跳至主要内容
临床试验/CTRI/2022/12/048222
CTRI/2022/12/048222尚未招募不适用

Sleep Habits of Children with Autism Spectrum Disorder and Typically Developing Children.

Dr. Advaita Sini Achan6 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2022年12月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
144
试验地点
6
主要终点
Children Sleep Habits Questionnaire for Parents

研究概览

简要总结

Approval from the Departmental Research Committee of Occupational Therapy, and the Institutional Research Committee has been obtained. Permission to use the Children Sleep Habit Questionnaire has been given from the author. Permission from the special school and the mainstream schools has been taken. The Children Sleep Habit Questionnaire has been translated. Approval will then be taken from the Institutional Ethics Committee of Kasturba Hospital. Following which, registration will be done in the Clinical Trial Registry of India. The participants will be contacted through the school authorities, they will then be selected according to the selection criteria; the written informed consent will be obtained from the parents of typical children and from the parents of ASD children and they will then be provided with the subject information sheet.

Demographic form, and the CSHQ will then be given to the selected parents through the children during the school hours through the school authorities based on their convenience. Language (English/Kannada) and the mode of communication (google form or a hard copy) will be based on the convenience of the parents. 3 reminders will be given to parents who are yet to return the questionnaire after first 2 weeks. The data will then be collected and analyzed; the results be interpreted followed by manuscript writing and submission of both.

研究设计

研究类型
Observational

入排标准

年龄范围
4.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Parents of children aged 4-10 yrs.
  • who are typically developing and of both the genders.
  • Parents ofthese children who can read and write English or Kannada language.

排除标准

  • Parents of children with other developmental disorder Parents with any psychiatric illness as per the school report.

结局指标

主要结局

Children Sleep Habits Questionnaire for Parents

时间窗: The study is a one time case control study

次要结局

  • NA(NA)

研究者

发起方
Dr. Advaita Sini Achan
申办方类型
Other [self]

研究点 (6)

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