| CTRI Number |
CTRI/2026/02/103073 [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) [TIMER BASED EXECUSTIVE FUNCTION TRAINING] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Timer-Based Training in Improving Attention and Daily Functioning in Children with Attention and hyperactivity difficulty |
|
Scientific Title of Study
|
Effectiveness of Timer based Executive function training on occupational performance 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 |
Nisma B |
| Designation |
UG-student |
| Affiliation |
|
| 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
Chennai
TAMIL NADU
603103
India |
| Phone |
8148213002 |
| Fax |
|
| Email |
nismaafranisma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Angelin Blessy Y |
| Designation |
Assistant Professor |
| Affiliation |
CHETTINAD ACADEMEY OF RESEARCH AND EDUCATION |
| Address |
OT- Neurology division, Ward No. 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam, Chennai, Tamil Nadu, India
Chennai
TAMIL NADU
603103
India |
| Phone |
7358676117 |
| Fax |
|
| Email |
angelinblessy@care.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nisma B |
| Designation |
UG-student |
| Affiliation |
|
| 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
Chennai
TAMIL NADU
603103
India |
| Phone |
8148213002 |
| Fax |
|
| Email |
nismaafranisma@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 |
NISMA B |
| 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 |
| Dr Angelin Blessy Y |
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
Chennai
TAMIL NADU |
7358676117
angelinblessy@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
|
|
|
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 |
CANADIAN OCCUPATIONAL PERFORMANCE MEASURE (COMP) |
The effort of the intervention will be assessed by comparing the result of pre test collected in the beginning and post test after completing 4 week intervention period |
| Intervention |
TIMER BASED EXECUTIVE FUNCTION TRAINING |
A total of 50 eligible children will be recruited from the Occupational Therapy Department at Chettinad Hospital and Clinics in the Chengalpattu District, and eligibility will be confirmed through appropriate screening procedures. After consent and eligibility confirmation, participants will be randomly assigned to an intervention group (n = 25) and a control group (n = 25). Pre-intervention assessment of independence will be conducted using the Goal Attainment Scale. The experimental group will receive a figurine-based simulation combined with a sensory integration program, with each session lasting approximately 45 minutes, conducted three days per week for a duration of 4 weeks, while the control group will not receive any intervention from the researcher during this period. Following the 4 week intervention, independence will be reassessed using the same tool, and Pre- and post-intervention scores will be statistically Analyzed to evaluate the effectiveness of the intervention. |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 9-15 years with a confirmed diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD), attending a regular school, and able to follow simple verbal instructions.
|
|
| ExclusionCriteria |
| Details |
Children with severe intellectual disability, significant sensory impairments, or diagnoses other than Attention deficit hyperactivity disorder (ADHD) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Canadian Occupational Performance Measure |
Occupational Performance will be assessed using the Canadian Occupational Performance Measure scale.
The intervention and reassessed after four weeks timer based executive function timing |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
19/02/2026 |
| 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 timer based executive function training on occupational performance among children with attention deficit hyperactivity disorder.A total of 50 children aged 9–15 years with a confirmed diagnosis of ADHD will be recruited from the Occupational Therapy Department of Chettinad Hospital and Clinics, Chengalpattu District. Prior to enrollment, informed consent will be obtained from parents or guardians, along with assent from the children, in accordance with approval from the Institutional Review Board of Chettinad University Hospital (CHRI, CARE). Eligible participants will be those attending regular school and able to follow simple verbal instructions. Children with severe intellectual disability, significant sensory impairments, or diagnoses other than ADHD will be excluded. After baseline assessment using the Goal Attainment Scale, participants will be randomly allocated into an intervention group (n=25) or a control group (n=25). The intervention group will receive figurine-based simulation combined with a sensory integration program for 45 minutes per session, three times a week, over 4 weeks, while the control group will receive no intervention during this period. Post-intervention assessment will be conducted using the same outcome measure, and pre- and post-test scores will be statistically analyzed to determine the effectiveness of the intervention. |