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CTRI Number  CTRI/2024/01/061376 [Registered on: 11/01/2024] Trial Registered Prospectively
Last Modified On: 08/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Reach out and Read Literacy Programme for infants during immunization visits to prevent language delay.  
Scientific Title of Study   Reach Out And Read Literacy Programme on Language Development in Infants A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinuta Deshpande 
Designation  Assistant Professor 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced Physiotherapy center department of pediatric physiotherapy room no.39 Sagar floor Belagavi Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  8754466612  
Fax    
Email  vinuta.gangavatikar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinuta Deshpande 
Designation  Assistant Professor 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced Physiotherapy center department of pediatric physiotherapy room no.39 Sagar floor Belagavi Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  8754466612  
Fax    
Email  vinuta.gangavatikar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Siddhi Kadam 
Designation  PG student  
Affiliation  KLE Institute of Physiotherapy  
Address  Dr Prabhakar Kore Hospital JNMC Campus Nehru Nagar Belgavi

Belgaum
KARNATAKA
590010
India 
Phone  8689990295  
Fax    
Email  siddhik982@gmail.com  
 
Source of Monetary or Material Support  
KLE Dr Prabhakar Kore hospital and research center, Nehru nagar , Belgavi 
 
Primary Sponsor  
Name  KAHER Instiute of physiotherapy 
Address  KAHER institute of physiotherapy, JNMC campus, Nehru Nagar, Belagav 
Type of Sponsor  Research institution and hospital 
 
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 Vinuta Deshpande   KAHER institute of physiotherapy  Advance Physiotherapy center,room no.39,sagar floor,KLE Dr Prabhakar Kore hospital Belgaum Karnataka 590010 India Belgaum KARNATAKA
Belgaum
KARNATAKA 		 8754466612

vinuta.gangavatikar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and ethical committee KAHER institute of physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Infants between the age of 1.5 months to 3.5 months visiting well baby clinic for immunization  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Reach Out And Read Intervention  For the experimental group the intervention is infants will receive age appropriate books in their vernacular language. For 45 mins 3times a day .  
Comparator Agent  Standard Education   The infants will be provided standard education in their vernacular language.  
 
Inclusion Criteria  
Age From  1.50 Month(s)
Age To  3.50 Month(s)
Gender  Both 
Details  Parents willing to participate in the study.
Male and female infants at 6 weeks of age, visiting well baby clinic at tertiary care setup.
Parents willing to get their babies for the first three doses of immunisation (6, 10 and 14 weeks) to the tertiary care hospital in Belagavi.
Infants whose mothers can read and comprehend their vernacular language. 
 
ExclusionCriteria 
Details  Infant who is critically ill.
Infants diagnosed with genetic, congenital or acquired neuromotor, cardiorespiratory, musculoskeletal or metabolic disorders and known cases of developmental delay.
Infants with hearing and vision impairment
Twins and triplets born infants
Infants who have undergone surgery in the past 6 weeks or are referred for any surgery in the next 6 months 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Language Evaluation Scale Trivandrum 0-3 year . Language and speech parameter is assess.  T0 at the age of 1.5 month for 15-20 minutes
T1 at the age of 2.5 month for 15 -20 minutes
T2 at the age of 3.5 month for 15-20 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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 3 
Date of First Enrollment (India)   18/01/2024 
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="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  
•In children Speech and language development is a dynamic process and is one of the most useful pointers for children’s cognitive development, schooling, and academic achievement.
•In developed countries, Parents are most likely to raise speech and language delay (0-6 months) concerns in their encounters with primary care clinicians. In developing countries, parents usually raise concerns during the well-baby visits, when there are no verbalisations by the age of 1 year, if speech is unclear, or if speech or language is different from that of other children of the same age. 
•Speech and language delay concerns are usually raised by the parent, So, parent questionnaires and parent concerns are often used to detect delay.
•A study was conducted in Tamil Nadu, India on children (0-3 years)  attending well-baby clinics, which reported that the prevalence of language delay using the Language Evaluation Scale Trivandrum(LEST) is  20% in infants aged 0–6 months to 59.5% in those aged 7–12 months.
•Most of the studies on language development have been conducted in developed countries and have emphasised the need to target language delay in early years. In India, majorly the studies have examined the prevalence or correlates of language delay in young children. However, there is a paucity of literature on early interventions to enhance infant language development.
•A clinic-based literacy intervention Reach Out and Read (ROR) programmed on preschoolers in India, reported that parents and kids who received the literacy intervention significantly improved their children’s reading behaviour, and proposed that it is crucial to invest in early language programs, to ensure that every child has the opportunity to thrive.
 
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