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CTRI Number  CTRI/2021/03/031764 [Registered on: 08/03/2021] Trial Registered Prospectively
Last Modified On: 18/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Emotional Intervention for Children with Autism 
Scientific Title of Study   Development of Emotional Enhancement Intervention for Children with Autism Spectrum Disorder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sagayaraj K 
Designation  PhD Research Scholar 
Affiliation  Chettinad Academy of Research and Education (CARE) 
Address  Counseling Psychology, Faculty of Allied Health Sciences, Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education,
Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam, Chengalpet District
Chennai
TAMIL NADU
603103
India 
Phone  7358370695  
Fax    
Email  harrysagayaraj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr C N Ram Gopal 
Designation  Professor of Counseling Psychology, 
Affiliation  Chettinad Academy of Research and Education (CARE) 
Address  Counseling Psychology, Faculty of Allied Health Sciences, Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education,
Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam, Chengalpet District
Chennai
TAMIL NADU
603103
India 
Phone  9444290841  
Fax    
Email  ramgopalgopi59@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr C N Ram Gopal 
Designation  Professor of Counseling Psychology, 
Affiliation  Chettinad Academy of Research and Education (CARE) 
Address  Counseling Psychology, Faculty of Allied Health Sciences, Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education,
Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam, Chengalpet District
Chennai
TAMIL NADU
603103
India 
Phone  9444290841  
Fax    
Email  ramgopalgopi59@gmail.com  
 
Source of Monetary or Material Support  
Chettinad Academy of Research and Education, Junior Research Fellowship 
 
Primary Sponsor  
Name  Chettinad Academy of Research and Education Junior Research Fellowship 
Address  Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam, Chengalpet Dist,Chennai, Tamil Nadu, 603 103 India. 
Type of Sponsor  Research institution and hospital 
 
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 
S Karthikeyan  National Institute for Empowerment of Persons with Multiple Disabilities (Divyangjan)(NIEPMD)  Department of Clinical Psychology, Behaviour Therapy Hall, Ground Floor, Room Number -5, East Coast Road, Muttukadu, Kovalam Post,
Chennai
TAMIL NADU 
9884182257

karthikeyan.clinpsy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chettinad Academy of Research and Education – Institutional Human Ethics Committee  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  Cognitive Behavioural Intervention  Cognitive behavioral therapy may be a treatment option for children with autism spectrum disorder who have other mental health conditions, such as anxiety, depression, or attention deficit hyperactivity disorder. 
Intervention  Emotional Enhancement Intervention   A case-control experimental design with a sample of 34 children who are diagnosed with Autism Spectrum Disorder (both male and female) between the age of 4-10 years will be participating in the study. The selected 34 participants will be randomly divided into two groups namely, control group 17 children who will be given intervention on cognitive and behavioural aspects. Whereas the experimental group, 17 children will be undergoing intervention on cognitive, behavioural, and emotional aspects. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Age – 4 to 10 years, Intelligent quotient – 70 and above, The child with a minimum level of verbal communication, The child with a mild level of autism spectrum disorder, Children with parent/guardian will be included.
 
 
ExclusionCriteria 
Details  Children in the category of the moderate and severe level of autism,
Children with any co-morbid condition such as Intellectual Disability, Attention Deficit Hyperactivity Disorder, Childhood psychosis, Visual impairment, Children who do not have primary caregivers.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Through the developed intervention the adaptive behaviour and emotional reciprocity of children with autism will be empowered.  24 sessions over the period of 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Children with autism find it very hard to perceive and control emotions. Problems in the area of emotional development among children with autism involves (i) Recognising emotions, (ii) Understanding emotions, (iii) Expressing and (iv) regulating emotions which will be addressed and empowered in this intervention.  24 sessions over the period of 6 months 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/03/2021 
Date of Study Completion (India) 30/09/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   No publications yet 
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 developmental disorder that can cause significant impairment in one’s neurological system and affect the individual cognitive, social and emotional condition. International Classification of Diseases (ICD 11) which was developed and released by the World Health Organization (WHO  2018) has given an updated on the criteria for autism. As per the updated ICD 11 guidelines, ASD is characterized as the continues deficiencies in the ability to initiate and continue the social interaction and communication with a range of restricted, repetitive pattern of behaviour. The onset of this disorder occurs in early childhood and tend to continue throughout the person’s life. It severely causes significant impairment in one’s personal, family, and social life. To enable the quality of life of individuals with ASD;  The Rights Of The Persons With Disabilities Act, 2016 which is also called RPWD act 2016 passed in the parliament under The Ministry of Law and Justice in India on December 2016 recognized autism spectrum disorder as one of the 21 disabilities.  It ensures the empowerment of disability individual’s full participation and inclusion in the society with non-discrimination, respect for their different ability and accepting them as a human being. There are many interventions for ASD available in different cultural and environmental settings which range from behaviour, development, medicine and alternative therapy. Some therapeutic interventions combine several different types such as a combination of cognitive behavioural and developmental approaches method. Behaviour-based approaches in ASD focuses on teaching children new behaviour and skills by using behaviour modification techniques. These procedures are the best performing devices for creating abilities and empowering proper behaviour. But emotional regulation is a complex domain requiring the recognition of key elements in social situations and a set of interpersonal and intrapersonal skills. Poor emotional regulation,  social interactions and school engagements in children with ASD may be a result of the deficits in social communication, restrictive/repetitive interests, and behaviour.  The cognitive and behavioural aspects of treating children with ASD by various intervention techniques provided significant improvement in their normal functioning. The advanced research carried out in the medical field on autism contributed a lot in terms of accurate diagnosis and to find the level of functioning such as mild, moderate or severe. All of the above yielded theoretical and empirical evidence for the effort carried out over the decade by numerous mental health professionals but still, it does not provide the comprehensive treatment outcome because of the least focuses on emotional communication. Children with autism frequently find it hard to perceive and control emotions. Their ability in the area of emotional reciprocity can be improved, which thus can assist them with comprehension and react in an appropriate way to different people. As of now, no treatment has been appeared to cure ASD, yet a few interventions have been developed and implemented for the benefit of children with ASD. These interventions may reduce symptoms, improve cognitive ability and daily living functioning, and boost the capacity of the children to work and participate in the social gathering. Research shows that early intervention treatment can altogether improve a child’s general development which I am trying to bring it in the one of the most important domain on human emotion. It assists the child to develop the self-regulation, social relationship and emotional reciprocity with which their overall development can be improved. The emotional domain on children with autism is least focused in terms of interventional aspect hence this study will exclusively focus on the enhancement of emotional regulation in children with ASD.

 
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