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CTRI Number  CTRI/2025/12/099202 [Registered on: 16/12/2025] Trial Registered Prospectively
Last Modified On: 15/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [occupational therapy]  
Study Design  Other 
Public Title of Study   How Occupational Therapy Helps learning disability Children to Improve Their Social Participation and interaction with their aged children  
Scientific Title of Study   effect of occupational therapy intervention in enhancing social problem solving skills in children with learning disabilities(lD)- pilot study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karuna Nadkarni 
Designation  In-Charge and Associate Professor 
Affiliation  Occupational Therapy School and Centre, Seth G.S. Medical College and K.E.M. Hospital  
Address  Occupational Therapy School And Centre Seth G. S. Medical College and K. E. M. Hospital Parel Mumbai 400012 I C 408 Dreams CHS Bhandup West Mumbai 400078 Maharashtra

Mumbai
MAHARASHTRA
400012
India 
Phone  7738922552  
Fax    
Email  Karunanadkarni@kem.edu  
 
Details of Contact Person
Scientific Query  
Name  Chaitanya Dhakanepatil  
Designation  PG student 
Affiliation  Occupational Therapy School and Centre, Seth G.S. Medical College and K.E.M. Hospital  
Address  Occupational Therapy School And Centre Seth G. S. Medical College and K. E. M. Hospital Parel Mumbai 400012 I C 408 Dreams CHS Bhandup West Mumbai 400078 Maharashtra

Mumbai
MAHARASHTRA
400012
India 
Phone  9273324969  
Fax    
Email  chaitanyadhakane1999@gmail.com  
 
Details of Contact Person
Public Query  
Name  Karuna Nadkarni 
Designation  In-Charge and Associate Professor 
Affiliation  Occupational Therapy School and Centre, Seth G.S. Medical College and K.E.M. Hospital  
Address  Occupational Therapy School And Centre Seth G. S. Medical College and K. E. M. Hospital Parel Mumbai 400012 I C 408 Dreams CHS Bhandup West Mumbai 400078 Maharashtra

Mumbai
MAHARASHTRA
400012
India 
Phone  7738922552  
Fax    
Email  Karunanadkarni@kem.edu  
 
Source of Monetary or Material Support  
Occupational therapy school and centre and kem hospital mumbai 
 
Primary Sponsor  
Name  Chaitanya Dhakanepatil  
Address  Parel mumbai 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Karuna Nadkarni  occupational Therapy school and centre and KEM Hospital   Occupational Therapy School and Centre Seth G S Medical College and K E M Hospital Parel Mumbai 400012
Mumbai
MAHARASHTRA 		 07738922552

Karunanadkarni@kem.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSITUTIONAL ETHICS COMMITTEE II RELATING TO BIOMEDICAL AND HEALTH RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F79||Unspecified intellectual disabilities,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Assessment of communication and interaction skills  pre and post scores of ACIS is used as comparator 
Intervention  Occupational Therapy Intervention in Enhancing Social Problem-Solving Skills in Children with Learning Disability (LD)   Phase 1: Building Awareness (Weeks 1-3) - Emotion recognition, eye contact, turn-taking. Phase 2: Developing Social Skills (Weeks 4-6) - Conversational skills, listening, expressing needs. Phase 3: Problem-Solving & Friendship (Weeks 7-9) - Conflict resolution, cooperative play, personal boundaries. Phase 4: Generalization (Weeks 10-12) - Real-life practice, peer interactions, final assessments. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  LD (dyslexia, dysgraphia, dyscalculia) and normal
intellectual functioning. 
 
ExclusionCriteria 
Details  Comorbidities like cerebral palsy, epilepsy, autism, or hyperactivity (ruled out using the Vanderbilt ADHD Diagnostic Rating Scale). 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improved eye contact, turn-taking, and active listening.
- Increased confidence in social settings.
 		 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Enhanced peer relationships and reduced social anxiety.  12 week 
 
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)   31/12/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [karunanadkarni@kem.edu].

  6. For how long will this data be available start date provided 05-02-2027 and end date provided 05-02-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Summary of the Study Protocol 
Title: 
Effect of Occupational Therapy Intervention in Enhancing Social Problem-Solving Skills in 
Children with Learning Disability LD– Pilot Study. 
Introduction: 
Learning disabilities (LD) are neurodevelopmental disorders affecting academic skills like 
reading, writing, and math, despite normal intelligence. They also impact social problem-solving 
due to deficits in executive functions like memory cognitive flexibility and inhibitory control. 
This can lead to social isolation low self-esteem and academic struggles. 
Occupational therapy (OT) can help by improving sensory processing fine motor skills
executive functioning, and psychosocial adaptation through structured interventions. 
Aim: 
To evaluate the effectiveness of OT interventions in enhancing social problem-solving skills in 
children with LD. 
Objectives: 
1 Assess social problem-solving skills. 
2 Implement OT interventions. 
3 Identify effective strategies. 
4 Explore perceived benefits. 
5 Provide evidence-based recommendations. 
Rationale: 
Children with LD struggle with social problem-solving, leading to emotional and social 
difficulties. This study aims to demonstrate how OT interventions using social stories role
playing and conflict resolution techniques can improve these skills fostering better social 
competence and self-esteem. 
Review of Literature: 
- Studies reviewed highlight the impact of LD on social skills the effectiveness of sensory 
integration therapy and evidence-based assessment methods for LD. Sensory Integration Therapy (SIT) improves sensory processing and task participation while 
OT interventions enhance social competence in children with dyspraxia. 
Study Design: - Pilot Study with 30 participants - Conducted at KEM Hospital Mumbai Inclusion Criteria: Children 6-12 years with LD dyslexia, dysgraphia dyscalculia and normal 
intellectual functioning. 
- Exclusion Criteria: Comorbidities like cerebral palsy epilepsy autism or hyperactivity ruled 
out using the Vanderbilt ADHD Diagnostic Rating Scale. 
Methodology: 
- Pre-Post Intervention Design: Participants undergo 12 weeks of OT sessions. 
- Assessment Tools: 
 -ACIS Assessment of Communication and Interaction Skills to measure psychosocial learning 
aspects. 
 - Observational checklists parent or teacher reports and academic performance tests. 
-Data Analysis: Wilcoxon Signed Rank Test will compare pre- and post-intervention scores. 
Statistical significance: p less than 0.05. 
Intervention Protocol 12 Weeks: 
Phase 1: Building Awareness Weeks 1-3
 - Emotion recognition eye contact turn-taking. 
Phase 2: Developing Social Skills Weeks 4-6
 Conversational skills listening expressing needs. 
Phase 3: Problem-Solving & Friendship Weeks 7-9
 Conflict resolution cooperative play personal boundaries. 
Phase 4: Generalization Weeks 10-12
 - Real-life practice peer interactions final assessments. 
Expected Outcomes: 
Improved eye contact turn-taking and active listening. 
Increased confidence in social settings. 
Enhanced peer relationships and reduced social anxiety. 
Conclusion: 
This study aims to provide evidence for the role of OT in fostering essential social problem solving skills in children with LD.
 
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