Sit Down and Play India

Development, Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04167254
• Other study ID #: 2014-0337_4
• Status: Completed
• Phase: Phase 1
• Start date: February 7, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2021
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 1, 2021
• Est. primary completion date: August 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Development, Child

Intervention

Behavioral:
• Sit Down and Play
Brief health care-based program that aims to promote key parenting behaviors that promote early childhood development

Locations

Country	Name	City	State
India	Deshnur Primary Health Center	Deshnur	Karnataka
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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