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CTRI Number  CTRI/2025/01/078844 [Registered on: 16/01/2025] Trial Registered Prospectively
Last Modified On: 31/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of music therapy on social skills 
Scientific Title of Study   Efficacy of Music Therapy on Social Competence in Children with Autism Spectrum Disorder- A Randomised Control Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Snigdha Chand 
Designation  Junior Resident of Psychiatry 
Affiliation  All India Institute Of Medical Sciences ,Patna 
Address  Child Guidance Clinic ,OPD Building ,D Block, Department Of Psychiatry All India Institute of Medical Sciences, Phulwarisharif ,Patna
Child Guidance Clinic, OPD Building , D Block ,Department of Psychiatry , All India Institute of Medical Sciences , Phulwarisharif , Patna
Patna
BIHAR
801507
India 
Phone  8650788606  
Fax    
Email  dc463429@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajeev Ranjan 
Designation  Associate professor 
Affiliation  All India Institute Of Medical Sciences Patna 
Address  Child Guidance Clinic Department Of Psychiatry AIIMS Patna

Patna
BIHAR
801507
India 
Phone  9717531800  
Fax    
Email  drrajeevranjan@aiimspatna.org  
 
Details of Contact Person
Public Query  
Name  Dr Rajeev Ranjan 
Designation  Associate professor 
Affiliation  All India Institute Of Medical Sciences Patna 
Address  Child Guidance Clinic Department Of Psychiatry AIIMS Patna

Patna
BIHAR
801507
India 
Phone  9717531800  
Fax    
Email  drrajeevranjan@aiimspatna.org  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Phulwarisharif , Patna ,Bihar, India, Pin: 801507 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [Trial is a part of student PG Thesis] 
 
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 
Snigdha Chand  All India Institute of Medical Sciences, Phulwarisharif, Patna, Bihar, India  Child Guidance clinic OPD Block Room no 522,Fifth Floor, under Department of Psychiatry All India Institute of Medical Sciences Patna ,Bihar, India, Pin 801507
Patna
BIHAR 		 8650788606

dc463429@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Patna  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 
Intervention  Music Therapy plus standard of care  4 hours thrice a week of standard of care and Half an hour thrice a week of music therapy. The music therapy protocol will be based upon Nordoff and Robbins Music therapy. The primary focus of the therapy is to engage each child in music making. In NRMT therapists work at a time with an individual client to engage in spontaneous musical interactions with instruments or the voice .The focus for the first stage in music therapy is to create a safe space and assisting each child to create a non-verbal relationship with music and the musical environment. The second stage is characterized by the childs beginning of acceptance of the music therapist and his use of voice for self-expression is to engage each child in music making. Total 24 sessions will be required for the music therapy in duration of 8 weeks.Total duration of Music Therapy will be 12 hours within the period of 8 weeks and total duration of standard of care will be 96 hours within the period of 8 weeks. 
Comparator Agent  Standard of Care  Standard of Care involves Pre requisite learning skills with behavioral intervention, Speech stimulation techniques, Occupational therapy session. It will also include Group sessions, Break session which focusses upon enhancing the ADL.4 hours thrice a week of standard of care will be given for 8 weeks in both groups. Additionally family members will be psycho-educated and standard of care will be also provided by parents in home based settings.Total duration of Standard of Care will be 96 hours within the period of 8 weeks.  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  All children clinically diagnosed with ASD according to DSM 5
Children with ASD with age range 2-6 years
Able to attend sessions continuously with no more than four absences
 
 
ExclusionCriteria 
Details  Significant medical or sensory or motor impairments
A traumatic head injury or neurological condition
Developmental quotient less than 70
Already on therapy with improvement in social emotional skill
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in CDDC Social Competence Score from baseline after 8 weeks of music therapy plus SOC VS SOC  0,8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in other developmental domain score measured by CDDC Score from baseline after 8 weeks of music therapy plus SOC VS SOC.


 		 0, 8 Weeks 
Change in Sensory profile score measured by SP2 from baseline after 8 weeks of music therapy plus SOC VS SOC.
 		 0,8 weeks 
Change in symptom severity score score measured by ISSA from baseline after 8 weeks of music therapy plus SOC VS SOC.
 		 0,8 weeks 
To evaluate the change in play behaviour score measured by change in ChiPPA score post musical therapy plus SOC VS SOC.  0,8 weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   01/03/2025 
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="6"
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  
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Background

Autism Spectrum disorder is a neuro-developmental condition of childhood characterized by qualitative impairment in social and communicative behaviour. There are different modalities that can be used in therapy for autism :one such intervention that can be applied in children with autism is music therapy. Music is a domain of preserved skills and interest in ASD. Music Therapy is a form of clinical application of music and its element as a therapeutic medium to address cognitive, developmental and adaptive and rehabilitative goals in the areas cognitive , psychosocial , language ,sensory and motor functions in individuals with disabilities. The present protocol aims to assess the efficacy of music therapy in social competency in children with ASD. This Study aims to assess the efficacy of Music Therapy in social competence .It will be    tested in our cultural context with Music Therapy Protocol indigineous model and will be assessed with instruments developed in India (CDDC and ISAA).

Objectives

Primary objective-

       To  compare  the change in social skill score (measured by change in CDDC score) from baseline after 8 weeks with Music therapy plus Standard of Care (SOC) versus SOC in Children with Autism Spectrum disorders.

Secondary objective-

·        To compare the change in other domains (measured by change in CDDC scores) from baseline after 8 weeks with Music therapy plus standard of care vs standard of care

·     To compare the change in Sensory Profile score (measured by change in SP-2  score) from baseline after 8 weeks with Music therapy plus standard of care vs standard of care

·       To compare the change in symptom severity score (measured by change in Indian Scale for Assessment of Autism) from baseline after 8 weeks treatment with Music therapy  plus standard of care vs standard of care . In children with Autism spectrum disorder;

 

Methods

This study is a Randomised Control Trial .Children with Autism Spectrum Disorder who are already being diagnosed based on the DSM 5 criteria  are selected based on the inclusion and exclusion criteria. There will be a baseline application of  CDDC, ISSA , SP-2. Children will be Allocated into two groups ,one getting music therapy and standard of care and the other group getting standard of care. Primary and Secondary outcome assessment will be done.and analysis will be done as per ITT , PP. After 8 weeks of the therapy the children will be  clinically assessed using CDDC , ISSA, SP2.

Expected outcome

Music therapy is expected to improve social skills and emotional expression in children with autism spectrum disorder and therefore may be recommended later on as  therapy in these children, if found effective.

 
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