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
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: KONTAKT Australia Other: Super Chef||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|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.|
|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|
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
- 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.
- 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.
- 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.
- 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).
- 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.
- 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).
- 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
- 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'.
- 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).
- 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
- 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.
- 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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294668
|Contact: Sonya J Girdler, PhD||+61 8 9266 email@example.com|
|Contact: Bahareh Afsharnejad, MSfirstname.lastname@example.org|
|Australia, Western Australia|
|Bentley, Western Australia, Australia, 6102|
|Contact: Sonya J Girdler +61 8 9266 3630 email@example.com|
|Contact: Bahareh Afsharnejad firstname.lastname@example.org|
|Principal Investigator:||Sonya J Girdler, PhD||Professor at Curtin University|