| CTRI Number |
CTRI/2025/03/083171 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing effectiveness of ABA and VBA in children with ASD |
|
Scientific Title of Study
|
A randomised trial to compare the effectiveness of applied behavioural analysis (ABA) and verbal behavioural approach (VBA) in the management of autism spectrum disorder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aaditya Pisharadi |
| Designation |
PG Resident |
| Affiliation |
Indian Navy |
| Address |
Department of Psychiatry, Institue of Naval Medicine, INHS Asvini, Colaba, Mumbai, 400005
Mumbai
MAHARASHTRA
400005
India |
| Phone |
9746557154 |
| Fax |
|
| Email |
pishku.sr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyadarshee Patra |
| Designation |
Professor & HoD Psychiatry |
| Affiliation |
Indian Navy |
| Address |
Department of Psychiatry, Institute of Naval Medicine, INHS Asvini, Colaba, Mumbai, 400005
Mumbai
MAHARASHTRA
400005
India |
| Phone |
9746557154 |
| Fax |
|
| Email |
asvinipsy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Aaditya Pisharadi |
| Designation |
PG Resident |
| Affiliation |
Indian Navy |
| Address |
Department of Psychiatry, Institue of Naval Medicine, INHS Asvini, Colaba, Mumbai, India, 400005
Mumbai
MAHARASHTRA
400005
India |
| Phone |
9746557154 |
| Fax |
|
| Email |
pishku.sr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Naval Medicine, INHS Asvini (INDIAN NAVY), COLABA, Mumbai, INDIA, 400005 |
|
|
Primary Sponsor
|
| Name |
Indian Navy |
| Address |
Institute of Naval Medicine, INHS Asvini, Colaba, Mumbai, India, 400005 |
| Type of Sponsor |
Government medical college |
|
|
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 AADITYA PISHARADI |
INDIAN NAVAL HOSPITAL SHIP Asvini |
Department of Psychiatry, Institute of Naval Medicine, Indian Naval Hospital Ship Asvini, MUMBAI,400005
Mumbai
MAHARASHTRA |
09746557154
pishku.sr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDIAN NAVAL HOSPITAL SHIP ASVINI |
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 |
Applied Behavior Analysis |
Applied behaviour analysis (ABA) refers to the basic theories of behaviour and include the research-based instructional strategies used with (1) Discrete Trial Training (DTT), it is effective for teaching academic and receptive language skills. (2) Pivotal Response Training (PRT), to teach expressive language, play, increasing generalization and social interaction skills and (3) Teaching Functional Routines (FR), daily routines and self-care skills are taught using this strategy. Each child will get one session of one hour per week. |
| Comparator Agent |
Verbal Behaviour Approach |
VBA is a language intervention strategy used to address the language deficits of children with autism spectrum disorders (Skinner, 1957). The teachers use different styles of speech known as “mands,” “tacts,” and “intraverbals” to help the children. Each child will get one session of one hour each per week for 06 months. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
All children visiting the OPD being diagnosed as a case of ASD as per INCLEN-ASD and ICD 11 whose parents are willing to participate and give informed consent and between the Age group of 03 and 06yrs
|
|
| ExclusionCriteria |
| Details |
Children with IQ less than 70 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compare between 02 groups:
severity of autism by ISAA (Indian scale for assessment of autism) |
Baseline and after 06 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| social maturity- Vineland Social Maturity Scale (VSMS) |
baseline & after 06 months |
| adaptive skills- Vineland Adaptive Behavior Scale (VABS). |
baseline & 06 months |
| maladaptive behaviors- Aberrant Behavior Checklist (ABC). |
baseline & after 06 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Study method: i- take informed, written consent ii- assessment with INCLEN-ASD and ISAA done for diagnosing autism spectrum disorder iii- intelligence quotient score will be measured using Seguin Form Board test iv- applying criteria for inclusion and exclusion, the subjects will be included in the study Randomly allot study participants to two groups, ‘A’ and ‘V’ by chit system where group A is to receive ABA and group V is to receive VBA ii- Baseline function deficit in domain of social communication and interaction of child will be measured by Vineland Social Maturity Scale (VSMS), Vineland Adaptive Behavior Scale (VABS), Aberrant Behavior Checklist (ABC). iii- The participants in the ABA group will receive one-on-one sessions with a Clinical psychologist and Psychiatrist. The sessions will focus on teaching adaptive skills and reducing maladaptive behaviors through positive reinforcement and shaping. The participants in the VBA group will receive one-on-one sessions with a Clinical psychologist and Psychiatrist. The sessions will focus on teaching verbal skills and increasing functional communication through positive reinforcement and shaping . Both groups will receive treatment for 6 months. iv- Continue follow-up for a period of 06 months followed by assessment to measure change in autism severity by ISAA, changes in adaptive skills by Vineland Adaptive Behavior Scale (VABS), changes in social maturity by VSMS (Vineland social maturity scale) and changes in maladaptive behaviors, as measured by the Aberrant Behavior Checklist (ABC). |