CTRI

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CTRI Number

CTRI/2025/08/093442 [Registered on: 21/08/2025] Trial Registered Prospectively

Last Modified On:

20/08/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)

Study Design

Other

Public Title of Study

Does a Sit-Down Play intervention Improve Development in Infants Visiting Well Baby Clinics? A Randomized Controlled Trial

Scientific Title of Study

Effect of the Sit Down and Play Intervention on Neurodevelopment in Infant Visiting Well Baby Clinic using Global Scales for Early Development: 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	Shalini Pathak
Designation	post graduate student
Affiliation	KAHER institute of Physiotherpay
Address	Advanced Physiotherapy center department of pediatric physiotherapy room no.39 Sagar floor Belgaum Karnataka 590010 Belgaum KARNATAKA 590010 India Belgaum KARNATAKA 590010 India
Phone	7573068915
Fax
Email	pathakshalini155@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Deepa Metgud
Designation	HOD and professor of the pediatric department
Affiliation	KAHER institute of Physiotherapy
Address	Advanced Physiotherapy center department of pediatric physiotherapy room no.39 Sagar floor Belgaum Karnataka 590010 Belgaum KARNATAKA 590010 India Belgaum KARNATAKA 590010 India
Phone	9845861236
Fax
Email	drdeepa_metgud@yahoo.com

Details of Contact Person
Public Query

Name	Shalini Pathak
Designation	post graduate student
Affiliation	KAHER institute of Physiotherapy
Address	Advanced Physiotherapy center department of pediatric physiotherapy room no.39 Sagar floor Belgaum Karnataka 590010 Belgaum KARNATAKA 590010 India
Phone	7573068915
Fax
Email	pathakshalini155@gmail.com

Source of Monetary or Material Support

KLE Dr Prabhakar Kore Hospital and Research Centre, Nehru Nagar, Belagavi, 590010, Karnataka, India

Primary Sponsor

Name	Shalini Pathak
Address	Advanced Physiotherapy center department of pediatric physiotherapy room no.39 Sagar floor Belgaum Karnataka 590010 Belgaum KARNATAKA 590010 India
Type of Sponsor	Research institution

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
Shalini Pathak	KLE Hospital Well Baby Clinic	Advanced Physiotherapy center department of pediatric physiotherapy room no.39 Sagar floor Belgaum Karnataka 590010 Belgaum KARNATAKA	07573068915 pathakshalini155@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 coming to well baby clinic

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Sit Down and Play intervention	Information will be provided on importance of play along with standard care.
Intervention	Sit Down and Play Intervention	The Sit Down and Play intervention is a short, low-cost program to boost early child development through parent–child play. It is delivered in clinics, where caregivers are shown simple, age-appropriate play activities. Parents sit at the child’s level, talk, and interact using toys. They are encouraged to repeat these activities daily at home. This approach enhances cognitive, language, motor, and social-emotional skills in infants.

Inclusion Criteria

Age From	42.00 Day(s)
Age To	3.00 Month(s)
Gender	Both
Details	Infants 6 weeks who visit the Well Baby clinic, at tertiary care hospital, Belagavi, Infants whose mothers are able to comprehend in vernacular language, Parents who are willing to participate

ExclusionCriteria

Details

Infants who are critically ill,
Infants who are referred for any surgeries,
Infant with genetic disorders, congenital anomalies, metabolic diseases.

Method of Generating Random Sequence

Other

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
The Global Scales for Early Development (GSED)	BASELINE T0- 6TH WEEK OF AGE. T1- 10TH WEEK OF AGE, T3- 14TH WEEK OF AGE

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="36"
Sample Size from India="36"
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)

01/10/2025

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="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

Title:
Effect of the Sit Down and Play Intervention on Neurodevelopment in Infants Visiting Well Baby Clinic using Global Scales for Early Development: A Randomized Controlled Trial

Background & Rationale:
Infancy is a sensitive period for rapid brain growth, influencing motor, cognitive, and socio-emotional development. Early stimulation, particularly through caregiver-infant play, fosters neural connections and developmental skills. Well-baby clinics provide a unique opportunity to integrate structured developmental interventions alongside routine health checks. The Sit Down and Play (SDP) program, involving guided, interactive play with age-appropriate toys, has shown feasibility and acceptability in enhancing parent-child interactions and early developmental outcomes in both international and Indian contexts. However, limited evidence exists on its direct impact within Indian well-baby clinic settings using standardized, globally comparable tools.

Objective:
To evaluate and compare the effect of the SDP intervention on neurodevelopment in infants aged 6–14 weeks attending a well-baby clinic, using the WHO-validated Global Scales for Early Development (GSED).

Methods:
This single-blinded, parallel-group randomized controlled trial will recruit 36 healthy infants (18 per group) at 6 ± 1 weeks of corrected age from a tertiary care well-baby clinic in Belagavi, India. Participants will be randomized via concealed opaque envelopes to an experimental (SDP) or control (standard care) group. The SDP group will receive three structured play sessions at 6, 10, and 14 weeks using age-appropriate toys (rattle, ring, mirror), with caregiver demonstration, supervised practice, and daily home-play encouragement. The control group will receive standard developmental guidance without toys or structured play. Neurodevelopment will be assessed at baseline and at 14 weeks using GSED Short Form (caregiver report) and Long Form (direct assessment) covering motor, language, cognitive, and socio-emotional domains.

Outcome Measures:
Primary outcome – Change in GSED D-score from baseline to 14 weeks.
Secondary outcomes – Parent-reported frequency of play, quality of parent-infant interaction.

Statistical Analysis:
Data will be analyzed using paired and independent t-tests (or non-parametric equivalents), with p<0.05 considered significant.

Expected Impact:
This study will generate evidence on the effectiveness of integrating low-cost, structured play interventions into routine infant care in India. Positive findings could support policy recommendations for embedding SDP into well-baby clinic protocols to promote early childhood development, especially in resource-limited settings.