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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
The Development and Evaluation of a Social Skills Group Training for Australian Children on the Autism Spectrum
Secondary ID [1] 0 0
HRE2017-0245-34
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
BEHAVIORAL - KONTAKT(c)
Other interventions - Art group

Experimental: KONTAKT(c) - A social skills group training

Active comparator: Art group - A social Art group


BEHAVIORAL: 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.
Intervention code [1] 0 0
BEHAVIORAL
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)
Timepoint [1] 0 0
Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Primary outcome [2] 0 0
Change in Social Skills Assessment Questionnaire (SSAQ)
Timepoint [2] 0 0
Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Secondary outcome [1] 0 0
Change in the Emotion Regulation Checklist (ERC)
Timepoint [1] 0 0
Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Secondary outcome [2] 0 0
Change in the Negative Incidents and Effects of Psychological Treatment (NEQ)
Timepoint [2] 0 0
Post-test (week 20)
Secondary outcome [3] 0 0
Change in the Child Health Utility 9D (CHU9D)
Timepoint [3] 0 0
Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Secondary outcome [4] 0 0
Change in Treatment Inventory of Costs in Patients (TIC-P)
Timepoint [4] 0 0
Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Secondary outcome [5] 0 0
Treatment Satisfaction Scale
Timepoint [5] 0 0
Post-test (week 20)
Secondary outcome [6] 0 0
Change in the Social responsiveness scale - Second Edition (SRS-2)
Timepoint [6] 0 0
Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Secondary outcome [7] 0 0
International classification of functioning (ICF) - Autism coreset
Timepoint [7] 0 0
Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Secondary outcome [8] 0 0
Junior Temperament and characteristic Inventory (JTCI)
Timepoint [8] 0 0
Baseline (week 0), Post-test (week 20) and follow up (week 36)
Secondary outcome [9] 0 0
Motivation to participate
Timepoint [9] 0 0
Weekly through the intervention until post test time from week 1 to 20
Secondary outcome [10] 0 0
Change in the LERID friendship questionnaire
Timepoint [10] 0 0
Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Secondary outcome [11] 0 0
Change in the Social Interaction anxiety scale (SIAS)
Timepoint [11] 0 0
Weekly through the intervention until post test time from week 1 to 20

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)
Minimum age
8 Years
Maximum age
12 Years
Sex
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 receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2023
Sample size
Target
Accrual to date
Final
84
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
Stan Perron charitable trust
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Karolinska Institutet
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT04024111
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04024111