0 0
Post-test (week 20) and follow up (week 36)
Secondary outcome [7] 0 0
Change in the Child Health Utility 9D (CHU9D)
Timepoint [7] 0 0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Secondary outcome [8] 0 0
Change in Emotions via Experience Sampling (ESM)
Timepoint [8] 0 0
Through the intervention until follow up time from week 1 to 36
Secondary outcome [9] 0 0
Change in Social Interaction Anxiety Scale (SIAS)
Timepoint [9] 0 0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Secondary outcome [10] 0 0
Change in Treatment Inventory of Costs in Patients (TIC-P)
Timepoint [10] 0 0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Secondary outcome [11] 0 0
Change in social functioning
Timepoint [11] 0 0
Time 1 (week 3), Time 2 (week 13 ), Time 3 (week 19)
Secondary outcome [12] 0 0
Treatment Satisfaction Scale
Timepoint [12] 0 0
Post-test (week 20)
Secondary outcome [13] 0 0
Change in the Social responsiveness scale - Second Edition (SRS-2)
Timepoint [13] 0 0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)

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?
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
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/10/2020
Sample size
Target
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Curtin University - Bentley
Recruitment postcode(s) [1] 0 0
6102 - Bentley

Funding & Sponsors
Primary sponsor type
Other
Name
Curtin University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Autism Association of Western Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Karolinska Institutet
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Sonya J Girdler, PhD
Address 0 0
Occupational Therapy Professor - Curtin University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Afsharnejad B, Falkmer M, Black MH, Alach T, Lenha... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT03294668