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CTRI Number  CTRI/2024/10/075858 [Registered on: 24/10/2024] Trial Registered Prospectively
Last Modified On: 20/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparing word production and gestures in children with autism and those with global developmental delay 
Scientific Title of Study   Comparison of vocabulary and gestures between children with autism spectrum disorder and global developmental delay  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arunima OG 
Designation  Post graduate student  
Affiliation  Manipal College of Health Professions Manipal Academy of Higher Education 
Address  Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi 576104 Karnataka India

Udupi
KARNATAKA
576104
India 
Phone  6282683867  
Fax    
Email  arunima.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena KD 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions Manipal Academy of Higher Education 
Address  Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi 576104 Karnataka India

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

Udupi
KARNATAKA
576104
India 
Phone  9448824346  
Fax    
Email  r.veena@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions Manipal Academy of Higher Education Madhav Nagar Manipal Udupi 576104 Karnataka India 
 
Primary Sponsor  
Name  Arunima OG 
Address  Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi 576104 Karnataka India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Veena KD  Kasturba Hospital  Department of Speech and Hearing Speech Therapy section 3rd floor Baliga block Kasturba Hospital Madhav Nagar Manipal Udupi Karnataka 576104
Udupi
KARNATAKA 		 9448824346

r.veena@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC and KH Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F840||Autistic disorder, (2) ICD-10 Condition: F809||Developmental disorder of speech and language, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Children diagnosed with ASD and children diagnosed with global developmental disorder
(Diagnosis based on DSM-V).
Children whose language age in REELS-3 is below 3 years 
 
ExclusionCriteria 
Details  Children with other associated deficits like syndromes cerebral palsy, seizures, Hearing and/or Visual impairment.
Language age in REELS 3 is greater than 3 years  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The tools used in the study provide scores that reflect the early vocabulary and gestures used by children with Autism Spectrum Disorder (ASD) and Global Developmental Delay (GDD). By comparing these scores, we can identify differences and patterns in how each group uses words and gestures.  10 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   31/10/2024 
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="0"
Months="10"
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  
Project Title
Comparison of Vocabulary and Gestures Between Children with Autism Spectrum Disorder and Global Developmental Delay

Type of Study
Prospective Cross-Sectional Study

Aims & Objectives
Primary Objective:
- Identify verbal comprehension, production, and gestures in children diagnosed with Autism Spectrum Disorder (ASD) and Global Developmental Delay (GDD).
- Assess spontaneous speech production of vocabulary and gestures in children with Autism Spectrum Disorder (ASD) and Global Developmental Delay (GDD).

Secondary Objective:
- Analyze speech error patterns in Autism Spectrum Disorder (ASD) and Global Developmental Delay (GDD) groups.

Justification for Study
Current literature often assesses developmental milestones across multiple domains but lacks a focused examination of specific language components in children with ASD and GDD. The few existing studies primarily characterize communication patterns using the Communication Developmental Inventory (CDI) in Western populations. Adaptations of CDI to Indian languages (Kannada and Malayalam) exist, yet research on large and varied populations is limited. 
This study will validate the adapted versions of the MacArthur-Bates Communicative Development Inventories (MCDI) in Kannada and Malayalam, exploring cultural influences on communication development. By profiling vocabulary and gestures, we aim to enhance intervention strategies tailored to the cultural and linguistic context of children with Autism Spectrum Disorder (ASD) and Global Developmental Delay (GDD).

Departments Involved
Department of Speech and Hearing, Therapy section, 3rd floor, Baliga block, Kasturba Hospital 

Study Period
10 months

Sample Size
Sample size calculated using G*power 3.1.9.4 with a target of 39 children per group (Autism Spectrum Disorder  and Global Developmental Delay ) based on expected means and standard deviations. 

7. Materials and Methods
Inclusion Criteria:
- Diagnosis of ASD or GDD based on DSM-V.
- Children with a language age below 3 years on REELS-3.
  
Exclusion Criteria:
- Associated deficits (e.g., cerebral palsy, seizures, visual or hearing impairment).
- Language age above 3 years on REELS-3.

Statistical Methods
- Descriptive Statistics: Mean and SD for normally distributed data; median and IQR for non-normally distributed data.
- Inferential Statistics: t-test or Mann-Whitney U test for group comparisons; significance set at p < 0.05.

Tools Used
1. Adapted MCDI (Kannada and Malayalam)- Measures early speech and gestures (Dr. Veena KD / Dr. Sunila John, 2014).
2. Receptive Expressive Emergent Language Test, Third Edition- Measures receptive and expressive language (Bzoch, League, and Brown, 2003).
3. Com DEALL - Assesses various developmental skills (Prathibha Karanth, 2011).

Procedure:
1. Obtain clearance from Institutional Review Committee (IRC) and Ethics Committee (IEC).
2. Identify and recruit participants meeting the inclusion criteria from the Department of Speech and Hearing.
3. Obtain informed consent from parents.
4. Administer the adapted MCDI and conduct play sessions to elicit spontaneous speech from children.
5. A picture will be selected for the vocabulary and gestures and will be presented to the child during the play session. The child will be asked to name the picture to elicit spontaneous productions. 
6.The spontaneous productions will be audio-recorded and stored  for later analysis. 
7.Com DEALL , a developmental checklist would also be administered as a part of routine evaluation to evaluate the gross motor, fine motor skills, activities of daily living, receptive language, expressive language, cognitive skills, social skills and emotional skills.


Outcome Measures
The study obtains scores from both the scale and the checklist. This provides the measure of early vocabulary and gestures present in children with Autism Spectrum Disorder  and Global Developmental Delay. This will help us in comparing the patterns of vocabulary and gestures between both the groups.

Potential Risks and Benefits
Risks: Minimal discomfort or anxiety from completing questionnaires; mitigated by allowing sufficient time.
Benefits: Contributing to understanding specific vocabulary patterns, aiding in individualized therapy plans for children with Autism Spectrum Disorder  and Global Developmental Delay.

Ethical Considerations
Approval from IEC and CTRI registration prior to participant recruitment.

Budget
N/A

Review of Literature
Studies highlight significant differences in language and communication development between children with Autism Spectrum Disorder  and Global Developmental Delay. For instance:
- Luyster et al. (2007) noted delays in vocabulary and nonverbal communication in children with Autism Spectrum Disorder .
- Lee et al. (2018) emphasized social engagement differences, with children with Global Developmental Delay showing more emotional engagement than those with Autism Spectrum Disorder .
- Taddei et al. (2023) reported delays in communication and social-emotional skills for both groups, with distinct profiles emerging.
- Wang et al. (2021) identified developmental imbalances in language and reasoning, indicating different areas of delay for Autism Spectrum Disorder  and Global Developmental Delay children.

These studies underscore the necessity for in-depth investigations of language components to inform targeted interventions for diverse populations. 
This structured approach is aimed at addressing the gap in understanding and enhancing the clinical practice related to language development in children with Autism Spectrum Disorder  and Global Developmental Delay.
 
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