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CTRI Number  CTRI/2026/02/103119 [Registered on: 05/02/2026] Trial Registered Prospectively
Last Modified On: 05/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Play based occupational therapy]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study on improving Quality of Life in Children with Attention and hyperactivity difficulties using play based occupational therapy 
Scientific Title of Study   Effectiveness of play based occupational therapy intervention on quality of life among 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  G PRIYANKA 
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  9994170655  
Fax    
Email  priyankagopinatha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr B Nibedita Priyadarshinee 
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, Kelambakkam, Chennai, Tamil Nadu, India - 603103

Kancheepuram
TAMIL NADU
603103
India 
Phone  9778736107  
Fax    
Email  priyadarshineeb@care.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr B Nibedita Priyadarshinee 
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, Kelambakkam, Chennai, Tamil Nadu, India - 603103

Kancheepuram
TAMIL NADU
603103
India 
Phone  9778736107  
Fax    
Email  priyadarshineeb@care.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  G Priyanka 
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  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr B Nibedita Priyadarshinee  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 		 9778736107

priyadarshineeb@care.edu.in 
 
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  
Status 
Not Applicable 
 
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  Pediatric Quality of Life Inventory Peds QL  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  Play- based occupational therapy  Prior to the initiation of the study, ethical approval will be obtained from the Institutional Review Board of Chettinad University Hospital CHRI, CARE. Before enrolling each child, written informed consent will be obtained from the parents or legal guardians, and age appropriate assent will be obtained from the children. A total of 50 children aged 5 to 10 years diagnosed with ADHD will be recruited from the Occupational Therapy Department of Chettinad Hospital and Clinics, located in Chengalpattu District. Participants will be selected using a convenience sampling method. Initial screening will be conducted using the Vanderbilt ADHD Diagnostic Parent Rating Scale to confirm the diagnosis and eligibility according to the inclusion and exclusion criteria. After confirmation of eligibility and completion of consent procedures, the participants will be randomly allocated into two groups: an experimental group consisting of 25 children and a control group consisting of 25 children. Before the commencement of the intervention, a baseline (pre-intervention) assessment of quality of life will be conducted for all participants using the Pediatric Quality of Life Inventory. This assessment will provide information on the physical, emotional, social, and school functioning of the children. The experimental group will receive a structured play-based occupational therapy intervention, which includes figurine-based simulation activities combined with sensory integration techniques. These activities will be designed to enhance attention, self-regulation, participation, and functional performance in daily activities. The intervention will be administered for a duration of 4 weeks, with each session lasting 45 minutes, conducted three days per week. During this intervention period, the control group will continue with their routine care and will not receive any additional intervention from the researcher. At the end of the 4-week intervention period, a post-intervention assessment will be carried out for both groups using the same standardized tool, namely the Pediatric Quality of Life Inventory. The pre- and postintervention scores obtained from both the experimental and control groups will be statistically analyzed to determine the effectiveness of the play-based occupational therapy intervention in improving the quality of life of children with ADHD. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children aged 5 to 10 years with a confirmed clinical diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) based on clinical evaluation and scores within the diagnostic range on the Vanderbilt ADHD Diagnostic Parent Rating Scale (VADPRS) will be included in the study. Children who demonstrate difficulties in daily functioning and are currently receiving occupational therapy services, where required, will also be eligible for participation. Only children with no reported history of other physical illnesses or medical conditions that could interfere with participation in the intervention will be considered for
inclusion  
 
ExclusionCriteria 
Details  Children with neurological disorders, developmental conditions, or psychiatric diagnoses other than ADHD will be excluded from the study. Children younger than 5 years or older than 10 years will not be included. Additionally, children whose VADPRS score fall below the diagnostic range for ADHD will be excluded to ensure homogeneity of the study sample . 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The Study outcome will be measured by using Pediatric Quality of Life Inventory
 		 Quality of life will be assessed using the Paediatric Quality of Life Inventory before the intervention and reassessed after four weeks of play based occupational therapy 
 
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)   16/02/2026 
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 designed to evaluate the EFFECTIVENESS OF PLAY BASED OCCUPATIONAL THERAPY INTERVENTION ON QUALITY OF LIFE AMONG CHILDREN WITH ATTENTION DEFICIT HYPERACTIVE DISORDER .Prior to the initiation of the study, ethical approval will be obtained from the Institutional Review Board of Chettinad University Hospital CHRI, CARE. Before enrolling each child, written informed consent will be obtained from the parents or legal  guardians, and age appropriate assent will be obtained from the children. A total of 50 children aged 5 to 10 years diagnosed with ADHD will be recruited from the Occupational Therapy Department of Chettinad Hospital and Clinics, located in Chengalpattu District. Participants will be selected using a convenience sampling method. Initial screening will be conducted using the Vanderbilt ADHD Diagnostic Parent Rating Scale to confirm the diagnosis and eligibility according to the inclusion and exclusion criteria. After confirmation of eligibility and completion of consent procedures, the participants will be randomly allocated into two groups: an experimental group consisting of 25 children and a control group consisting of 25 children. Before the commencement of the intervention, a baseline (pre-intervention) assessment of quality of life will be conducted for all participants using the Pediatric Quality of Life Inventory. This assessment will provide information on the physical, emotional, social, and school functioning of the children. The experimental group will receive a structured play-based occupational therapy intervention, which includes figurine-based simulation activities combined with sensory integration techniques. These activities will be designed to enhance attention, self-regulation, participation, and functional performance in daily activities. The intervention will be administered for a duration of 4 weeks, with each session lasting 45 minutes, conducted three days per week.During this intervention period, the control group will continue with their routine care and will not receive any additional intervention from the researcher. At the end of the 4-week intervention period, a post-intervention assessment will be carried out for both groups using the same standardized tool, namely the Pediatric Quality of Life Inventory. The pre- and postintervention scores obtained from both the experimental and control groups will be statistically analyzed to determine the effectiveness of the play-based occupational therapy intervention in improving the quality of life of children with ADHD.
 
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