Primary Care-based Program to Enhance Positive Parenting Practices

February 12, 2020 updated by: Reshma Shah, MD, University of Illinois at Chicago

Sit Down and Play: A Primary Care-Based Program to Promote Positive Parenting Practices

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Active Comparator: CDC Handout
Families in the control group will receive the Center for Disease Control and Prevention (CDC) Handout at enrollment.
Behavioral: Handout
Handouts developed by Center for Disease Control and Prevention (CDC) to provide information regarding age-specific early childhood milestones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Caregiver's participation in cognitively stimulating activities such as reading and playing using self-report measure StimQ
Time Frame: 3-4 months post-enrollment
3-4 months post-enrollment
Parental Self-Efficacy as measured by Parenting Sense of Competence Scale
Time Frame: 3-4 months post-enrollment
3-4 months post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Investigators

  • Principal Investigator: Reshma Shah, MD, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 18, 2016

Study Record Updates

Last Update Posted (Actual)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-0337_1
  • UL1TR000050 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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