NCT04167254

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2020

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

February 7, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

November 14, 2019

Last Update Submit

April 29, 2021

Conditions

Development, Child

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Sit Down and Play

EXPERIMENTAL
Behavioral: Sit Down and Play

Usual Care

NO INTERVENTION

Interventions

Sit Down and PlayBEHAVIORAL

Brief health care-based program that aims to promote key parenting behaviors that promote early childhood development

Sit Down and Play

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Deshnur Primary Health Center

Deshnur, Karnataka, India

Location

Related Publications (1)

  • 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.

    PMID: 35508559DERIVED

Study Officials

  • Reshma Shah

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 18, 2019

Study Start

February 7, 2020

Primary Completion

August 18, 2020

Study Completion

April 1, 2021

Last Updated

May 3, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)US(1)