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

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ClinicalTrials.gov Identifier: NCT03294668
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
Autism Association of Western Australia
Karolinska Institutet
Information provided by (Responsible Party):
Sonya Girdler, Curtin University

Brief 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

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: KONTAKT Australia Other: Super Chef Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The participants will be randomly allocated into an intervention group (KONTAKT Australia) and an active control group (Social cooking group).
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The Assessor is blind to the participant's allocation to the intervention and active control group.
Primary Purpose: Treatment
Official Title: Developing and Evaluating a Social Skills Group Training for Adolescents on the Autism Spectrum
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : October 6, 2019
Estimated Study Completion Date : December 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: KONTAKT Australia
A social skills group training
Behavioral: KONTAKT 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.
Other Name: KONTAKT

Active Comparator: Super Chef
A social cooking group
Other: Super 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.
Other Name: Social cooking group




Primary Outcome Measures :
  1. Change in the Goal Attainment Scale (GAS) [ Time Frame: Baseline (week 0), Post-test (week 20) and follow up (week 36) ]
    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.


Secondary Outcome Measures :
  1. Change in the Emotion Regulation and Social Skills Questionnaire (ERSSQ) [ Time Frame: Baseline (week 0), Post-test (week 20) and follow up (week 36) ]
    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.

  2. 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.

  3. 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).

  4. 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.

  5. Change in the Perth Loneliness Scale (PALs) [ Time Frame: Baseline (week 0), Post-test (week 20) and follow up (week 36) ]
    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).

  6. 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

  7. Change in the Child Health Utility 9D (CHU9D) [ Time Frame: Baseline (week 0), Post-test (week 20) and follow up (week 36) ]
    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'.

  8. 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).

  9. Change in Social Interaction Anxiety Scale (SIAS) [ Time Frame: Baseline (week 0), Post-test (week 20) and follow up (week 36) ]
    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

  10. Change in Treatment Inventory of Costs in Patients (TIC-P) [ Time Frame: Baseline (week 0), Post-test (week 20) and follow up (week 36) ]
    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.

  11. 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

  12. 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.

  13. Change in the Social responsiveness scale - Second Edition (SRS-2) [ Time Frame: Baseline (week 0), Post-test (week 20) and follow up (week 36) ]
    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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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294668


Contacts
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Contact: Sonya J Girdler, PhD +61 8 9266 3630 sonya.girdler@gmail.com
Contact: Bahareh Afsharnejad, MS bahareh.afsharnejad@postgrad.curtin.edu.au

Locations
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Australia, Western Australia
Curtin University Recruiting
Bentley, Western Australia, Australia, 6102
Contact: Sonya J Girdler    +61 8 9266 3630    sonya.girdler@gmail.com   
Contact: Bahareh Afsharnejad       bahareh.afsharnejad@postgrad.curtin.edu.au   
Sponsors and Collaborators
Curtin University
Autism Association of Western Australia
Karolinska Institutet
Investigators
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Principal Investigator: Sonya J Girdler, PhD Professor at Curtin University

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Responsible Party: Sonya Girdler, Associate Professor, Curtin University
ClinicalTrials.gov Identifier: NCT03294668     History of Changes
Other Study ID Numbers: HRE2017-0245
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sonya Girdler, Curtin University:
social skills group training
Adolescents
Active control group
Australian

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders