Primary Care-based Program to Enhance Positive Parenting Practices

NCT ID: NCT02871973

Last Updated: 2020-02-13

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

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-09-30

Brief Summary

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The objective of this research is to conduct a small randomized pilot study to evaluate the feasibility of Sit Down and Play (SDP), a brief, low-cost program delivered in the primary care setting to enhance parent-child interactions and explore potential impacts on parenting behaviors.

Detailed Description

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Enriching parenting behaviors in early childhood promotes child development and offers a promising strategy to reduce future educational disparities. However, current interventions are limited by cost and have not been widely disseminated. Recognized as a target for research to improve early childhood development and school readiness among at-risk families, the primary care setting offers an ideal opportunity to reach the millions of children living in poverty.However, what remains unknown is how to more efficiently leverage the primary care setting to deliver a sustainable and effective preventive intervention to promote positive parenting behaviors and encourage early childhood development in low-income families. Therefore, the investigators designed Sit Down and Play (SDP) a brief parent-directed program delivered in the primary care setting. Modeled after the widely disseminated literacy program Reach Out and Read and grounded in social cognitive theory, SDP is intended to take place during each pediatric well-child visit occurring in a child's first two years with the goal of promoting positive parenting behaviors.

Conditions

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Parenting Development Language Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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SDP

Families randomized to intervention group will receive Sit Down and Play while they wait in the waiting room to be seen by their primary care provider at current and subsequent well-child visit.

Group Type EXPERIMENTAL

Sit Down and Play

Intervention Type BEHAVIORAL

Sit Down and Play (SDP) is designed to be a brief, low-cost intervention that incorporates key theoretical constructs to elicit positive parenting behaviors. It is intended to be delivered by existing clinical staff, nonprofessionals, or volunteers during each of the eight well-child visits between 2-24 months of age while a family waits to be seen by their pediatrician in the examination room.

CDC Handout

Families in the control group will receive the Center for Disease Control and Prevention (CDC) Handout at enrollment.

Group Type ACTIVE_COMPARATOR

Handout

Intervention Type BEHAVIORAL

Handouts developed by Center for Disease Control and Prevention (CDC) to provide information regarding age-specific early childhood milestones

Interventions

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Sit Down and Play

Sit Down and Play (SDP) is designed to be a brief, low-cost intervention that incorporates key theoretical constructs to elicit positive parenting behaviors. It is intended to be delivered by existing clinical staff, nonprofessionals, or volunteers during each of the eight well-child visits between 2-24 months of age while a family waits to be seen by their pediatrician in the examination room.

Intervention Type BEHAVIORAL

Handout

Handouts developed by Center for Disease Control and Prevention (CDC) to provide information regarding age-specific early childhood milestones

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Parent is 18 years or older
* Child is present for a 2, 4, or 6 month well-child visit
* Adult present with child at appointment is parent/caregiver of child

Exclusion Criteria

* Parent is non-English speaking
* Child is acutely sick
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Reshma Shah, MD

Assistant Professor of Clinical Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reshma Shah, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Shah R, Kennedy S, Clark MD, Bauer SC, Schwartz A. Primary Care-Based Interventions to Promote Positive Parenting Behaviors: A Meta-analysis. Pediatrics. 2016 May;137(5):e20153393. doi: 10.1542/peds.2015-3393. Epub 2016 Apr 19.

Reference Type BACKGROUND
PMID: 27244800 (View on PubMed)

Shah R, Sobotka SA, Chen YF, Msall ME. Positive Parenting Practices, Health Disparities, and Developmental Progress. Pediatrics. 2015 Aug;136(2):318-26. doi: 10.1542/peds.2014-3390.

Reference Type BACKGROUND
PMID: 26216325 (View on PubMed)

Other Identifiers

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UL1TR000050

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2014-0337_1

Identifier Type: -

Identifier Source: org_study_id

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