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Clinical Trials/CTRI/2022/12/048222
CTRI/2022/12/048222Not yet recruitingNot Applicable

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

Dr. Advaita Sini Achan6 sites in 1 country144 target enrollmentStarted: December 26, 2022Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
144
Locations
6
Primary Endpoint
Children Sleep Habits Questionnaire for Parents

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
4.00 Year(s) to 10.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Children Sleep Habits Questionnaire for Parents

Time Frame: The study is a one time case control study

Secondary Outcomes

  • NA(NA)

Investigators

Sponsor
Dr. Advaita Sini Achan
Sponsor Class
Other [self]

Study Sites (6)

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