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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04024111
Registration number
NCT04024111
Ethics application status
Date submitted
12/07/2019
Date registered
18/07/2019
Date last updated
9/02/2024
Titles & IDs
Public title
Social Groups for Australian Children on the Autism Spectrum
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Scientific title
The Development and Evaluation of a Social Skills Group Training for Australian Children on the Autism Spectrum
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Secondary ID [1]
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HRE2017-0245-34
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder
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Condition category
Condition code
Mental Health
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Autistic spectrum disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - KONTAKT(c)
Other interventions - Art group
Experimental: KONTAKT(c) - A social skills group training
Active Comparator: Art group - A social Art group
Behaviour: KONTAKT(c)
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 75 minutes facilitated by two health professionals with experience of running groups for autistic children
Other interventions: Art group
Art program, a manualized Art group delivered in a social format, has been designed for children on the Autism Spectrum delivered by health professionals with experience of running social groups for Autistic children. The Art program's participants (4-8 participants) meet face to face weekly for 16 weeks for 75 minutes.
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Intervention code [1]
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Behaviour
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in the Goal Attainment Scale (GAS)
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Assessment method [1]
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The GOAL Attainment Scale will be used to measure if the participants have achieved the goals they have set for the program. Using the scale the children's 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. The achievement of these goals will be scored via the GAS scoring system of "-2" showing the participant's current level of performance, "-1" less than expected, "0" the expected progress, and "+1" and "+2" indicative of progress above the expected level
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Timepoint [1]
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Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
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Primary outcome [2]
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Change in Social Skills Assessment Questionnaire (SSAQ)
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Assessment method [2]
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Social Skills Assessment Questionnaire (SSAQ), is a 23-item parent proxy questionnaire measuring the change in a child's social skills abilities. the measure is rated on a 3-point Likert scale from "worse than peers" to "Better than peers". Higher total scores show better outcome. This measure has been used with the ASD population before.
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Timepoint [2]
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Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
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Secondary outcome [1]
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Change in the Emotion Regulation Checklist (ERC)
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Assessment method [1]
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2.3. The parents will fill this questionnaire (Parent form). This is a 24-item measure assessing : negativity/lability and emotion regulation. The questionnaire is designed to measure represents a different aspect of emotionality from a strengths perspective, i.e. emotional intelligence, resilience and coping and social and emotional competence. Responses are rated on a 4-point Likert scale, ranging from "rarely" to "almost".
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Timepoint [1]
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Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
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Secondary outcome [2]
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Change in the Negative Incidents and Effects of Psychological Treatment (NEQ)
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Assessment method [2]
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The parents (parent proxy) 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
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Timepoint [2]
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Post-test (week 20)
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Secondary outcome [3]
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Change in the Child Health Utility 9D (CHU9D)
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Assessment method [3]
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The children 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'.
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Timepoint [3]
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Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
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Secondary outcome [4]
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Change in Treatment Inventory of Costs in Patients (TIC-P)
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Assessment method [4]
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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
- Page 4 of 6 [DRAFT] both at and outside of school, medications and supplements, work, and education and productivity losses incurred by both parents and children.
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Timepoint [4]
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Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
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Secondary outcome [5]
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Treatment Satisfaction Scale
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Assessment method [5]
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The children 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.
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Timepoint [5]
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Post-test (week 20)
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Secondary outcome [6]
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Change in the Social responsiveness scale - Second Edition (SRS-2)
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Assessment method [6]
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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. The SRS-2 (2014) enables calculation of a universal score and five treatment subscales: social awareness, social cognition, social communication, social motivation, and restricted interests and repetitive behaviour. These subscales are designed to align closely with the DSM-5 criteria for ASD. The scale takes approximately 15 to 20 minutes to complete with items scored on a 4-point Likert-type scale, ranging from "not true (0)" to "almost always true (3)". The expected value for individuals with a primary diagnosis of ASD is approximately 100.
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Timepoint [6]
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Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
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Secondary outcome [7]
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International classification of functioning (ICF) - Autism coreset
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Assessment method [7]
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evaluates the impact of a disability and its context on an individual's functioning. For the purpose of this study only item related to the KONTAKT© objectives (social communication and interaction) will be selected from the Autism Core set after the manual has been translated to English.
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Timepoint [7]
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Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
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Secondary outcome [8]
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Junior Temperament and characteristic Inventory (JTCI)
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Assessment method [8]
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2.4. This parent-report and child self-report is derived from the International classification of functioning's autism coreset that identifies the personality traits of young children aged 6-16 under 5. Responses are dichotomous (True or False).
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Timepoint [8]
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Baseline (week 0), Post-test (week 20) and follow up (week 36)
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Secondary outcome [9]
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Motivation to participate
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Assessment method [9]
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is a weekly measure specifically designed for this study to evaluate the motivation to participate in the groups (both intervention and control) and will be assessed through a 2-item child and parent self-report and a parents proxy-report text, asking "On a scale of 1-5 (as demonstrated by emoji) how much did you like attending this week's group?" and "On a scale of 1-5 (as demonstrated by emoji) how interested are you in attending the next session?" To check for reliability, the results from this measure will be attached to the participants' attendance in the groups.
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Timepoint [9]
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Weekly through the intervention until post test time from week 1 to 20
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Secondary outcome [10]
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Change in the LERID friendship questionnaire
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Assessment method [10]
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the LERID friendship questionnaire is a 46-item self-report measure of children's perceptions of the quality of their relationship with their best friend around 11 different aspects of friendship experience: commitment, security, satisfaction, intimacy, protection from victimization, help, affection received from the friend, trust of the friend, trust received from the friend, comfort, Validation and Authenticity of the friendship. The measure is rated on a 5-point Likert scale from "Not true" (1) to "Really true" (5).
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Timepoint [10]
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Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
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Secondary outcome [11]
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Change in the Social Interaction anxiety scale (SIAS)
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Assessment method [11]
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Social Interaction Anxiety Scale (SIAS) is self-report used mainly with adults. The measure has been used with adolescents participating in the KONTAKT program. This study will only use the items which became significant in that study. The measure is scored on a 5-point Likert scale from "Not at all (0)" to "Extremely (4)". The higher scores on the scale indicate higher social interaction anxiety experienced.
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Timepoint [11]
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Weekly through the intervention until post test time from week 1 to 20
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Eligibility
Key inclusion criteria
- Individuals aged 8 to 12
- 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)
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Minimum age
8
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Maximum age
12
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2023
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Sample size
Target
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Accrual to date
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Final
84
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Curtin University - Bentley
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Recruitment postcode(s) [1]
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6102 - Bentley
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Funding & Sponsors
Primary sponsor type
Other
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Name
Curtin University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Autism Association of Western Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Stan Perron charitable trust
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Karolinska Institutet
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study evaluates the KONTAKT social skills group training in Australian children on the
autism spectrum compared to an active control group which is a group Art class
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04024111
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04024111
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