Sit Down and Play India

Sponsor

University of Illinois at Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT04167254

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

Enrollment

Locations

Arms

13.8

Actual Duration (Months)

29.5

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Development, Child	Behavioral: Sit Down and Play	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 7, 2020

Actual Primary Completion Date :

Aug 18, 2020

Actual Study Completion Date :

Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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
No Intervention: Usual Care

Arm

Intervention/Treatment

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

No Intervention: Usual Care

Outcome Measures

Primary Outcome Measures

Parenting Behaviors that Promote Early Childhood developme [1 month after second immunization visit]
Key items from the UNICEF Multiple Indicator Cluster Surveys Early Childhood Development Module

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois at Chicago	Chicago	Illinois	United States	60612
2	Deshnur Primary Health Center	Deshnur	Karnataka	India

Sponsors and Collaborators

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

Investigators

Principal Investigator: Reshma Shah, University of Illinois at Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Reshma Shah, MD, Assistant Professor of Pediatrics, University of Illinois at Chicago

ClinicalTrials.gov Identifier:

NCT04167254

Other Study ID Numbers:

2014-0337_4

First Posted:

Nov 18, 2019

Last Update Posted:

May 3, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 3, 2021