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CTRI Number  CTRI/2025/08/092208 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 18/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Occupational Therapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Improving sleep quality of autistic children using mother mediated multisensory stimulation 
Scientific Title of Study   Effectiveness of Mother Mediated Multi Sensory Stimulation on Sleep quality in Children with Autism Spectrum Disorder. 
Trial Acronym  MSI 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jenifer C 
Designation  Student 
Affiliation  Chettinad School of Occupational Therapy 
Address  Occupational therapy, Pediatrics department, A- block,ward no- 24,4th floor,Chettinad Academy of Research and Education,Chettinad Health City,Rajiv Gandhi Salai(OMR), Kelambakkam.
Occupational therapy, Pediatrics department, A- block,ward no- 24,4th floor, Chettinad Academy of Research and Education,Chettinad Health City,Rajiv Gandhi Salai(OMR), Kelambakkam.
Chennai
TAMIL NADU
603103
India 
Phone  9514800911  
Fax    
Email  jeniferchandran91@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Bhuvaneshwari.S 
Designation  Assistant Professor 
Affiliation  Chettinad School of Occupational Therapy 
Address  Occupational therapy, Pediatrics department, A- block,ward no- 24,4th floor, Chettinad Academy of Research and Education,Chettinad Health City,Rajiv Gandhi Salai(OMR), Kelambakkam.
Occupational therapy, Pediatrics department, A- block,ward no- 24,4th floor,,Chettinad Academy of Research and Education,Chettinad Health City,Rajiv Gandhi Salai(OMR), Kelambakkam.
Kancheepuram
TAMIL NADU
603103
India 
Phone  9840016032  
Fax    
Email  bhuvaneshwaris@care.edu.in  
 
Details of Contact Person
Public Query
 
Name  Jenifer C 
Designation  Student 
Affiliation  Chettinad School of Occupational Therapy 
Address  Occupational therapy, Pediatrics department, A- block,ward no- 24,4th floor, Chettinad Academy of Research and Education,Chettinad Health City,Rajiv Gandhi Salai(OMR), Kelambakkam.
Occupational therapy, Pediatrics department, A- block,ward no- 24,4th floor, Chettinad Academy of Research and Education,Chettinad Health City,Rajiv Gandhi Salai(OMR), Kelambakkam.

TAMIL NADU
603103
India 
Phone  9514800911  
Fax    
Email  jeniferchandran91@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Jenifer C 
Address  Chettinad Academy of Research and Education,Chettinad Health City,Rajiv Gandhi Salai(OMR), Kelambakkam. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Jenifer C  Chettinad Hospital and Research Instituite  Occupational therapy, Pediatrics department, A- block,ward no- 24,4th floor, Chettinad Academy of Research and Education,Chettinad Health City,Rajiv Gandhi Salai(OMR), Kelambakkam.
Chennai
TAMIL NADU 
09514800911

jeniferchandran91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituite Human Ethics Committee for Student Research(CARE IHEC-1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F840||Autistic disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Children Sleep Habits Questionnaire  At the beginning and followed by 8 weeks of intervention sleep quality will be assessed using Children Sleep Habits Questionnaire 
Intervention  Multi Sensory Interention  Multi sensory stimulation will be trained to mother. Researcher and mother will provide intervention. Each session will last 30 minutes, 2 days per week, for 8 weeks will be given. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  ASD children with sleep disturbance of age 4-12- both male and female.
Children diagnosed with ASD as per the Indian Scale for Assessment of Autism (ISAA) with a total score exceeding 153, indicating severe autism.
Sleep concerns- Parental report of sleep disturbance like delayed sleep onset, frequent night awakening or reduced total sleep duration.
 
 
ExclusionCriteria 
Details  Children those who are below the age 7 Children with severe physical impairments that prevent sensory room usage Having any chronic disease that could affect the study (orthopedic, epileptic) 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Children Sleep Habits Questionnaire (CSHQ)  8 weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/08/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by significant impairments in social interaction, communication, and behavior. Children with ASD often experience sleep disturbances, including insomnia, delayed sleep onset, and frequent night awakenings, which can exacerbate core symptoms such as hyperactivity, irritability, and social deficits. These sleep issues are linked to cognitive challenges, including attention deficits, memory problems, and difficulties in emotional regulation. Research indicates that poor sleep quality in children with ASD is associated with increased behavioral problems and can negatively impact family well-being. Addressing sleep disturbances is crucial for improving the overall quality of life for children with ASD and their families. Sensory-based interventions, such as moderate pressure touch or massage, have shown promise in improving sleep quality in children with ASD. Studies have found that moderate pressure massage can have a calming effect, reducing sleep onset latency and night awakenings. For instance, children aged 5–6 years with ASD who received Qigong massage demonstrated improvements in social skills, language, and behavior. Additionally, parental massage interventions have been associated with decreased hyperactivity and impulsivity in children with ASD. These interventions are cost-effective and can be integrated into daily routines, empowering parents to support their child’s sleep and overall development. Despite the potential benefits of sensory-based interventions, there is a lack of research specifically examining the effectiveness of mother-mediated multi-sensory stimulation on sleep quality in children with ASD. This study aims to fill this gap by evaluating the impact of such interventions on sleep patterns and overall well-being in children with ASD.


 
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