Comparison of Effectiveness of Home Based Sensory Interventions Along With Standard Therapy Versus Standard Therapy Alone in Autistic Children With Sensory Processing Abnormalities :An Open Label Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 1. Comparison of change in total score on 10 item Likert scale (as rated by parents)
研究概览
简要总结
Around 69-95% of children with Autistic Spectrum Disorder are known to have sensory processing abnormalities .Tackling these problems would help in better quality of life, both for the parents and the children. Sensory integration therapy, an individualized clinic based therapy have been shown to have a positive effect on those children with sensory abnormalities. Hence the investigators are doing this study , to primarily look into the efficacy and feasibility of home based sensory interventions in autistic children with sensory processing abnormalities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the age group of 3-12years with autistic spectrum disorder as per DSM -V criteria along with CARS and those having sensory abnormalities as screened by short sensory profile 2 will be included in the study group
- •Parents who agreed for home based sensory intervention therapy with strict adherence to same and to refrain from initiation of any new treatments including medications during study period
排除标准
- •Children with epileptic syndromes with language regression(LKS)
- •Children with features of ASD but having underlying structural(TS), neurometabolic or primary epilepsy as etiology
- •Children with uncontrolled seizures (seizures in the last 06 months)
- •Children whose parents do not give consent for the study
- •Children for whom follow up would not be feasible
研究组 & 干预措施
Intervention group
Children would receive both standard therapy and home based sensory interventions as described below,
- Standard therapy - children would receive measures like speech and language services, behavioral interventions and educational program regularly as and when decided by the primary care physician. They would be individualized to child specific needs .
- Home based sensory interventions - children would receive home based sensory interventions targeting visual and auditory system, tactile abnormalities, proprioceptive and vestibular abnormalities.These interventions would be carried out daily , at least 5 days a week, for a minimum duration of 1hour/day.
干预措施: Sensory interventions (Other)
Control group
This group of children would receive only standard therapy as described below, Standard therapy - children would receive measures like speech and language services, behavioral interventions and educational program regularly as and when decided by the primary care physician. They would be individualized to child specific needs.
结局指标
主要结局
1. Comparison of change in total score on 10 item Likert scale (as rated by parents)
时间窗: 3 months
次要结局
- 1. Comparison of change in health related quality of life using PedsQL ( Pediatric quality of life inventory) questionnaire(3 months)
- 2. Comparison of change in overall functional outcome using CGAS (Children's global assessment scale) questionnaire(3 months)
研究者
Dr Hansashree P
Senior resident , pursuing DM Pediatric neurology
Post Graduate Institute of Medical Education and Research, Chandigarh