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CTRI Number  CTRI/2023/05/052869 [Registered on: 18/05/2023] Trial Registered Prospectively
Last Modified On: 05/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Intervention protocol for 6 – 12 years children with Autism Spectrum Disorder  
Scientific Title of Study   Development of an intervention protocol for children with Autism Spectrum Disorder aged 6 – 12 years 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Monica Juneja 
Designation  Director Professor and Head 
Affiliation  Maulana Azad Medical College and associated Lok Nayak Hospital 
Address  Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, 2 Bahadur Shah Zafar Marg, New Delhi
2 Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India 
Phone    
Fax    
Email  drmonicajuneja@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Monica Juneja 
Designation  Director Professor and Head  
Affiliation  Maulana Azad Medical College and associated Lok Nayak Hospital 
Address  Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, 2 Bahadur Shah Zafar Marg, New Delhi

Central
DELHI
110002
India 
Phone    
Fax    
Email  drmonicajuneja@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Monica Juneja 
Designation  Director Professor and Head  
Affiliation  Maulana Azad Medical College and associated Lok Nayak Hospital  
Address  Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, 2 Bahadur Shah Zafar Marg, New Delhi

Central
DELHI
110002
India 
Phone    
Fax    
Email  drmonicajuneja@gmail.com  
 
Source of Monetary or Material Support  
National Health Mission (NHM) Directorate of Family Welfare, Govt. of NCT of Delhi, B’ & C Wing, 7th Floor, Vikas Bhawan- 2, Civil Lines, New Delhi – 110054 
 
Primary Sponsor  
Name  Dr Monica Juneja 
Address  Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, 2 Bahadur Shah Zafar Marg, New Delhi 110002 
Type of Sponsor  Other [(Self)] 
 
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 
Dr Monica Juneja  Centre of Excellence – Early Intervention Centre  Special Ward Block, Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi 110002
Central
DELHI 
9968604311

drmonicajuneja@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional 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 
Intervention  Caregiver administered protocolized behavioral intervention program  Trial participants will be trained using a behavioral intervention program specifically designed for the study.A checklist designed for the study will be administered to the children at enrolment for identifying skills to be taught. Caregivers will be trained to give the intervention in the childs natural environment, as per the intervention protocol designed in the first phase of the trial.Intervention will be for a duration of 1 year, wherein child along with primary caregiver will receive one-to-one sessions with therapist every 3 weeks. intervention demonstrated and reinforced during the visit will be continued by the primary caregiver at home. In addition, participants will receive group sessions every week. 
Comparator Agent  Treatment as usual  Trial participants will receive a combination of therapies including behavior modification, speech therapy and special education as per the standard unit protocol for a duration of 1 year 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children aged 6 to 12 years diagnosed with Autism Spectrum Disorder by DSM-V criteria having a mental age more than or equal to 3 years and functional speech of at least 3-word sentences with
i)The primary caregiver willing to attend training sessions on specified dates, during the study period.
ii)Primary caregiver willing to spend at least 3 hours daily with their child for therapy related activities, during the study period.
 
 
ExclusionCriteria 
Details  1.Children with co-morbid neurodevelopmental disabilities, namely cerebral palsy, significant hearing impairment, significant visual impairment, poorly controlled seizures or neuro degenerative disorders.
2.Children with chronic systemic illnesses like chronic lung disease, chronic liver disease, congenital heart disease etc.
3.Children with syndromic ASD
4.Primary caregiver doesn’t understand either Hindi or English.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Difference between mean change in SRS-2 score between the two groups   Baseline, and after 1 year of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
1.Difference between mean change in CARS-2 score
2.Difference between mean change in VABS-3 score
3.Difference between mean change in Development Quotient (DQ)/ Intelligence Quotient (IQ)
4.Difference between mean change in LPT scores/ REELS scores
 
1 year after enrolment 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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)   01/03/2024 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
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 disorder characterized by persistent deficits in social communication and social interaction and the presence of restricted, repetitive patterns of behavior, interests, or activities which impacts an individual across lifespan. Early diagnosis and timely initiation of evidence based therapies have shown to optimize developmental outcomes. Children with autism spectrum disorder above 6 years of age require a different skill set than toddlers and pre-schoolers to deal with the socializing element of life and to better adapt to the forthcoming academic demands. However, studies on interventions in children with ASD have largely focused on early intervention in toddlers and preschool age children and only few have evaluated the interventions for children with ASD beyond 6 years of life.

As established by research, children with ASD are educable and outcomes depend on timely institution of early interventions. As these children transition from toddler and preschool ages to childhood, they face differing challenges and difficulties, requiring a change in intervention strategies. Involvement of families and caregivers is vital for enabling continuation of therapies especially in a resource limited country like India, where there is a shortage of trained therapists. Since there is a paucity of studies evaluating interventions and their outcomes specifically for children aged 6-12 years, this study was planned. We intend to develop a caregiver mediated intervention protocol for children with Autism Spectrum Disorder of age 6-12 years and compare its efficacy with standard care.

 
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