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CTRI Number  CTRI/2025/12/099221 [Registered on: 16/12/2025] Trial Registered Prospectively
Last Modified On: 15/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Impact of Music Therapy on Language development Communication and Social skills in children with Autism Spectrum Disorder: A Randomized control Trial  
Scientific Title of Study   Impact of music therapy on language developmental, communication,and social skills in children with Autism spectrum disorder 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tejashree Ovhal  
Designation  Undergraduate Student  
Affiliation  Pravara Institute of Medical Sciences-DU 
Address  504 Department Of Pediatric Physiotherapy Dr APJ Abdul Kalam College of Physiotherapy PIMS-DU Maharashtra State India

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9373171659  
Fax    
Email  ovhalteju2311@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepali Hande 
Designation  Professor Head of Department  
Affiliation  Pravara Institute of Medical Sciences-DU 
Address  Dr APJ Abdul Kalam College of Physiotherapy Ahmednagar Maharashtra State India

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8275034001  
Fax    
Email  deepali.hande@pmtpims.org  
 
Details of Contact Person
Public Query  
Name  Tejashree Ovhal 
Designation  Undergraduate Student 
Affiliation  Pravara Institute of Medical Sciences-DU  
Address  504 Department Of Pediatric Physiotherapy Dr APJ Abdul Kalam College of Physiotherapy PIMS-DU Maharashtra State India

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9373171659  
Fax    
Email  ovhalteju2311@gmail.com  
 
Source of Monetary or Material Support  
Paediatric Physiotherapy Department of Dr APJ Abdul Kalam College of Physiotherapy PIMS DU Loni Dist Ahmednagar Taluka Rahata Maharashtra 413736 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
Tejashree ovhal  Dr APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences   OPD no 504 fifth floor Department Of Pediatric Physiotherapy Ahmadnagar Maharashtra
Ahmadnagar
MAHARASHTRA 		 9373171659

ovhalteju2311@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F989||Unspecified behavioral and emotional disorders with onset usually occurring in childhood and adolescence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Music Therapy Pre-Post Single Group Design  Children must be diagnosed with Autism Spectrum Disorder based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. The childs severity must be classified as mild to moderate based on the Childhood Autism Rating Scale, Second Edition (CARS-2). Written informed consent must be obtained from the childs parent or legal guardian prior to enrollment in the study. Children with severe intellectual disability or comorbid neurological conditions, such as epilepsy or cerebral palsy, will be excluded. Children with any significant hearing impairments that could potentially affect their perception of music will also be excluded. Any child with prior participation in structured music therapy programs will be ineligible. Children currently enrolled in intensive behavioral interventions that may act as confounding variables to the study outcomes are excluded. Finally, any child who is currently under any form of medication will be excluded from the study. This is an 8-week music therapy intervention study. Each session will be 35 minutes in duration. The music selection protocol will focus on instrumental pieces, locally relevant music, and contemporary pop songs to maximize engagement and familiarity. Songs with religious themes will be explicitly excluded. The intervention targets improvements in language development, communication, and social skills. 
Comparator Agent  Not applicable  Not applicable  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1)Children’s age 6 to 12 years
2)Children must be diagnosed with Autism Spectrum Disorder (ASD) based on the DSM-5 criteria.
3)The severity level of ASD must be classified as mild to moderate using the Childhood Autism Rating Scale, Second Edition (CARS 2)
4)Written informed consent must be obtained from the child’s parent or legal guardian before enrolling the child in the study. 
 
ExclusionCriteria 
Details  1)Children with severe intellectual disability or comorbid neurological conditions, such as epilepsy or cerebral palsy, will be excluded.
2)Children with any significant hearing impairments that could potentially affect their perception of music will also be excluded. 3)Any child with prior participation in structured music therapy programs will be ineligible.
4)Children currently enrolled in intensive behavioral interventions that may act as confounding variables to the study outcomes are excluded.
5) Child who is currently under any form of medication will be excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Communication
Social skills
Expressive language 		 Week 0 to 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
childhood autism rating scales
communication and symbolic behavior scale
the social responsiveness scale 		 week 0 -week 8 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   26/12/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 is a neurodevelopmental condition characterized by persistent difficulties in social communication and interaction across multiple contexts and restricted repetitive patterns of behavior interests or activities. Music therapy is an established intervention that uses musical elements to address these needs and is commonly explored as a non-pharmacological approach for ASD. This is a single group pre-post design study investigating the impact of structured music therapy on language development communication and social skills in children with ASD. Ten children aged six to twelve years with mild to moderate ASD severity will receive a music therapy intervention consisting of thirty five minute sessions three times per week over a period of eight weeks. The intervention will utilize locally relevant instrumental and popular music to maximize engagement and religious themed songs. Outcomes will be measured using standardized scales such as the Social Responsiveness Scale Second Edition and the Vineland Adaptive Behavior Scales Third Edition at baseline and at eight weeks post intervention. Exclusion criteria include severe intellectual disability and current use of any medication. 
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