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CompletedNCT03294668Updated Jul 28, 2022

KONTAKT Australia a Social Skills Group Training for Adolescents on the Autism Spectrum

An interventional study of KONTAKT Australia and Super Chef in Autism Spectrum Disorder, sponsored by Curtin University. Completed at 1 site in Australia. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-07-28.

Sponsored by Curtin University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Autism Spectrum Disorder

Keywords

  • social skills group training
  • Adolescents
  • Active control group
  • Australian
03

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    KONTAKT Australia

    A social skills group training

    Behavioral: KONTAKT Australia

  • Active comparator
    Super Chef

    A social cooking group

    Other: Super Chef

Interventions

  • BehavioralKONTAKT 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.

    Also known as: KONTAKT

  • OtherSuper 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.

    Also known as: Social cooking group

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)

Secondary outcomes

  1. 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.

    Time frame: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)

  2. 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.

    Time frame: Baseline (week 0), Post-test (week 20) and follow up (week 36)

  3. 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).

    Time frame: Baseline (week 0), Post-test (week 20) and follow up (week 36)

  4. 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.

    Time frame: Baseline (week 0), Post-test (week 20) and follow up (week 36)

  5. 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).

    Time frame: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)

  6. 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

    Time frame: Post-test (week 20) and follow up (week 36)

  7. 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'.

    Time frame: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)

  8. 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).

    Time frame: Through the intervention until follow up time from week 1 to 36

  9. 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

    Time frame: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)

  10. 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.

    Time frame: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)

  11. Change in social functioning

    This will be assessed by a blinded assessor

    Time frame: Time 1 (week 3), Time 2 (week 13 ), Time 3 (week 19)

  12. 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.

    Time frame: Post-test (week 20)

  13. 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.

    Time frame: Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)

06

Study locations

1 site
  • Curtin University
    Bentley, Western Australia 6102, Australia
07

References and documents

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 32270385 ↗
  • 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. PubMed 31815642 ↗
  • 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. PubMed 33942186 ↗
  • 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. PubMed 34052908 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03294668
Lead sponsor
Curtin University
Collaborators
Autism Association of Western Australia, Karolinska Institutet
Responsible party
Sonya Girdler (Associate Professor, Curtin University) — Principal investigator
First posted
Sep 27, 2017
Start date
Feb 1, 2017
Primary completion
Oct 6, 2019
Completion
Oct 25, 2020
Last update
Jul 28, 2022

Study contacts

Sonya J Girdler, PhD
principal investigator · Occupational Therapy Professor - Curtin University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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