Clinical trial NCT04024111: Social Groups for Australian Children on the Autism Spectrum
Official title: The Development and Evaluation of a Social Skills Group Training for Australian Children on the Autism Spectrum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Social groups
Active contol group
Children
Australian
Lead sponsor: Curtin University
Sponsor class: OTHER
Collaborators: name: Autism Association of Western Australia
name: Stan Perron charitable trust
name: Karolinska Institutet
First posted: 2019-07-18
Enrollment: 84
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants will be randomly allocated into an intervention group (KONTAKT Australia) and an active control group (Social Art group).
Primary purpose: TREATMENT

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

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 children on the autism spectrum compared to an active control group which is a group art class

Eligibility criteria: 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)

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

Primary outcomes:
measure: Change in the Goal Attainment Scale (GAS)
timeFrame: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
measure: Change in Social Skills Assessment Questionnaire (SSAQ)
timeFrame: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
Secondary outcomes:
measure: Change in the Emotion Regulation Checklist (ERC)
timeFrame: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
measure: Change in the Negative Incidents and Effects of Psychological Treatment (NEQ)
timeFrame: Post-test (week 20)
measure: Change in the Child Health Utility 9D (CHU9D)
timeFrame: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
measure: Change in Treatment Inventory of Costs in Patients (TIC-P)
timeFrame: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
measure: Treatment Satisfaction Scale
timeFrame: Post-test (week 20)
measure: Change in the Social responsiveness scale - Second Edition (SRS-2)
timeFrame: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
measure: International classification of functioning (ICF) - Autism coreset
timeFrame: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
measure: Junior Temperament and characteristic Inventory (JTCI)
timeFrame: Baseline (week 0), Post-test (week 20) and follow up (week 36)
measure: Motivation to participate
timeFrame: Weekly through the intervention until post test time from week 1 to 20
measure: Change in the LERID friendship questionnaire
timeFrame: Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks)
measure: Change in the Social Interaction anxiety scale (SIAS)
timeFrame: Weekly through the intervention until post test time from week 1 to 20
Other outcomes:
Locations:
city: Bentley
country: Australia
facility: Curtin University
state: Western Australia
Study officials:
References: