Genotype and Behavioral Effects of Social Skills Training in Children and Adolescents With High-functioning Autism Spectrum Disorders, a Randomized Controlled Trial (RCT) and Multicenter Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 296
- 试验地点
- 2
- 主要终点
- Social Responsiveness Scale (SRS)
研究概览
简要总结
This trial investigates the behavioral effects of manualized social skills training (KONTAKT) in children´s and adolescents with high-functioning autism spectrum disorder with psychiatric comorbidity in a RCT, multicenter study. N = 288 are recruited from 10 child and adolescent psychiatric clinics in Stockholm County. The examination of genetic variants as predictors for outcome and a qualitative study of KONTAKT complete the trial.
详细描述
There are few randomized controlled trials of social skills group training for the Children's and adolescents with high functioning autism spectrum disorders (HFA)(1). The Objective of this trial is to investigate the behavioral effects of the manualized social skills group training KONTAKT (2,3) and the role of genetic variants for training effects.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Social skills group training KONTAKT
N= 144 participants are offered group training KONTAKT. The intervention includes 12 (brief intervention) and 24 (long intervention) sessions.
干预措施: Social skills group training, KONTAKT (Behavioral)
Control group (TAU), the usual intervention / treatment
N = 144 participants are received treatment as usual (pharmacological therapy, family therapy, Cognitive behavioral therapy etc).
结局指标
主要结局
Social Responsiveness Scale (SRS)
时间窗: Baseline, 3 months after training and 3 months follow-up
Parent and teachers report.
次要结局
- Adaptive Behavior Assessment System II (ABAS II)(Baseline, 3 months after training and 3 months follow-up)
- Developmental Disabilities Modification of the Children's Global Assessment Scale (DD-CGAS)(Baseline, 3 months after training and 3 months follow-up)
- Clinical Global Impression-Improvement/Severity (CGI)(Baseline, 3 months after training and 3 months follow-up)
- Samples With DNA(2 weeks after the beginning of the treatment)
研究者
Sven Bölte
Professor, PhD, head of pediatric neuropsychiatry unit
Karolinska Institutet