- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03294668
KONTAKT Australia a Social Skills Group Training for Adolescents on the Autism Spectrum
July 25, 2022 updated by: Sonya Girdler, Curtin University
Developing and Evaluating a Social Skills Group Training for Adolescents on the Autism Spectrum
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
KONTAKT is a manualized Social Skills Group Training 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.
Moreover, in the previous studies, the social skills groups were compared to treatment as usual groups.
Therefore, 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
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Western Australia
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Bentley, Western Australia, Australia, 6102
- Curtin University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: KONTAKT Australia
A social skills group training
|
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 Names:
|
|
ACTIVE_COMPARATOR: Super Chef
A social cooking group
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Goal Attainment Scale (GAS)
Time Frame: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
|
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.
|
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Emotion Regulation and Social Skills Questionnaire (ERSSQ)
Time Frame: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
|
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.
|
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
|
|
Mind Reading Battery
Time Frame: Baseline (week 0), Post-test (week 20) and follow up (week 36)
|
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.
|
Baseline (week 0), Post-test (week 20) and follow up (week 36)
|
|
Change in the Circumplex Scale of Interpersonal Efficacy (CSIE)
Time Frame: Baseline (week 0), Post-test (week 20) and follow up (week 36)
|
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).
|
Baseline (week 0), Post-test (week 20) and follow up (week 36)
|
|
Change in the Paediatric Quality of life Inventory- 4th edition (PedQL-4.0)
Time Frame: Baseline (week 0), Post-test (week 20) and follow up (week 36)
|
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.
|
Baseline (week 0), Post-test (week 20) and follow up (week 36)
|
|
Change in the Perth Loneliness Scale (PALs)
Time Frame: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
|
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).
|
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
|
|
Change in the Negative Incidents and Effects of Psychological Treatment (NEQ)
Time Frame: Post-test (week 20) and follow up (week 36)
|
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
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Post-test (week 20) and follow up (week 36)
|
|
Change in the Child Health Utility 9D (CHU9D)
Time Frame: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
|
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'.
|
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
|
|
Change in Emotions via Experience Sampling (ESM)
Time Frame: Through the intervention until follow up time from week 1 to 36
|
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).
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Through the intervention until follow up time from week 1 to 36
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Change in Social Interaction Anxiety Scale (SIAS)
Time Frame: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
|
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
|
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
|
|
Change in Treatment Inventory of Costs in Patients (TIC-P)
Time Frame: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
|
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.
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Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
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Change in social functioning
Time Frame: Time 1 (week 3), Time 2 (week 13 ), Time 3 (week 19)
|
This will be assessed by a blinded assessor
|
Time 1 (week 3), Time 2 (week 13 ), Time 3 (week 19)
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Treatment Satisfaction Scale
Time Frame: Post-test (week 20)
|
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.
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Post-test (week 20)
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Change in the Social responsiveness scale - Second Edition (SRS-2)
Time Frame: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
|
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.
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Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sonya J Girdler, PhD, Occupational Therapy Professor - Curtin University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2017
Primary Completion (ACTUAL)
October 6, 2019
Study Completion (ACTUAL)
October 25, 2020
Study Registration Dates
First Submitted
September 22, 2017
First Submitted That Met QC Criteria
September 25, 2017
First Posted (ACTUAL)
September 27, 2017
Study Record Updates
Last Update Posted (ACTUAL)
July 28, 2022
Last Update Submitted That Met QC Criteria
July 25, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRE2017-0245
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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