| CTRI Number |
CTRI/2022/12/048222 [Registered on: 19/12/2022] Trial Registered Prospectively |
| Last Modified On: |
06/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Sleep Habits of Children with Autism Spectrum Disorder and Typical Children. |
|
Scientific Title of Study
|
Sleep Habits of Children with Autism Spectrum Disorder and Typically Developing Children. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Advaita Sini Achan |
| Designation |
Student researcher studying Masters of Occupational Therapy in Developmental Disabilities |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal, Karnataka, India.
Udupi
KARNATAKA
576104 India
Udupi
KARNATAKA
576104
India |
| Phone |
8296375064 |
| Fax |
|
| Email |
advaita.mcoahsma@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Banumathe K R |
| Designation |
Guide |
| Affiliation |
MCHP, MAHE |
| Address |
Department of Occupational Therapy MCHP,
MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
banumathe.kr@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Banumathe K R |
| Designation |
Guide |
| Affiliation |
MCHP, MAHE |
| Address |
Department of Occupational Therapy MCHP,
MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
banumathe.kr@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Asha Nilaya school
Near Lombard Memorial Hospital Shanthinagar, Udupi |
| Chethana Special School
Andrathl Seva Mandal Trust behind of Sri Krishna, Kshethra, Anekere, Karkala, Udupi
|
| Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal, Karnataka, India. |
| Karunya Special School
Kadekar kudrukere Post, Malpe, Udupi |
| Manasa Rehabilitation and Training Centre
KARNAIARA
Udupl
Post Padubelle Via Shiva Pamboor
574116
|
| Milagres English Medium High School
Santhekatte, Udupi, Karnataka |
| Trinity Central School
Parampall, Shivall, Udupi |
|
|
Primary Sponsor
|
| Name |
Dr. Advaita Sini Achan |
| Address |
Department of Occupational Therapy MCHP,
MAHE, Manipal. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sr Shanti Prameela BS |
Milagres English Medium High School |
Santhekatte, Udupi, Karnataka
Udupi
KARNATAKA |
08202581410
milagrespryschool@gmail.com |
| Jayavijaya Kumari |
Asha Nilaya school |
Near Lombard Memonal Hospital Shanthinagar
Udupi
KARNATAKA |
9448725305
ashaschool1981@gmail.com |
| Raghunath Shetty |
Chethana Special School |
Bharathi Seva Mandal trust Behind Sri Krishna Kshethra, Anekere, Karkala
Udupi
KARNATAKA |
9448725305
chethanaspecialschool@yahoo.in |
| Mrs Agnes Kunder |
Karunya Special School |
Kadekar Kudrukere Post, Malpe
Udupi
KARNATAKA |
9742352647
karunyaspschool@gmail.com |
| Sr Ancilla Fernandes |
Manasa Rehabilitation and Training Centre |
Post Padubelle Via Shiva Pamboor 3/4116
Udupi
KARNATAKA |
9742352647
manasa_pamboor@yahoo.co.in |
| Fr Dominic Sunil Lobo |
Trinity Central School |
Parampalli, Shivali
Udupi
KARNATAKA |
9606356369
trinityicse@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-2 (Student Research) |
Approved |
| School Permissions |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parents/Caregivers of children with ASD and Parents/Caregivers of typically developing children |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
Parents of children with other developmental disorder
Parents with any psychiatric illness as per the school report. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Children Sleep Habits Questionnaire for Parents |
The study is a one time case control study |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/12/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |