Effects of Routines-Based Early Intervention in Children With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Goal Attainment Scale(GAS)
研究概览
简要总结
Autism Spectrum Disorder (ASD) mainly has social and interaction related problems, and repetitive behaviors or interests. In recent years, studies showed that Routine-Based Early Intervention(RBEI) could increase children's development and enhance skills maintenance. Using the International Classification of Functioning, Disability and Health for Children and Youth (ICF-CY) to assess children can identify different factors under systematic analysis, then improving children's physical functions and self-care abilities. Therefore, this study will design RBEI programs for autistic children, and use ICF-CY to assess the efficacy of RBEIin body function, body structure, and participation for children with autism.
详细描述
Study will enroll 30-40 children with ASD, aged 3-9 years. Children will receive subjective and objective assessment for pre-test, post-test and three-monthfollow-up after treatment. After pre-test, children will be randomized and assigned to either the experimental group or the control group. The experimental group willreceive RBEI and the control group willreceive traditional therapy. The treatment period is 12 weeks, 1-2 times a week, 1-2hours each time, and homework is given during the treatment period, allowing parents to do treatment at home. Post-test will be conducted immediately after the end of treatment period, and homework will continue until three-month follow-up conducts. It is expected that after intervention, the physical function, activities and participation, quality of life of the experimental group will improve and significantly different from the control group.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents are willing to sign written consent form
- •Diagnosed as ASD by doctor
- •No neurological disease
排除标准
- •Active medical condition
- •Progressive or degenerative symptoms or illness
研究组 & 干预措施
MRBI group
干预措施: MRBI (Behavioral)
Control group
干预措施: Control (Behavioral)
结局指标
主要结局
Goal Attainment Scale(GAS)
时间窗: baseline, up to 24hours,3-month FU
It's an individualized assessment tool, setting goals based on the subject's ability and condition, and specifically describe or quantify the progress of the situation, with a view to regularly assessing and understanding whether the subject has progressed or regressed. The scale is a five-point scale from -2 to 2.
Comprehensive Developmental Inventory for Infants and Toddlers(CDIIT)
时间窗: baseline, up to 24hours,3-month FU
Applicable to infants and young children aged 3-71 months. It includes the clinical assessment and the parent-report questionnaires. It is used to evaluate the motor, language, cognition, social self-care and other fields of infants and young children. It has good inter-tester reliability, retest reliability, internal consistency, content validity and construction validity. Considering to the comprehensive developmental capacity of children with autism, we assess the overall developmental capacity of children with autism up to nine years oldin this study.
次要结局
- Childhood Asperger Syndrome Test(CAST)(baseline, up to 24hours,3-month FU)
- The Children Autism Rating Scale Second Edition(CARS-2)(baseline, up to 24hours,3-month FU)
- Clancy Behavior Scale(baseline, up to 24hours,3-month FU)
- Social Responsiveness Scale(SRS)(baseline, up to 24hours,3-month FU)
- Theory of Mind Inventory-2(ToMI-2)(baseline, up to 24hours,3-month FU)
- The Berry-Buktenica Developmental Test of Visual-Motor Integration(VMI)(baseline, up to 24hours,3-month FU)
- Preschool Language Impaired Scale(PLS)/ Language Impaired Scale(LS)(baseline, up to 24hours,3-month FU)
- Peabody Picture Vocabulary Test-Revised(PPVT-R)(baseline, up to 24hours,3-month FU)
- Swanson, Nolan, and Pelham Questionnaire(SNAP)(baseline, up to 24hours,3-month FU)
- Assessment of preschool children's participation(APCP) / Children Assessment of Participation and Enjoyment andPreferences for Activity of Children(CAPE)(baseline, up to 24hours,3-month FU)
- Functional Independence Measure for Children(WeeFIM)(baseline, up to 24hours,3-month FU)
- TNO-AZL Preschool children Quality of Life(TAPQOL)/TNO-AZL Quality of Life Questionnaire(TACQOL)(baseline, up to 24hours,3-month FU)
- Sensory Profile(SP)(baseline, up to 24hours,3-month FU)
- Parenting Stress Index(PSI)(baseline, up to 24hours,3-month FU)