Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
Query!
Scientific title
Developing and Evaluating a Social Skills Group Training for Adolescents on the Autism Spectrum
Query!
Secondary ID [1]
0
0
HRE2017-0245
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder
0
0
Query!
Condition category
Condition code
Mental Health
0
0
0
0
Query!
Autistic spectrum disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
BEHAVIORAL
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change in the Goal Attainment Scale (GAS)
Query!
Assessment method [1]
0
0
The GOAL Attainment Scale will be used as the adolescents' primary outcome. 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.
Query!
Timepoint [1]
0
0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Query!
Secondary outcome [1]
0
0
Change in the Emotion Regulation and Social Skills Questionnaire (ERSSQ)
Query!
Assessment method [1]
0
0
The parents will fill this questionnaire (Parent form). This is a 27-item measure assessing emotion regulation and competency in social skills.The questionnaire is designed to measure frequencies of effective engagement in social behaviours (e.g. "chooses appropriate solutions to social problems" or "deals effectively with bullying"), examining the competency of these skills. Responses are rated on a 5-point Likert scale, ranging from "never (0)" to "always (4)", yielding a total score of 0-108, with higher scores indicating higher competencies in social behaviour.
Query!
Timepoint [1]
0
0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Query!
Secondary outcome [2]
0
0
Mind Reading Battery
Query!
Assessment method [2]
0
0
The adolescents will fill this questionnaire. Emotions are displayed in the form of 2-5 second silent coloured video clips, with 4 multiple choice options one of which is the correct emotion label and 3 are distractor items. The distracter options were randomly selected from the entire Mind reading battery emotion groups, excluding the emotion group the target stimuli originates from. Further details of the stimuli are outlined in table 4. During the presentation of stimuli, eye tracking data will be recorded via a Remote Eye Tracker Device (RED) developed by SensoMotoric Instruments, enabling examination of fixation patterns and fixation durations.
Query!
Timepoint [2]
0
0
Baseline (week 0), Post-test (week 20) and follow up (week 36)
Query!
Secondary outcome [3]
0
0
Change in the Circumplex Scale of Interpersonal Efficacy (CSIE)
Query!
Assessment method [3]
0
0
The adolescents will fill this questionnaire. It measures an individual's confidence in regard to their ability to successfully perform behaviours associated with each facet of the interpersonal Circumplex (Assert, Distance, Yield, and Connect). Each octant scale shows a progressive blend of two axial dimensions (e.g. "speak up" representing an assertive action, "get them to leave me alone" a distancing action, and "tell them when I am annoyed" combining these two actions).
Query!
Timepoint [3]
0
0
Baseline (week 0), Post-test (week 20) and follow up (week 36)
Query!
Secondary outcome [4]
0
0
Change in the Paediatric Quality of life Inventory- 4th edition (PedQL-4.0)
Query!
Assessment method [4]
0
0
The adolescents and parents (parent proxy) both will fill this questionnaire. It is a 23-item parent proxy report and an adolescent self-report measure of adolescent's quality of life underpinned by the four subscales of physical, emotional, social, and school functioning. Responders rate items according to if they have been a problem for them on a 5-point Likert scale ranging from "never (0)" to "almost always (5)", with lower scores indicating better quality of life.
Query!
Timepoint [4]
0
0
Baseline (week 0), Post-test (week 20) and follow up (week 36)
Query!
Secondary outcome [5]
0
0
Change in the Perth Loneliness Scale (PALs)
Query!
Assessment method [5]
0
0
The adolescents will fill this questionnaire. This is a self-report measure consisting of 24 statements such as ''I feel left out of things at school'', or ''I get along with my classmates'', measuring four dimensions of loneliness in young people (isolation, friendship and positive and negative attitudes toward solitude).
Query!
Timepoint [5]
0
0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Query!
Secondary outcome [6]
0
0
Change in the Negative Incidents and Effects of Psychological Treatment (NEQ)
Query!
Assessment method [6]
0
0
The adolescents will fill this questionnaire. The NEQ is a 32-item questionnaire requiring adolescents to quantify, on 5-point Likert scale with response options ranging from "Not at all" to "Extremely", any negative events experienced during the intervention period, asking participants to attribute their causality to either the program or external circumstances
Query!
Timepoint [6]
0
0
Post-test (week 20) and follow up (week 36)
Query!
Secondary outcome [7]
0
0
Change in the Child Health Utility 9D (CHU9D)
Query!
Assessment method [7]
0
0
The adolescents will fill this questionnaire. This is a 9-dimension Health related quality of life scale (worried, sad, pain, tired, annoyed, school work, sleep, daily routines and activities), designed to estimate the adolescent's Quality adjusted life years (QALY), providing a standardized measure of disease burden. The measure is rated on a 5-point scale with a "don't" sentence linked with no problems (e.g. I don't feel sad today) and "very" with the participant experiencing a lot of problems (e.g. I feel very sad). Calculation of an universal score is supported by an adolescent specific scoring algorithm, with 1 representing 'full health' and 0 'death'.
Query!
Timepoint [7]
0
0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Query!
Secondary outcome [8]
0
0
Change in Emotions via Experience Sampling (ESM)
Query!
Assessment method [8]
0
0
The adolescents and parents (parent proxy) will fill this questionnaire. This 5-item measure, specifically designed for the purposes of this study, asks "In the last 24 hours, on a scale of 1 to 10 I have been feeling ..." with answers rated on a 10-point scale regarding five dichotomised emotional sets (sad/happy, lonely/unlonely, angry/calm, scared/unafraid, and anxious/confident).
Query!
Timepoint [8]
0
0
Through the intervention until follow up time from week 1 to 36
Query!
Secondary outcome [9]
0
0
Change in Social Interaction Anxiety Scale (SIAS)
Query!
Assessment method [9]
0
0
The adolescents will fill this questionnaire. This is a 20-item measure assessing adolescents' self-reported anxiety in social situations, via items such as "I become tense if I have to talk about myself" or "I find it easy to make friends my own age". Items are rated on a 5-point scale ranging from "Not at all" to "extremely". Total scores range from 0 to 80 with higher scores indicating greater anxiety in social situations
Query!
Timepoint [9]
0
0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Query!
Secondary outcome [10]
0
0
Change in Treatment Inventory of Costs in Patients (TIC-P)
Query!
Assessment method [10]
0
0
The parents will fill this questionnaire (Parent form). This will be measured via a tailored version of the Trimbos/iMTA questionnaire for patients with a psychiatric disorder (TiC-P), a well-established questionnaire examining health care usage as well as any work, education and productivity losses incurred by participants and their carers. The modified version of the TIC-P employed in this study comprise six sections enquiring about health care visits, support received both at and outside of school, medications and supplements, work, and education and productivity losses incurred by both parents and adolescents.
Query!
Timepoint [10]
0
0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Query!
Secondary outcome [11]
0
0
Change in social functioning
Query!
Assessment method [11]
0
0
This will be assessed by a blinded assessor
Query!
Timepoint [11]
0
0
Time 1 (week 3), Time 2 (week 13 ), Time 3 (week 19)
Query!
Secondary outcome [12]
0
0
Treatment Satisfaction Scale
Query!
Assessment method [12]
0
0
The adolescents and parents both will fill this questionnaire. This is a short 6-item parent and adolescents self-report instrument, measuring satisfaction with group attendance. Each item is scored on a 4-point Likert scale with response options ranging from "Yes, very much" to "No" with an open comment section, encouraging participants to freely share their experiences with the intervention.
Query!
Timepoint [12]
0
0
Post-test (week 20)
Query!
Secondary outcome [13]
0
0
Change in the Social responsiveness scale - Second Edition (SRS-2)
Query!
Assessment method [13]
0
0
This measure will be used as the parent's primary outcome.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.
Query!
Timepoint [13]
0
0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Query!
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)
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
17
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/02/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
25/10/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
90
Query!
Recruitment in Australia
Recruitment state(s)
WA
Query!
Recruitment hospital [1]
0
0
Curtin University - Bentley
Query!
Recruitment postcode(s) [1]
0
0
6102 - Bentley
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Curtin University
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Autism Association of Western Australia
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
Karolinska Institutet
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study evaluates the KONTAKT social skills group training in Australian adolescents on the autism spectrum compared to an active control group which is a group cooking class
Query!
Trial website
https://clinicaltrials.gov/study/NCT03294668
Query!
Trial related presentations / publications
Afsharnejad B, Falkmer M, Black MH, Alach T, Lenhard F, Fridell A, Coco C, Milne K, Chen NTM, Bolte S, Girdler S. Cross-Cultural Adaptation to Australia of the KONTAKT(c) Social Skills Group Training Program for Youth with Autism Spectrum Disorder: A Feasibility Study. J Autism Dev Disord. 2020 Dec;50(12):4297-4316. doi: 10.1007/s10803-020-04477-5. Afsharnejad B, Falkmer M, Black MH, Alach T, Lenhard F, Fridell A, Coco C, Milne K, Chen NTM, Bolte S, Girdler S. KONTAKT(c) for Australian adolescents on the autism spectrum: protocol of a randomized control trial. Trials. 2019 Dec 9;20(1):687. doi: 10.1186/s13063-019-3721-9. Afsharnejad B, Falkmer M, Picen T, Black MH, Alach T, Fridell A, Coco C, Milne K, Perry J, Bolte S, Girdler S. "I Met Someone Like Me!": Autistic Adolescents and Their Parents' Experience of the KONTAKT(R) Social Skills Group Training. J Autism Dev Disord. 2022 Apr;52(4):1458-1477. doi: 10.1007/s10803-021-05045-1. Epub 2021 May 3. Afsharnejad B, Falkmer M, Black MH, Alach T, Lenhard F, Fridell A, Coco C, Milne K, Bolte S, Girdler S. KONTAKT(R) social skills group training for Australian adolescents with autism spectrum disorder: a randomized controlled trial. Eur Child Adolesc Psychiatry. 2022 Nov;31(11):1695-1713. doi: 10.1007/s00787-021-01814-6. Epub 2021 May 30.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Sonya J Girdler, PhD
Query!
Address
0
0
Occupational Therapy Professor - Curtin University
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Afsharnejad B, Falkmer M, Black MH, Alach T, Lenha...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT03294668