| CTRI Number |
CTRI/2025/07/090001 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational therapist ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Evaluate the Effect of Free-Time Based Group Therapy on Thinking and Planning Abilities in Children with Specific Learning Disabilities. |
|
Scientific Title of Study
|
Effectiveness of Group Therapy Focused on Leisure Based Executive Functional Skills Training on Executive Functions among children with Specific Learning Disability. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Veda Varshini T |
| Designation |
PG Student |
| Affiliation |
Chettinad School of Occupational Therapy Kelambakkam |
| Address |
OT-Pediatric Division, Ward No: 24, Department of Occupational Therapy,
Chettinad General Hospital,
Chettinad Health City,
Rajiv Gandhi Salai Kelambakkam.
Chennai
TAMIL NADU
603103
India |
| Phone |
9360877085 |
| Fax |
|
| Email |
tvedavarshini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Bhuvaneshwari S |
| Designation |
Assistant Professor |
| Affiliation |
Chettinad School of Occupational Therapy Kelambakkam |
| Address |
OT-Pediatric Division, Ward No: 24, Department of Occupational Therapy,
Chettinad General Hospital,
Chettinad Health City,
Rajiv Gandhi Salai Kelambakkam.
Chennai
TAMIL NADU
603103
India |
| Phone |
9840016032 |
| Fax |
|
| Email |
bhuvaneshwaris@care.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Veda Varshini T |
| Designation |
PG Student |
| Affiliation |
Chettinad School of Occupational Therapy Kelambakkam |
| Address |
OT-Pediatric Division, Ward No. 24, Department of Occupational Therapy,
Chettinad General Hospital,
Chettinad Health City,
Rajiv Gandhi Salai Kelambakkam.
Chennai
TAMIL NADU
603103
India |
| Phone |
9360877085 |
| Fax |
|
| Email |
tvedavarshini@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 Kelambakkam.
TN 603103
India |
|
|
Primary Sponsor
|
| Name |
Veda Varshini T |
| Address |
Chettinad Health City
Rajiv Gandhi Salai OMR
Kelambakkam TN 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 Bhuvaneshwari S |
Chettinad General Hospital |
OT-Pediatric Division, Ward No: 24, Department of Occupational Therapy,
Chettinad General Hospital,
Chettinad Health City,
Rajiv Gandhi Salai Kelambakkam.
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: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Executive Skills Questionnaire |
The effect of the intervention will be assessed by comparing the results of the pre-test collected in the begining and post-test after completing the 8-week intervention period. |
| Intervention |
Group Therapy |
Subjects will participate in group therapy for 8 weeks. Intervention will focus on improving executive functions through leisure activities. Each session will last 45 minutes and will be held once a week. There will be a total of 8 sessions. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Participants aged between 10-14 years of age
Participants who meet the DSM-5 Criteria for mild- moderate level Specific Learning Disorder
Participants having IQ Range greater than 69
Participants able to read, write and understand English
|
|
| ExclusionCriteria |
| Details |
The participants with any other comorbidities were excluded
Participants having epilepsy
Participants having severe musculoskeletal challenges
Participants who are below 10 years and above 14 years |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Executive Skills Questionnaire (ESQ)
Childrens Leisure Assessment scale (CLASS) |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/09/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 Group therapy focused on Leisure Based Executive Functional Skills training in children with Specific Learning Disorders. The intervention will be conducted over Eight weeks at Chettinad Health City Hospital in India. The primary outcome measures are the Executive Skills Questionnaire and the Children’s Leisure Assessment Scale, both of which were assessed over a two-month period.
|