| CTRI Number |
CTRI/2026/01/101730 [Registered on: 21/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Parent Guided Behavioral Training on children with Autism |
|
Scientific Title of Study
|
A Randomized Controlled Trial on Parent Mediated Behavioral Intervention in Children with 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 |
ARUNMOZHI DEVI A |
| Designation |
Postgraduate- MD Psychiatry |
| Affiliation |
Institute of Mental Health, Kilpauk |
| Address |
C/O The Director,
Institute of Mental Health,
Medavakkam Tank Road,
Kilpauk, Chennai
Chennai
TAMIL NADU
600010
India |
| Phone |
9790004577 |
| Fax |
|
| Email |
arunmozhidevii@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P P Kannan |
| Designation |
Professor in Psychiatry |
| Affiliation |
Institute of Mental Health, Madras Medical College |
| Address |
Institute of Mental Health,
Medavakkam Tank Road,
Kilpauk, Chennai
Chennai
TAMIL NADU
600010
India |
| Phone |
9444057273 |
| Fax |
|
| Email |
ppkannan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ARUNMOZHI DEVI A |
| Designation |
Postgraduate- MD Psychiatry |
| Affiliation |
Institute of Mental Health, Kilpauk |
| Address |
C/O The Director,
Institute of Mental Health,
Medavakkam Tank Road,
Kilpauk, Chennai
Chennai
TAMIL NADU
600010
India |
| Phone |
9790004577 |
| Fax |
|
| Email |
arunmozhidevii@gmail.com |
|
|
Source of Monetary or Material Support
|
| DHR-ICMR Financial Support for MD thesis program-MDMS24JUN-0336 |
|
|
Primary Sponsor
|
| Name |
ARUNMOZHI DEVI A |
| Address |
C/O The Director,
Institute of Mental Health-Madras Medical College,
Medavakkam Tank Road,
Kilpauk, Chennai-600010 |
| 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 Arunmozhi Devi A |
Madras Medical College |
OP-11, Child guidance clinic, Department of Child and adolescent Psychiarty, Institute of Mental health, Medavakkam Tank road, Kilapuk, Chennai-600010
Chennai
TAMIL NADU |
9790004577
arunmozhidevii@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Madras Medical College |
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 |
Parent Mediated Behavioral Intervention |
Parent will be trained to deliver structured behavioral strategies to their children with Autism Spectrum Disorder, aged 2-4 years. The intervention focuses on enhancing Imitation, Non verbal communication, Visual response, Listening response. Intervention is delivered as one-to-one training sessions for parents over 4 sessions, with practice at home. The duration of intervention is 12 weeks. |
| Comparator Agent |
Standard Care of Treatment |
Standard care of treatment includes visit with treating Psychiatrist, speech, behaviour and occupational therapy. Pharmacological therapy will be decided on case to case basis. |
|
|
Inclusion Criteria
|
| Age From |
24.00 Month(s) |
| Age To |
48.00 Month(s) |
| Gender |
Both |
| Details |
1. Children aged 24 - 48 months diagnosed with Autism Spectrum Disorder based on DSM V TR criteria.
2.Children with comorbid epilepsy and Intellectual Disability is also included.
3.Parents willing to give written informed consent to participate in the study and willing to deliver home based behavioral intervention. |
|
| ExclusionCriteria |
| Details |
1. Children with significant sensory, motor & cognitive impairment interfering with therapy.
2. Children with chronic serious health condition unable to engage in therapy.
3. Children with history of serious head injury, neurological disease, other neurodevelopmental and genetic conditions. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Imitation, Visual Response, Listening Response and Non verbal communication. |
At Baseline and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in behavioral symptoms following intervention. |
At baseline and 12 weeks. |
| Parent satisfaction in home based behavioral intervention |
At 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 1 |
|
Date of First Enrollment (India)
|
20/02/2026 |
| 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) |
Not Yet Recruiting |
|
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
|
The study aims to evaluate the effectiveness of Parent mediated behavioral intervention in improving Imitation, Visual Response, Listening Response and Non verbal Communicationin children aged 2-4 years with Autism Spectrum Disorder in addition to standard care of treatment. The study hypothesis is Children with Autism Spectrum Disorder receiving parent mediated behavioral intervention will show greater improvement in Imitation, Visual Response, Listening Response and Non verbal communication. |