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
|
|
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
|
|
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. |