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临床试验/NCT03294668
NCT03294668已完成不适用

Developing and Evaluating a Social Skills Group Training for Adolescents on the Autism Spectrum

Curtin University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年2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
90
试验地点
2
主要终点
Change in the Goal Attainment Scale (GAS)

研究概览

简要总结

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

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 adolescents on the autism spectrum compared to an active control group which is a group cooking 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
Double (Investigator, Outcomes Assessor)

盲法说明

The Assessor is blind to the participant's allocation to the intervention and active control group.

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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)

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 the Goal Attainment Scale (GAS)

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

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.

次要结局

  • Mind Reading Battery(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))
  • Change in the Negative Incidents and Effects of Psychological Treatment (NEQ)(Post-test (week 20) and follow up (week 36))
  • Change in the Child Health Utility 9D (CHU9D)(Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74))
  • Change in Social Interaction Anxiety Scale (SIAS)(Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74))
  • 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))
  • Change in Treatment Inventory of Costs in Patients (TIC-P)(Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74))
  • Treatment Satisfaction Scale(Post-test (week 20))
  • 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 social functioning(Time 1 (week 3), Time 2 (week 13 ), Time 3 (week 19))
  • Change in the Social responsiveness scale - Second Edition (SRS-2)(Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74))
  • Change in Emotions via Experience Sampling (ESM)(Through the intervention until follow up time from week 1 to 36)

研究者

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

Sonya Girdler

Associate Professor

Curtin University

研究点 (2)

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