KONTAKT Australia a Social Skills Group Training for Adolescents on the Autism Spectrum
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
KONTAKT Australia
Super Chef
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring social skills group training, Adolescents, Active control group, Australian
Eligibility 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
Sites / Locations
- Curtin University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
KONTAKT Australia
Super Chef
Arm Description
A social skills group training
A social cooking group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
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.
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).
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
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'.
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).
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
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.
Change in social functioning
This will be assessed by a blinded assessor
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.
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.
Full Information
NCT ID
NCT03294668
First Posted
September 22, 2017
Last Updated
July 25, 2022
Sponsor
Curtin University
Collaborators
Autism Association of Western Australia, Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT03294668
Brief Title
KONTAKT Australia a Social Skills Group Training for Adolescents on the Autism Spectrum
Official Title
Developing and Evaluating a Social Skills Group Training for Adolescents on the Autism Spectrum
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
October 6, 2019 (Actual)
Study Completion Date
October 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Curtin University
Collaborators
Autism Association of Western Australia, Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
social skills group training, Adolescents, Active control group, Australian
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The participants will be randomly allocated into an intervention group (KONTAKT Australia) and an active control group (Social cooking group).
Masking
InvestigatorOutcomes Assessor
Masking Description
The Assessor is blind to the participant's allocation to the intervention and active control group.
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KONTAKT Australia
Arm Type
Experimental
Arm Description
A social skills group training
Arm Title
Super Chef
Arm Type
Active Comparator
Arm Description
A social cooking group
Intervention Type
Behavioral
Intervention Name(s)
KONTAKT Australia
Other Intervention Name(s)
KONTAKT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Super Chef
Other Intervention Name(s)
Social cooking group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Goal Attainment Scale (GAS)
Description
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 Outcome Measure Information:
Title
Change in the Emotion Regulation and Social Skills Questionnaire (ERSSQ)
Description
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)
Title
Mind Reading Battery
Description
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)
Title
Change in the Circumplex Scale of Interpersonal Efficacy (CSIE)
Description
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)
Title
Change in the Paediatric Quality of life Inventory- 4th edition (PedQL-4.0)
Description
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)
Title
Change in the Perth Loneliness Scale (PALs)
Description
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)
Title
Change in the Negative Incidents and Effects of Psychological Treatment (NEQ)
Description
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)
Title
Change in the Child Health Utility 9D (CHU9D)
Description
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)
Title
Change in Emotions via Experience Sampling (ESM)
Description
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
Title
Change in Social Interaction Anxiety Scale (SIAS)
Description
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)
Title
Change in Treatment Inventory of Costs in Patients (TIC-P)
Description
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)
Title
Change in social functioning
Description
This will be assessed by a blinded assessor
Time Frame
Time 1 (week 3), Time 2 (week 13 ), Time 3 (week 19)
Title
Treatment Satisfaction Scale
Description
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)
Title
Change in the Social responsiveness scale - Second Edition (SRS-2)
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonya J Girdler, PhD
Organizational Affiliation
Occupational Therapy Professor - Curtin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Curtin University
City
Bentley
State/Province
Western Australia
ZIP/Postal Code
6102
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32270385
Citation
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.
Results Reference
background
PubMed Identifier
31815642
Citation
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.
Results Reference
background
PubMed Identifier
33942186
Citation
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.
Results Reference
background
PubMed Identifier
34052908
Citation
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.
Results Reference
result
Learn more about this trial
KONTAKT Australia a Social Skills Group Training for Adolescents on the Autism Spectrum
We'll reach out to this number within 24 hrs