| CTRI Number |
CTRI/2026/01/101842 [Registered on: 22/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [occupational therapy based activity training intervention] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Using Activity Training and Timers to Improve Self-Care, Play, and Daily Activities in Children with Autism spectrum disorder |
|
Scientific Title of Study
|
Effectiveness of activity training combined with timer on selfcare, leisure and productivity among 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 |
Jothika k |
| Designation |
UG student |
| Affiliation |
Chettinad academy of research and education |
| Address |
OT Pediatric Psychiatry Division Ward No 24 Department of Occupational Therapy Chettinad General Hospital Chettinad Health City Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu India 603103
Chennai
TAMIL NADU
603103
India |
| Phone |
9500176938 |
| Fax |
|
| Email |
jothikakittappa325@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhuvaneshwari s |
| Designation |
Assistant professor |
| Affiliation |
Chettinad academy of research and education |
| 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
Chennai
TAMIL NADU
603103
India |
| Phone |
9840016032 |
| Fax |
|
| Email |
bhuvaneshwaris@care.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Jothika k |
| Designation |
UG student |
| Affiliation |
Chettinad academy of research and education |
| Address |
OT Pediatric Psychiatry Division Ward No 24 Department of Occupational Therapy Chettinad General Hospital Chettinad Health City Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu India 603103
Chennai
TAMIL NADU
603103
India |
| Phone |
9500176938 |
| Fax |
|
| Email |
jothikakittappa325@gmail.com |
|
|
Source of Monetary or Material Support
|
| OT Pediatric Psychiatry 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 |
Jothika K |
| Address |
OT Pediatric Psychiatry 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 |
| DrBhuvaneshwaris |
Chettinad general hospital |
OT Pediatric Psychiatry Division Ward No 24 Department of Occupational Therapy Chettinad General Hospital Chettinad Health City Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu India 603103
Chennai
TAMIL NADU |
9840016032
bhuvaneshwaris@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: F840||Autistic disorder, (2) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Canadian occupational performance measure (COPM) |
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 |
occupational therapy based activity training with timer |
Before enrolling each child in the study, informed consent will be obtained from their patients/guardian, along with assessment from the participants, using consent forms approved by the Institutional Review Board of Chettinad University Hospital (CHRI, CARE). A total of 50 individuals, aged 9 to 15 years and diagnosed with Autism spectrum 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 criteria. After obtaining consent and confirming inclusion criteria, participants will be randomly assigned into two groups: an intervention group n = 25 and control group n=25. Pre-intervention assessment of the activity training combined with timer on productivity, leisure and selfcare will be assessed using COPM. The experimental group will receive the Activity training combined with timer while the Control Group will not receive any intervention by researcher during this time. Each session will last 45 minutes, 3 days per week, for 4 weeks. After the 4-weeks of intervention period, the productivity, leisure and selfcare will be reassessed using the same tools COPM. 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 |
Participants who meet DSM-5 criteria
Participants aged between 9 -15 years of age
Children receiving occupational therapy if required
|
|
| ExclusionCriteria |
| Details |
The participants with any other comorbidities were excluded Participants having epilepsy
People having severe musculoskeletal challenges
Participants who are below 9 and above 15 years
|
|
|
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 (COPM) |
The Canadian occupational performance measure (COPM) will be administered at baseline (pre intervention) and immediately after completion of the 4 weeks of 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
|
Phase 2/ Phase 3 |
|
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
|
Before enrolling each
child in the study, informed consent will be obtained from their
patients/guardian, along with assessment from the participants, using consent
forms approved by the Institutional Review Board of Chettinad University
Hospital (CHRI, CARE). A total of 50 individuals, aged 9 to 15 years and
diagnosed with Autism spectrum 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 criteria. After obtaining consent and confirming inclusion
criteria, participants will be randomly assigned into two groups: an
intervention group n = 25 and control
group n=25. Pre-intervention assessment of the
activity training combined with timer on productivity, leisure and
selfcare will be assessed using COPM. The experimental group will receive the
Activity training combined with timer while the Control Group will not receive
any intervention by researcher during this time. Each session will last 45 minutes, 3 days per
week, for 4 weeks. After the 4-weeks of intervention period, the productivity, leisure
and selfcare will be reassessed using the same tools COPM. Pre- and
post-intervention scores will be statistically analyzed to evaluate the
effectiveness of the intervention. |