Evaluation of the Effectiveness of a Social Skills Group Intervention Program for Children and Adolescents With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Change from baseline number of social behaviors as measured by an observational instrument at 10 weeks later (after intervention)
研究概览
简要总结
Research evaluating effectiveness of social skills intervention programs for children and adolescents with Autism Spectrum Disorder is still limited.
The main objective of this study was to develop an adaptation of the Social Adjustment Enhancement Intervention program form the University of California for a group of children and adolescents with autism. Our secondary goal was to evaluate the effect of our program through specific indicators. We hypothesized a decrease in comorbid symptomatology, as measured by questionnaires. We also expected an increase in social behaviors, measured through observational methodology.
详细描述
Participants were recruited by psychologists and psychiatrists from a Multidisciplinary Unit for Autism Spectrum Disorder, in accordance the 2000 Helsinki declaration.
A total sample of 94 participants was divided in two age-groups: children (8 to 12 years old) and adolescents (13-17 years old). These groups participated in the study over a three-year period (2017, 2018, and 2019). Each year the investigators recruited approximately 30 participants (children and adolescents). Subjects were paired according to age, gender and intelligence quotient; then each pair was randomized between the two groups (experimental group and waiting list control group) using R software with a fixed random seed.
The experimental group of each year received treatment from January to April. The waiting list control group received the treatment from April to July, after participating in the trial. For both groups, pre-treatment evaluation was performed in January and post-treatment evaluation was done in April. The treatment groups were conducted by one psychologist, two co-therapists (psychiatrists or mental health nurses), and with the assistance of two graduate students in psychology. Fifteen participants were excluded due to missing data.
Materials and design Diagnostic instruments The Autism Diagnostic Observation Schedule-2 was administered to all participants. To be included in the study, participants had to score above the cut-off point. Intellectual abilities and verbal comprehension were measured with the Wechsler Intelligence Scale for Children and Adolescents.
Outcome measurement instruments
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age range between 8 and 17 years old
- •confirmed diagnosis of autism spectrum disorder according to Diagnostic and Statistical Manual, fifth version (APA, 2013)
- •meeting cut-off at the Autism Diagnostic Observation Schedule-2 (ADOS-2, Lord et al., 2000)
- •normal range of Verbal Comprehension.
排除标准
- •severe behavioral problems
- •several mental psychopathologies such as schizophrenia
- •intellectual functioning below 80.
结局指标
主要结局
Change from baseline number of social behaviors as measured by an observational instrument at 10 weeks later (after intervention)
时间窗: Change from Baseline number of social conducts at 10 weeks later (after intervention)
In order to quantitatively code social behaviors, we applied an observational instrument. First of all, we reorganized and developed an observational instrument inspired by a previous observational instrument and by the approach of social difficulties of the authors of Autism Diagnosis Observational Schedule-2. This instrument allows the observer to quantify the number of occurrences of target behaviors according to pre-established categories. The scale includes six defined dimensions and category systems that meet the requirements of exhaustively and mutual exclusivity.
次要结局
- Change from baseline results in The Spence Children's Anxiety Scale (SCAS): (Spence, 1997):(Change from Baseline anxiety symptoms to 10 weeks later (immediately after the intervention))
- Change from baseline results in Child Behavior Checklist (CBCL/6-18): (Achenbach, T. 1992)(Change from Baseline comorbid symptoms to 10 weeks later (immediately after the intervention))