| 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
|
|
|
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
|
|
|
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
|
|
|
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.
|