| CTRI Number |
CTRI/2025/10/096499 [Registered on: 27/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational Therapy ] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to explore how video peer modeling - showing children with ADHD videos of others children engaging in play - can help improve their play skills |
|
Scientific Title of Study
|
The Effect of Video Peer-Modeling for Playfulness in Children with Attention Deficit Hyperactivity 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 |
Esha K Nair |
| Designation |
Postgraduate Student (MOT) |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences
Sector-C Vasant Kunj , New Delhi
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences
Sector-C Vasant Kunj , New Delhi
South West
DELHI
110070
India |
| Phone |
7738940193 |
| Fax |
|
| Email |
eshanair1710@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lipika Malik |
| Designation |
Assistant Professor |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences
Sector-C Vasant Kunj , New Delhi
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences
Sector-C Vasant Kunj , New Delhi
South West
DELHI
110070
India |
| Phone |
9999931199 |
| Fax |
|
| Email |
lipika.otist@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Esha K Nair |
| Designation |
Postgraduate Student (MOT) |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences
Sector-C Vasant Kunj , New Delhi
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences
Sector-C Vasant Kunj , New Delhi
South West
DELHI
110070
India |
| Phone |
7738940193 |
| Fax |
|
| Email |
eshanair1710@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences
|
|
|
Primary Sponsor
|
| Name |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences |
| Address |
PMR Department Ground Floor
Sector-C Vasant Kunj , New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Esha K Nair |
Indian Spinal Injuries Center |
Indian Spinal Injuries Centre - Institute of Rehabilitation SciencesSector-C Vasant Kunj , New Delhi
Indian Spinal Injuries Centre - Institute of Rehabilitation SciencesSector-C Vasant Kunj , New Delhi
South West
DELHI |
7738940193
eshanair1710@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: F902||Attention-deficit hyperactivity disorder, combined type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A will receive Video peer modeling and Conventional Therapy |
In Video Peer Modeling (25minutes) -Participants will be shown video demonstrations of typically developing peers successfully engaging in different types of play activity followed by real time play activity based on the videos.
After which Conventional Therapy will be provided (20 minutes) and it includes Sensory Integration based different types of playful tactile, vestibular and proprioceptive activities.
Total Duration of each session - 45 minutes
Frequency of sessions - 4 sessions per week for 6 weeks |
| Comparator Agent |
Group B will receive Free Play and Conventional Therapy includes |
In Free play (25 minutes) children will be allowed to engage in play activities with no rules.
After which Conventional therapy (20 minutes) would be provided and it includes sensory integration based different types of playful tactile, vestibular and proprioceptive activities.
Total duration of each session - 45 minutes
Frequency of sessions - 4 sessions per week for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with ADHD
Short Sensory Profile Score lesser than 155-190 i.e. indicating difficulty in sensory processing
Presence of speech i.e. should be verbal
Should be able to follow commands
|
|
| ExclusionCriteria |
| Details |
Children with any uncorrected visual impairments and auditory impairments
Any other pre diagnosed neurological, musculoskeletal, genetic and developmental disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Test of Playfulness |
After six weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
13/11/2025 |
| 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="9"
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
|
Play is the primary occupation of children and is essential for enhancing emotional, cognitive, social, creative and physical development. Play in children with ADHD is often affected by impulsivity, inattention and difficulty with social skills leading to less sustained, less organized and more disruptive play. Video peer-modeling is an approach which can be used for teaching new skills, enhance existing ones. It involves showing customized videos of a peer engaging in the play skills to be taught so that learning can be achieved through observation and imitation.
In this study, the participants will be selected based on inclusion criteria. Study Design will be Experimental and total Sample Size is 30. Participants will be then divided into two groups Group A and Group i.e. 15 participants in each group. Group A will receive Video peer-modeling and Conventional Therapy and Group B will receive Free Play and Conventional Therapy. The training programme will be given for 45 minutes, 4 days a week for 6 weeks.
|