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
|
|
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
|
|
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. |