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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Australia1 site
  • Curtin University

    Bentley, Western Australia, 6102

Other trials in Australia

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

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 groups in NCT04024111
Study groupRoleWhat they receive
KONTAKT(c)ExperimentalA social skills group training
Receives: Behavioral: KONTAKT(c)
Art groupActive comparatorA social Art group
Receives: Other: Art group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  2. 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)
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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

  10. 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)

  11. 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.

  1. First posted18 Jul 2019
  2. Study start1 Dec 2019
  3. Primary completion1 Oct 2023
  4. Study completion1 Oct 2023

Resources

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)
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 41692033
  • Hayden-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 40316953
  • Afsharnejad 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

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.

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