| CTRI Number |
CTRI/2026/01/101872 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Virtual Reality Exposure therapy ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Digital based therapy intervention on social participation among children with attention and hyperactivity difficulties |
|
Scientific Title of Study
|
Effectiveness of virtual reality exposure therapy on social participation among children with Attention Deficit Hyperactivity Disorder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajeshwari S |
| Designation |
UG student |
| Affiliation |
Chettinad School of Occupational Therapy |
| Address |
OT pediatric division,Ward No. 24, Department of Occupational Therapy Chettinad General Hospital Chettinad Health City, Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu, India - 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7305180652 |
| Fax |
|
| Email |
rajeshwari21005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vignesh N |
| Designation |
Assistant Professor |
| Affiliation |
Chettinad School of Occupational Therapy |
| Address |
OT pediatric division,Ward No. 24, Department of Occupational Therapy Chettinad General Hospital Chettinad Health City, Rajiv Gandhi Salai OMR
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9750122121 |
| Fax |
|
| Email |
n.vignesh789@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vignesh N |
| Designation |
Assistant Professor |
| Affiliation |
Chettinad School of Occupational Therapy |
| Address |
OT pediatric division,Ward No. 24, Department of Occupational Therapy Chettinad General Hospital Chettinad Health City, Rajiv Gandhi Salai OMR
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9750122121 |
| Fax |
|
| Email |
n.vignesh789@gmail.com |
|
|
Source of Monetary or Material Support
|
| OT pediatric division,Ward No. 24, Department of Occupational Therapy Chettinad General Hospital Chettinad Health City, Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu, India - 603103 |
|
|
Primary Sponsor
|
| Name |
Rajeshwari S |
| Address |
OT pediatric division,Ward No. 24, Department of Occupational Therapy Chettinad General Hospital Chettinad Health City, Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu, India - 603103 |
| 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 |
| DrVignesh N |
CHETTINAD GENERAL HOSPITAL |
OT pediatric division,Ward No. 24, Department of Occupational Therapy Chettinad General Hospital Chettinad Health City, Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu, India - 603103
Kancheepuram
TAMIL NADU |
9750122121
n.vignesh789@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F902||Attention-deficit hyperactivity disorder, combined type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Child and Adolescent Scale of Participation |
The effect of the intervention will be assessed by comparing the results of the pre test collected in the beginning and post test after completing 4 week intervention period. |
| Intervention |
Virtual reality exposure therapy |
Before enrolling each child in the study,
informed consent will be obtained from their patients/guardian, along with assent from the
participants, using consent forms approved by the Institutional Review Board of Chettinad
University Hospital (CHRI, CARE). A total of 50 individuals, aged 4 to 14 years diagnosed with
Attention Deficit Hyperactivity Disorder will be recruited from the Occupational Therapy
Department at Chettinad Hospital and Clinics in the Chengalpattu District . Eligibility will be
confirmed through initial screening using the DSM-5 for ADHD will be assessed through parent
interview. After obtaining consent and confirming inclusion criteria, participants will be
randomly assigned into two groups: an intervention group (n = 25) and a control group (n =
25). Pre- intervention assessment of the independency will be conducted using the Child &
Adolescent Scale of Participation (CASP). The experimental group will receive the Virtual Reality
Exposure while the Control Group will not receive any intervention by researcher during this
time.. Eg: Each session will last 45 minutes, 3 days per week, for 4 weeks. After the 4 weeks
intervention period, the participation will be re-assessed using the same tool; Child &
Adolescent Scale of participation. Pre- and post-intervention scores will be statistically analyzed
to evaluate the effectiveness of the intervention. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
4 to 14 years of age children diagnosed with Attention Deficit Hyperactivity Disorder. |
|
| ExclusionCriteria |
| Details |
Children with other medical and neurological conditions, Autism Spectrum Disorder and children with severe feeding difficulties. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Child and Adolscent Scale of participation |
Social Participation will be assessed using the Child and Adolescent Scale of Participation (CASP)before Intervention (pre intervention) and reassessed after completion of four weeks of Virtual reality exposure therapy intervention (post intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
03/02/2026 |
| 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
|
This study is a randomized, parallel group, active controlled trial evaluating the effectiveness of Virtual reality exposure therapy on social participation among children with Attention Deficit Hyperactivity disorder. A total of 50 individuals aged 4 to 14 years diagnosed with Attention Deficit Hyperactivity Disorder will be recruited from Occupational Therapy Department at Chettinad Hospital and clinics in Chennai and Chengalpattu district. Eligibility will be confirmed using the initial screening using DSM 5 for ADHD will be assessed through patient interview. After obtaining informed consent, participants wil be randomly allocated into two groups: an experimental group (n = 25) and a control group (n = 25), Baseline social participation will be assessed using the Child and Adolscent scale of participation (CASP). The experimental group will receive a Virtual reality exposure therapy intervention consisting of 45-minute sessions, three days per week, for four weeks. The control group will receive no intervention from the researcher during this period. Post-intervention social participation will be reassessed using Child and Adolscent scale of participation (CASP). Pre- and post-intervention scores will be statistically analyzed to determine the effectiveness of the Virtual reality exposure therapy intervention on social participation. |