The Efficacy of EMDR in Youngsters With Autism: an Explorative Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in autism symptoms
研究概览
简要总结
Rationale: Currently, for youngsters there is no treatment available that directly targets the core symptoms of autism. EMDR is hypothesized to improve the core symptoms of ASD by reducing the generally high stress levels experienced during social interactions, and increasing the functional connectivity in neuronal networks associated with executive functioning and limbic circuitry.
Objective: The primary objective of the study is to determine if EMDR reduces the core symptoms of ASD and daily experienced stress in youngsters diagnosed with ASD.
Study design: Longitudinal multiple single case studies. Study population: Youngsters aged 12-21 years who are diagnosed with ASD and have a full-scale IQ of 80 or more (N=20).
Intervention: 10 weekly EMDR sessions.
Main study parameters/endpoints: The main endpoint of the study are autism symptoms, which will be assessed using the Social Responsiveness Scale (SRS-A) and the Autism Diagnostic Observation Schedule (ADOS 2). The SRS-A will be administered prior, during and after treatment. The ADOS 2 will be administered prior to treatment and after treatment completion. In addition, we will also administer the Trauma Symptom Investigation Form in Autism Spectrum Disorders (TIF-ASD) questionnaire prior to, during, and after treatment. Furthermore, to answer more fundamental questions concerning the working mechanism of EMDR in ASD, other secondary outcome measures (i.e. PSS-10, AWMA-2) will be included.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants are expected to benefit from treatment. The risks associated with study participation are considered negligible and the burden associated with participation is estimated as low.
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
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with ASD (with or without comorbid psychiatric disorders, except PTSD and anxiety disorders)
- •Full-scale IQ of 80 or more
- •Able to understand and speak Dutch
排除标准
- •Receiving other treatments than medication on a stable dosage.
- •PTSD or other comorbid psychiatric disorders that require immediate and continuous treatment.
研究组 & 干预措施
Intervention
EMDR treatment
干预措施: Eye Movement Desensitization and Reprocessing (EMDR) (Other)
结局指标
主要结局
Change in autism symptoms
时间窗: 0, 1, 2, 3 weeks before intervention; week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 of intervention; 1 and 12 weeks after intervention
Change in autism symptoms is assessed with the SRS-A, which measures youngsters' ability to engage in reciprocal social behaviour in natural social settings, among all domains of autistic symptoms. The SRS-A consist of 5 subscales: 1) Social Awareness, 2) Social Cognition, 3) Social Communication 4) Social Motivation, and 5) Autistic Mannerisms. In total the five subscales comprise 65-items that are answered on a 4-point scale ranging from never true to almost always true. Completion of the questionnaire takes about 15 minutes. The SRS-A is completed by both parents and youngsters separately. Considering that SRS-A scores provided by youngsters are likely to be less reliable, the total score of the parents will serve as the primary outcome measure. In a secondary analysis, the total score of the youngsters will be used to determine the extent to which they perceive EMDR as an effective treatment.
次要结局
- Change in disease severity(3 weeks before intervention; 1 and 12 weeks after intervention)
- Change in general well-being(3 weeks before intervention; 1 and 12 weeks after intervention)
- Change in experienced stress(0, 1, 2, 3 weeks before intervention; week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 of intervention; 1 and 12 weeks after intervention)
- Change in working memory capacity(3 weeks before intervention; 1 week after intervention)