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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03294668




Registration number
NCT03294668
Ethics application status
Date submitted
22/09/2017
Date registered
27/09/2017
Date last updated
27/01/2020

Titles & IDs
Public title
KONTAKT Australia a Social Skills Group Training for Adolescents on the Autism Spectrum
Scientific title
Developing and Evaluating a Social Skills Group Training for Adolescents on the Autism Spectrum
Secondary ID [1] 0 0
HRE2017-0245
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - KONTAKT Australia
Other interventions - Super Chef

Experimental: KONTAKT Australia - A social skills group training

Active Comparator: Super Chef - A social cooking group


Behaviour: 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 interventions: 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.

Intervention code [1] 0 0
Behaviour
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline (week 0), Post-test (week 20) and follow up (week 36)
Secondary outcome [3] 0 0
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).
Timepoint [3] 0 0
Baseline (week 0), Post-test (week 20) and follow up (week 36)
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline (week 0), Post-test (week 20) and follow up (week 36)
Secondary outcome [5] 0 0
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).
Timepoint [5] 0 0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Post-test (week 20) and follow up (week 36)
Secondary outcome [7] 0 0
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'.
Timepoint [7] 0 0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Secondary outcome [8] 0 0
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).
Timepoint [8] 0 0
Through the intervention until follow up time from week 1 to 36
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)
Secondary outcome [11] 0 0
Change in social functioning - This will be assessed by a blinded assessor
Timepoint [11] 0 0
Time 1 (week 3), Time 2 (week 13 ), Time 3 (week 19)
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
Post-test (week 20)
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)

Eligibility
Key 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)
Minimum age
12 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Curtin University - Bentley
Recruitment postcode(s) [1] 0 0
6102 - Bentley

Funding & Sponsors
Primary sponsor type
Other
Name
Curtin University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Autism Association of Western Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Karolinska Institutet
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT03294668
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sonya J Girdler, PhD
Address 0 0
Professor at Curtin University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications