NCT04024111

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 Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

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

First Submitted

Initial submission to the registry

July 12, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

3.8 years

First QC Date

July 12, 2019

Last Update Submit

February 7, 2024

Conditions

Keywords

Social groupsActive contol groupChildrenAustralian

Outcome Measures

Primary Outcomes (2)

  • Change in the Goal Attainment Scale (GAS)

    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

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

  • Change in Social Skills Assessment Questionnaire (SSAQ)

    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.

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

Secondary Outcomes (11)

  • Change in the Emotion Regulation Checklist (ERC)

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

  • Change in the Negative Incidents and Effects of Psychological Treatment (NEQ)

    Post-test (week 20)

  • Change in the Child Health Utility 9D (CHU9D)

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

  • Change in Treatment Inventory of Costs in Patients (TIC-P)

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

  • Treatment Satisfaction Scale

    Post-test (week 20)

  • +6 more secondary outcomes

Study Arms (2)

KONTAKT(c)

EXPERIMENTAL

A social skills group training

Behavioral: KONTAKT(c)

Art group

ACTIVE COMPARATOR

A social Art group

Other: Art group

Interventions

KONTAKT(c)BEHAVIORAL

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

KONTAKT(c)

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.

Art group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

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 (2)

  • Hayden-Evans M, Afsharnejad B, Lee EAL, Milbourn B, Picen T, Johnson M, Bolte S, Girdler S. "I made friends a lot more easily": children and families' experiences of social group programs for children on the autism spectrum. BMC Pediatr. 2025 May 3;25(1):353. doi: 10.1186/s12887-025-05686-6.

  • Afsharnejad B, Lee EAL, Hayden-Evans M, Black MH, Alach T, Fridell A, Coco C, Johnson M, Bolte S, Girdler S. Adaptation and Feasibility of KONTAKT Social Skills Toolbox Group Program for Australian Autistic Children. Scand J Child Adolesc Psychiatr Psychol. 2024 Dec 5;12(1):20240011. doi: 10.2478/sjcapp-2024-0011. eCollection 2024 Jan.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The Assessor is blind to the participant's allocation to the intervention and active control group and the participants and carers are told they are participating in different social groups
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 Art group).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 12, 2019

First Posted

July 18, 2019

Study Start

December 1, 2019

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Have no ethics to do this

Locations