Autism Spectrum DisorderNCT04024111
Social Groups for Australian Children on the Autism Spectrum
A study testing KONTAKT(c) and Art group 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 children on the autism spectrum compared to an active control group which is a group Art class Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- KONTAKT(c) and Art group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Dec 2019to 1 Oct 2023
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Individuals aged 8 to 12
- 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: The Development and Evaluation of a Social Skills Group Training for Australian Children on the Autism Spectrum
This study evaluates the KONTAKT social skills group training in Australian children on the autism spectrum compared to an active control group which is a group Art 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 children on the autism spectrum compared to an active control group which is a group art class
- Conditions
- Autism Spectrum Disorder
- Being tested
- KONTAKT(c), Art group
- Keywords
- Social groups, Active contol group, Children, 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(c)Behavioural
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 75 minutes facilitated by two health professionals with experience of running groups for autistic children
Art groupOther
Art program, a manualized Art group delivered in a social format, has been designed for children on the Autism Spectrum delivered by health professionals with experience of running social groups for Autistic children. The Art program's participants (4-8 participants) meet face to face weekly for 16 weeks for 75 minutes.
| Study group | Role | What they receive |
|---|---|---|
| KONTAKT(c) | Experimental | A social skills group training Receives: Behavioral: KONTAKT(c) |
| Art group | Active comparator | A social Art group Receives: Other: Art group |
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 to measure if the participants have achieved the goals they have set for the program. Using the scale the children's 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. The achievement of these goals will be scored via the GAS scoring system of "-2" showing the participant's current level of performance, "-1" less than expected, "0" the expected progress, and "+1" and "+2" indicative of progress above the expected level
Measured: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Change in Social Skills Assessment Questionnaire (SSAQ)
Social Skills Assessment Questionnaire (SSAQ), is a 23-item parent proxy questionnaire measuring the change in a child's social skills abilities. the measure is rated on a 3-point Likert scale from "worse than peers" to "Better than peers". Higher total scores show better outcome. This measure has been used with the ASD population before.
Measured: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Secondary outcomes (11)
Change in the Emotion Regulation Checklist (ERC)
2.3. The parents will fill this questionnaire (Parent form). This is a 24-item measure assessing : negativity/lability and emotion regulation. The questionnaire is designed to measure represents a different aspect of emotionality from a strengths perspective, i.e. emotional intelligence, resilience and coping and social and emotional competence. Responses are rated on a 4-point Likert scale, ranging from "rarely" to "almost".
Measured: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Change in the Negative Incidents and Effects of Psychological Treatment (NEQ)
The parents (parent proxy) 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)
Change in the Child Health Utility 9D (CHU9D)
The children 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) and follow up (week 36) and long follow up (74 weeks)
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
- Page 4 of 6 [DRAFT] both at and outside of school, medications and supplements, work, and education and productivity losses incurred by both parents and children.
Measured: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Treatment Satisfaction Scale
The children 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. The SRS-2 (2014) enables calculation of a universal score and five treatment subscales: social awareness, social cognition, social communication, social motivation, and restricted interests and repetitive behaviour. These subscales are designed to align closely with the DSM-5 criteria for ASD. The scale takes approximately 15 to 20 minutes to complete with items scored on a 4-point Likert-type scale, ranging from "not true (0)" to "almost always true (3)". The expected value for individuals with a primary diagnosis of ASD is approximately 100.
Measured: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
International classification of functioning (ICF) - Autism coreset
evaluates the impact of a disability and its context on an individual's functioning. For the purpose of this study only item related to the KONTAKT© objectives (social communication and interaction) will be selected from the Autism Core set after the manual has been translated to English.
Measured: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Junior Temperament and characteristic Inventory (JTCI)
2.4. This parent-report and child self-report is derived from the International classification of functioning's autism coreset that identifies the personality traits of young children aged 6-16 under 5. Responses are dichotomous (True or False).
Measured: Baseline (week 0), Post-test (week 20) and follow up (week 36)
Motivation to participate
is a weekly measure specifically designed for this study to evaluate the motivation to participate in the groups (both intervention and control) and will be assessed through a 2-item child and parent self-report and a parents proxy-report text, asking "On a scale of 1-5 (as demonstrated by emoji) how much did you like attending this week's group?" and "On a scale of 1-5 (as demonstrated by emoji) how interested are you in attending the next session?" To check for reliability, the results from this measure will be attached to the participants' attendance in the groups.
Measured: Weekly through the intervention until post test time from week 1 to 20
Change in the LERID friendship questionnaire
the LERID friendship questionnaire is a 46-item self-report measure of children's perceptions of the quality of their relationship with their best friend around 11 different aspects of friendship experience: commitment, security, satisfaction, intimacy, protection from victimization, help, affection received from the friend, trust of the friend, trust received from the friend, comfort, Validation and Authenticity of the friendship. The measure is rated on a 5-point Likert scale from "Not true" (1) to "Really true" (5).
Measured: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Change in the Social Interaction anxiety scale (SIAS)
Social Interaction Anxiety Scale (SIAS) is self-report used mainly with adults. The measure has been used with adolescents participating in the KONTAKT program. This study will only use the items which became significant in that study. The measure is scored on a 5-point Likert scale from "Not at all (0)" to "Extremely (4)". The higher scores on the scale indicate higher social interaction anxiety experienced.
Measured: Weekly through the intervention until post test time from week 1 to 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Dec 2019
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Art group).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curtin University
- Sponsor type
- University, hospital or other
- Collaborators
- Autism Association of Western Australia, Stan Perron charitable trust, Karolinska Institutet
- Responsible party
- Principal investigator, Sonya Girdler, Curtin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024111
- Sponsor's protocol ID
- HRE2017-0245-34
- Status last verified
- Feb 2024
- First submitted
- 12 Jul 2019
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Have no ethics to do this
Publications
Afsharnejad B, Lee EAL, Hayden-Evans M, Fridell A, Coco C, Alach T, Johnson M, Bolte S, Girdler S. A double-masked randomised actively controlled trial of KONTAKT social skills toolbox for Australian autistic children. Autism. 2026 Mar;30(3):748-766. doi: 10.1177/13623613251414902. Epub 2026 Feb 15.
PubMed 41692033Hayden-Evans M, Afsharnejad B, Lee EAL, Milbourn B, Picen T, Johnson M, Bolte S, Girdler S. "I made friends a lot more easily": children and families' experiences of social group programs for children on the autism spectrum. BMC Pediatr. 2025 May 3;25(1):353. doi: 10.1186/s12887-025-05686-6.
PubMed 40316953Afsharnejad B, Lee EAL, Hayden-Evans M, Black MH, Alach T, Fridell A, Coco C, Johnson M, Bolte S, Girdler S. Adaptation and Feasibility of KONTAKT Social Skills Toolbox Group Program for Australian Autistic Children. Scand J Child Adolesc Psychiatr Psychol. 2024 Dec 5;12(1):20240011. doi: 10.2478/sjcapp-2024-0011. eCollection 2024 Jan.
PubMed 39649127
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Evaluation of a Social Skills Group Training for Australian Children on the Autism Spectrum
- ClinicalTrials.gov ID
- NCT04024111
- Acronym / sponsor ID
- HRE2017-0245-34
- Conditions
- Autism Spectrum Disorder
- Keywords
- Social groups, Active contol group, Children, Australian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Curtin UniversityUniversity, hospital or other
- Collaborators
- Autism Association of Western Australia, Stan Perron charitable trust, Karolinska Institutet
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 18 Jul 2019 (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 children on the autism spectrum compared to an active control group which is a group Art 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 children on the autism spectrum compared to an active control group which is a group art class
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, 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 Art group).
| Arm | Type | Receives |
|---|---|---|
| KONTAKT(c) | Experimental | Behavioral: KONTAKT(c)A social skills group training |
| Art group | Active comparator | Other: Art groupA social Art group |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Individuals aged 8 to 12
- 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 (3 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(c)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 75 minutes facilitated by two health professionals with experience of running groups for autistic children | Behavioural | KONTAKT(c) |
| Art groupArt program, a manualized Art group delivered in a social format, has been designed for children on the Autism Spectrum delivered by health professionals with experience of running social groups for Autistic children. The Art program's participants (4-8 participants) meet face to face weekly for 16 weeks for 75 minutes. | Other | Art group |
Primary outcome
Change in the Goal Attainment Scale (GAS)
Time frame: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
The GOAL Attainment Scale will be used to measure if the participants have achieved the goals they have set for the program. Using the scale the children's 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. The achievement of these goals will be scored via the GAS scoring system of "-2" showing the participant's current level of performance, "-1" less than expected, "0" the expected progress, and "+1" and "+2" indicative of progress above the expected level
Change in Social Skills Assessment Questionnaire (SSAQ)
Time frame: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Social Skills Assessment Questionnaire (SSAQ), is a 23-item parent proxy questionnaire measuring the change in a child's social skills abilities. the measure is rated on a 3-point Likert scale from "worse than peers" to "Better than peers". Higher total scores show better outcome. This measure has been used with the ASD population before.
11 secondary outcomes
Change in the Emotion Regulation Checklist (ERC)
Time frame: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Change in the Negative Incidents and Effects of Psychological Treatment (NEQ)
Time frame: Post-test (week 20)
Change in the Child Health Utility 9D (CHU9D)
Time frame: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Change in Treatment Inventory of Costs in Patients (TIC-P)
Time frame: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
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) and follow up (week 36) and long follow up (74 weeks)
International classification of functioning (ICF) - Autism coreset
Time frame: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Junior Temperament and characteristic Inventory (JTCI)
Time frame: Baseline (week 0), Post-test (week 20) and follow up (week 36)
Motivation to participate
Time frame: Weekly through the intervention until post test time from week 1 to 20
Change in the LERID friendship questionnaire
Time frame: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Change in the Social Interaction anxiety scale (SIAS)
Time frame: Weekly through the intervention until post test time from week 1 to 20
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 9 Feb 2024.
- Derived from this study: PubMed 41692033Afsharnejad B, Lee EAL, Hayden-Evans M, Fridell A, Coco C, Alach T, Johnson M, Bolte S, Girdler S. A double-masked randomised actively controlled trial of KONTAKT social skills toolbox for Australian autistic children. Autism. 2026 Mar;30(3):748-766. doi: 10.1177/13623613251414902. Epub 2026 Feb 15.
- Derived from this study: PubMed 40316953Hayden-Evans M, Afsharnejad B, Lee EAL, Milbourn B, Picen T, Johnson M, Bolte S, Girdler S. "I made friends a lot more easily": children and families' experiences of social group programs for children on the autism spectrum. BMC Pediatr. 2025 May 3;25(1):353. doi: 10.1186/s12887-025-05686-6.
- Derived from this study: PubMed 39649127Afsharnejad B, Lee EAL, Hayden-Evans M, Black MH, Alach T, Fridell A, Coco C, Johnson M, Bolte S, Girdler S. Adaptation and Feasibility of KONTAKT Social Skills Toolbox Group Program for Australian Autistic Children. Scand J Child Adolesc Psychiatr Psychol. 2024 Dec 5;12(1):20240011. doi: 10.2478/sjcapp-2024-0011. eCollection 2024 Jan.
- Individual participant dataSharing planned: No. Have no ethics to do this
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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.
The record lists no contact. Use the official record to reach the sponsor.
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(c) and Art group 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 3 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 9 Feb 2024. 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) and follow up (week 36) and long follow up (74 weeks)). The study lists 2 primary outcomes in all. 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 NCT04024111, which also lists 3 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 9 Feb 2024.