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临床试验/NCT04024111
NCT04024111已完成不适用

The Development and Evaluation of a Social Skills Group Training for Australian Children on the Autism Spectrum

Curtin University2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
2
主要终点
Change in Social Skills Assessment Questionnaire (SSAQ)

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Change in Social Skills Assessment Questionnaire (SSAQ)

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

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.

Change in the Goal Attainment Scale (GAS)

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

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

次要结局

  • 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))
  • Junior Temperament and characteristic Inventory (JTCI)(Baseline (week 0), Post-test (week 20) and follow up (week 36))
  • Motivation to participate(Weekly through the intervention until post test time from week 1 to 20)
  • International classification of functioning (ICF) - Autism coreset(Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks))
  • 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 the Social responsiveness scale - Second Edition (SRS-2)(Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks))
  • Change in the LERID friendship questionnaire(Baseline (week 0), Post-test (week 20) and follow up (week 36) and long follow up (74 weeks))
  • Change in the Social Interaction anxiety scale (SIAS)(Weekly through the intervention until post test time from week 1 to 20)
  • 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))
  • Treatment Satisfaction Scale(Post-test (week 20))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sonya Girdler

Professor

Curtin University

研究点 (2)

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