NCT03294668

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2020

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

2.7 years

First QC Date

September 22, 2017

Last Update Submit

July 25, 2022

Conditions

Autism Spectrum Disorder

Keywords

social skills group trainingAdolescentsActive control groupAustralian

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)

Secondary Outcomes (13)

  • Change in the Emotion Regulation and Social Skills Questionnaire (ERSSQ)

    Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)

  • Mind Reading Battery

    Baseline (week 0), Post-test (week 20) and follow up (week 36)

  • Change in the Circumplex Scale of Interpersonal Efficacy (CSIE)

    Baseline (week 0), Post-test (week 20) and follow up (week 36)

  • Change in the Paediatric Quality of life Inventory- 4th edition (PedQL-4.0)

    Baseline (week 0), Post-test (week 20) and follow up (week 36)

  • Change in the Perth Loneliness Scale (PALs)

    Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)

  • +8 more secondary outcomes

Study Arms (2)

KONTAKT Australia

EXPERIMENTAL

A social skills group training

Behavioral: KONTAKT Australia

Super Chef

ACTIVE COMPARATOR

A social cooking group

Other: Super Chef

Interventions

KONTAKT AustraliaBEHAVIORAL

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.

Also known as: KONTAKT
KONTAKT Australia
Super ChefOTHER

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.

Also known as: Social cooking group
Super Chef

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Curtin University

Bentley, Western Australia, 6102, Australia

Location

Related Publications (4)

  • 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.

    PMID: 32270385BACKGROUND

  • 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.

    PMID: 31815642BACKGROUND

  • 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.

    PMID: 33942186BACKGROUND

  • 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.

    PMID: 34052908RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Sonya J Girdler, PhD

    Occupational Therapy Professor - Curtin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The Assessor is blind to the participant's allocation to the intervention and active control group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The participants will be randomly allocated into an intervention group (KONTAKT Australia) and an active control group (Social cooking group).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 22, 2017

First Posted

September 27, 2017

Study Start

February 1, 2017

Primary Completion

October 6, 2019

Study Completion

October 25, 2020

Last Updated

July 28, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)