跳至主要内容
临床试验/NCT05857813
NCT05857813招募中不适用

Establishment of Social Skills Training Group in Adolescents With Autism Spectrum Disorder and Effectiveness Analysis

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Autism Diagnostic Interview-Revised (ADI-R)

研究概览

简要总结

Autism spectrum disorders (ASD) is a neurodevelopmental disorder characterized by persistent deficits in social communication and social interaction across multiple contexts, and the presence of restricted, repetitive behavior and interests, affecting 1 in 68 children. Although atypical social deficits onset in early childhood, their social relationships with peers may remain a challenge or even worsen for individuals with ASD throughout the school years and beyond, as social contexts increase in complexity and pose higher social expectations.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
11 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • aged 11-20 years, currently enrolled in school between the sixth grade of elementary school and the third year of high school
  • with a clinical diagnosis of ASD from a licensed mental health or medical professional based on DSM-5
  • experiencing social difficulties as reported by parents in a structured intake interview
  • scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD
  • demonstrating verbal fluency in Chinese
  • with a full-scale IQ > 70 on WAIS-IV
  • with motivation to participate in the intervention;
  • with a caregiver who was fluent in Chinese and willing to participate as a social coach in the study.

排除标准

  • a history of major mental illness (e.g., bipolar affective disorder, schizophrenia, or psychosis) or neurological diseases that might hinder participation in the treatment
  • visual impairment and/or hearing impairment that would preclude participation in group-based social activities.

研究组 & 干预措施

ASD teens and their caregiver

Experimental

Teens: (1) aged 11-20 years, currently enrolled in school between the sixth grade of elementary school and the third year of high school; (2) with a clinical diagnosis of ASD from a licensed mental health or medical professional based on DSM-5; (3) experiencing social difficulties as reported by parents in a structured intake interview; (4) scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD (5) demonstrating verbal fluency in Chinese (6) with a full-scale IQ > 70 on WAIS-IV; (7) with motivation to participate in the intervention; (8) with a caregiver who was fluent in Chinese and willing to participate as a social coach in the study.

Parents: (1) demonstrating verbal fluency in Chinese (2) with motivation to participate in the intervention and assist their children to do the homework assignments.

干预措施: Program for the Education and Enrichment of Relational Skills (PEERS®) (Behavioral)

结局指标

主要结局

Autism Diagnostic Interview-Revised (ADI-R)

时间窗: 7 weeks

Interview with caregiver of autistic participants. Total of 93 items coding from 1 to 9. Higher the score, worse the syptom

The Autism Diagnostic Observation Schedule (ADOS)

时间窗: 7 weeks

Observe the autistic participant during the interview. the examinee's condition is classified as autism spectrum if the combined score across two domains of social interaction and communication is ≥7, and as autism if the combined score is ≥12. In Module 2, a combined score of ≥8 corresponds to autism spectrum, and a combined score of ≥12 corresponds to autism

Friendship Quality Scale (FQS)

时间窗: 7 weeks

23 questions scoring from 1 to 5. Higher the score, better the quality of friendship

The Assessing Emotions Scale (AES)

时间窗: 7 weeks

score range from 33 to 165. higher the score, better the emotional intelligence

Social Responsiveness Scale (SRS)

时间窗: 7 weeks

65 questions range from 1 to 4. higher the score, worse the symptom.

Friendship Questionnaire (FQ)

时间窗: 7 weeks

score from 0 to 135. higher the score, the more enjoyment of friendship

Autism Spectrum Quotient (AQ)

时间窗: 7 weeks

50 statement scoring from 1 to 4. higher the score, worse the syptom

Social Adjustment Inventory for Children and Adolescents (SAICA)

时间窗: 7 weeks

17 scenarios scoring from 1 to 4. Higher the score, better the capability

Quality of Play Questionnaire (QPQ)

时间窗: 7 weeks

10 questions scoring from 0 to 3. Higher the score, worse the quality of play. Also, asked for frequency and number of participant in the play

Test of Adolescents Social Skills Knowledge (TASSK)

时间窗: 7 weeks

score range from 0 to 22. Higher the score, greater the knowledge of taught social skills

Empathy Quotient (EQ)

时间窗: 7 weeks

60 questions score from 0 to 3. Higher the score, greater the empathy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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