Sit Down and Play India

NCT ID: NCT04167254

Last Updated: 2021-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-07

Study Completion Date

2021-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Development, Child

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sit Down and Play

Group Type EXPERIMENTAL

Sit Down and Play

Intervention Type BEHAVIORAL

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

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sit Down and Play

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Reshma Shah, MD

Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reshma Shah

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Deshnur Primary Health Center

Deshnur, Karnataka, India

Site Status

Countries

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United States India

References

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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.

Reference Type DERIVED
PMID: 35508559 (View on PubMed)

Other Identifiers

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2014-0337_4

Identifier Type: -

Identifier Source: org_study_id

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