Autism Spectrum DisorderNCT03294668
KONTAKT Australia a Social Skills Group Training for Adolescents on the Autism Spectrum
A study testing KONTAKT Australia and Super Chef in people with Autism Spectrum Disorder, run by Curtin University at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- KONTAKT Australia and Super Chef
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Feb 2017to 25 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Autism Spectrum Disorder
- Being tested
- KONTAKT Australia, Super Chef
- Keywords
- social skills group training, Adolescents, Active control group, Australian
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KONTAKT AustraliaBehavioural
Also called KONTAKT
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.
Super ChefOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| KONTAKT Australia | Experimental | A social skills group training Receives: Behavioral: KONTAKT Australia |
| Super Chef | Active comparator | A social cooking group Receives: Other: Super Chef |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Goal Attainment Scale (GAS)
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.
Measured: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Secondary outcomes (13)
Change in the Emotion Regulation and Social Skills Questionnaire (ERSSQ)
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.
Measured: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Mind Reading Battery
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.
Measured: Baseline (week 0), Post-test (week 20) and follow up (week 36)
Change in the Circumplex Scale of Interpersonal Efficacy (CSIE)
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).
Measured: 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)
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.
Measured: Baseline (week 0), Post-test (week 20) and follow up (week 36)
Change in the Perth Loneliness Scale (PALs)
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).
Measured: 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)
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
Measured: Post-test (week 20) and follow up (week 36)
Change in the Child Health Utility 9D (CHU9D)
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'.
Measured: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Change in Emotions via Experience Sampling (ESM)
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).
Measured: Through the intervention until follow up time from week 1 to 36
Change in Social Interaction Anxiety Scale (SIAS)
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
Measured: 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)
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.
Measured: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Change in social functioning
This will be assessed by a blinded assessor
Measured: Time 1 (week 3), Time 2 (week 13 ), Time 3 (week 19)
Treatment Satisfaction Scale
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.
Measured: Post-test (week 20)
Change in the Social responsiveness scale - Second Edition (SRS-2)
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.
Measured: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start1 Feb 2017
- Primary completion6 Oct 2019
- Study completion25 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be randomly allocated into an intervention group (KONTAKT Australia) and an active control group (Social cooking group).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curtin University
- Sponsor type
- University, hospital or other
- Collaborators
- Autism Association of Western Australia, Karolinska Institutet
- Responsible party
- Principal investigator, Sonya Girdler, Curtin University
- Investigators
- Sonya J Girdler, PhD, Principal investigator, Occupational Therapy Professor - Curtin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294668
- Sponsor's protocol ID
- HRE2017-0245
- Status last verified
- Jul 2022
- First submitted
- 22 Sep 2017
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32270385Afsharnejad 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.
PubMed 31815642Afsharnejad 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.
PubMed 33942186Afsharnejad 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.
PubMed 34052908
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Evaluating a Social Skills Group Training for Adolescents on the Autism Spectrum
- ClinicalTrials.gov ID
- NCT03294668
- Acronym / sponsor ID
- HRE2017-0245
- Conditions
- Autism Spectrum Disorder
- Keywords
- social skills group training, Adolescents, Active control group, Australian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Curtin UniversityUniversity, hospital or other
- Collaborators
- Autism Association of Western Australia, Karolinska Institutet
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 6 Oct 2019 (actual)
- Study completion
- 25 Oct 2020 (actual)
- First posted
- 27 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The participants will be randomly allocated into an intervention group (KONTAKT Australia) and an active control group (Social cooking group).
| Arm | Type | Receives |
|---|---|---|
| KONTAKT Australia | Experimental | Behavioral: KONTAKT AustraliaA social skills group training |
| Super Chef | Active comparator | Other: Super ChefA social cooking group |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KONTAKT AustraliaAlso: KONTAKTKONTAKT 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. | Behavioural | KONTAKT Australia |
| Super ChefAlso: Social cooking groupThe 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 | Super Chef |
Primary outcome
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.
13 secondary outcomes
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)
Mind Reading Battery
Time frame: 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)
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)
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)
Change in the Negative Incidents and Effects of Psychological Treatment (NEQ)
Time frame: 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)
Change in Emotions via Experience Sampling (ESM)
Time frame: Through the intervention until follow up time from week 1 to 36
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)
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)
Change in social functioning
Time frame: Time 1 (week 3), Time 2 (week 13 ), Time 3 (week 19)
Treatment Satisfaction Scale
Time frame: Post-test (week 20)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Background: PubMed 32270385Afsharnejad 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.
- Background: PubMed 31815642Afsharnejad 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.
- Background: PubMed 33942186Afsharnejad 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.
- Results publication: PubMed 34052908Afsharnejad 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonya J Girdler, PhD principal investigator
Occupational Therapy Professor - Curtin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KONTAKT Australia and Super Chef in people with Autism Spectrum Disorder, run by Curtin University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03294668, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.