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CTRI Number  CTRI/2024/11/076110 [Registered on: 01/11/2024] Trial Registered Prospectively
Last Modified On: 05/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Augmentative and Alternative Communication Intervention]  
Study Design  Other 
Public Title of Study   Development of tool to assess skills and intervention guidelines to improve communication in individuals with severe speech difficulties due to Neurodevelopmental Disorders  
Scientific Title of Study   Development of Multidimensional Augmentative and Alternative Communication Assessment Tool and Related Intervention Guidelines for Individuals with Complex Communication Needs 
Trial Acronym  NIL 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sangeetha G S 
Designation  Part time PhD Scholar 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  9562232768  
Fax    
Email  sangeetha.mchpmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena K D 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  9448824346  
Fax    
Email  r.veena@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Veena K D 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  9448824346  
Fax    
Email  r.veena@manipal.edu  
 
Source of Monetary or Material Support  
Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi District Karnataka 576104 India 
 
Primary Sponsor  
Name  Sangeetha G S 
Address  Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi District Karnataka 576104 India 
Type of Sponsor  Other [Self Sponsored ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Veena K D  Kasturba Hospital   Room No 10 Department of Speech and Hearing, CTC Building 3rd Floor, Kasturba Medical College and Hospital, Madhav Nagar, Manipal, Udupi-576104
Udupi
KARNATAKA 		 9448824346

r.veena@manipal.edu 
Dr Vinitha Mary George  National Institute of Speech and Hearing  Room No G 27, Department of Audiology and Speech Language Pathology, Dhyan Building, National Insitute of Speech and Hearing, Sreekaryam-695017, Trivandrum
Thiruvananthapuram
KERALA 		 7090690938

vinithageorge@nish.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committe e  Approved 
National Institute of Speech and Hearing  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F808||Other developmental disorders of speech and language,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Augmentative and Alternative Communication Intervention   Augmentative and Alternative Communication intervention sessions will be delivered over a period of two months duration. Following the baseline evaluation, short term goals will be selected from the intervention guidelines planner. The intervention aims to improve the communication competency of the participants. Everyday responses to each goal selected will be documented. Following the completion of eight sessions, the performance of the participants in the intervened domains will be reassessed using the assessment tool. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Individuals with Complex Communication Needs who are minimally verbal due to Moderate-Severe degree of Cerebral Palsy/ Global Developmental Delay

Individuals with Complex Communication Needs who are minimally verbal due to Mild- Moderate Autism Spectrum disorder
 
 
ExclusionCriteria 
Details  Individuals with regression, serious illness or health issues and those who need frequent hospitalization 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The assessment tool can be used to identify the skills and strengths in various domains of an individual with Complex Communication Needs to use an Augmentative and Alternative Communication system. The intervention planner can act as a resource for goal setting in Augmentative and Alternative Communication intervention.  Week 1 Baseline assessment prior to intervention session
Week 6 Post intervention assessment
 
 
Secondary Outcome  
Outcome  TimePoints 
Post intervention assessment of communication competency using the developed tool  Week 6 Post intervention assessment  
 
Target Sample Size   Total Sample Size="5"
Sample Size from India="5" 
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 4 
Date of First Enrollment (India)
Modification(s)  		 18/11/2024 
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="3"
Months="0"
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  

Current assessment and intervention research focus on improving the quality of life of individuals irrespective of disorder. The ICF framework for Augmentative and Alternative Communication (AAC) and the Participation model on AAC assessment focus on the environmental participation of the individual rather than a diagnosis. There are not many efforts done based on the ICF framework and participation model in developing AAC assessment tools and intervention guidelines. In India, AAC assessments are focused on administering multiple tests to assess the individuals with Complex Communication Needs (CCN) which is time consuming and not practically possible. Also there is paucity of intervention guidelines framework for rehabilitation professionals to systematically plan intervention of individuals with CCN. Therefore, comprehensive assessment framework as well as related intervention guidelines which are based on ICF and participation model helps rehabilitation professionals to gather information on different domains required for assessment as well as intervention. The current study aims to develop a multidimensional Augmentative and Alternative Communication assessment tool and related intervention guidelines for individuals with complex communication needs.

 
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