Sit Down and Play India

Feasibility of Implementing Sit Down and Play in Routine Visits in India

To gather data essential to evaluate the acceptability and feasibility of a brief, health care-based program delivered in routine healthcare visits in low and low-middle income countries to promote positive parenting behaviors with the aim to support early child development.

Study Overview

• Status: Completed
• Conditions: Development, Child
• Intervention / Treatment: Behavioral: Sit Down and Play

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Deshnur, Karnataka, India
      • Deshnur Primary Health Center
• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Parents/legal guardians will be eligible if they:

• Are over the age of 18 years
• Have a child between 6 and 10 weeks
• Are presenting to Deshnur and Murgod Primary Health Centers in Karnataka, India for a heatlh visit and
• Self-identify as the "primary caregiver.

Exclusion Criteria:

Parents/legal guardians will be ineligible if they:

• Are less than the age of 18 years
• Have a child who is not between 6 and 10 weeks or
• Have a child who is sick at the time of visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: Sit Down and Play	Behavioral: Sit Down and Play; Brief health care-based program that aims to promote key parenting behaviors that promote early childhood development

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting Behaviors that Promote Early Childhood developme	Key items from the UNICEF Multiple Indicator Cluster Surveys Early Childhood Development Module	1 month after second immunization visit

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Reshma Shah, University of Illinois at Chicago

Publications and helpful links

General Publications

• Shah R, Herekar V, Metgud D, Kim H, Atkins M, Dhaded S. Implementing an early childhood development intervention with routine immunization visits in India: a feasibility trial. Eur J Pediatr. 2022 Jul;181(7):2799-2808. doi: 10.1007/s00431-022-04485-w. Epub 2022 May 5.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2020
• Primary Completion (Actual): August 18, 2020
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2014-0337_4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No