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Clinical Trials/NCT03126292
NCT03126292
Active, Not Recruiting
N/A

Promoting Early Child Development in Primary Care for Low-Income Families

University of Illinois at Chicago1 site in 1 country60 target enrollmentOctober 20, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parenting
Sponsor
University of Illinois at Chicago
Enrollment
60
Locations
1
Primary Endpoint
Change in parental knowledge regarding importance of verbal interactions
Status
Active, Not Recruiting
Last Updated
last year

Overview

Brief Summary

The objective of this study is to conduct a 12-month pilot longitudinal study of a parent-directed program delivered in a primary care setting serving primarily low-income families. The parent-direction program will be evaluated in a randomized controlled design to determine the feasibility of protocol implementation and to investigate the potential impact on parental outcomes. Process outcomes will include success with recruitment, participant retention, and ability to collect outcome measures. Clinical outcomes will incorporate measures of parental self-efficacy and parenting behaviors, including observational assessments of parent-child interactions.

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 subsequent school readiness skills 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 program 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.

Registry
clinicaltrials.gov
Start Date
October 20, 2017
End Date
December 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Reshma Shah, MD

Assistant Professor of Pediatrics

University of Illinois at Chicago

Eligibility Criteria

Inclusion Criteria

  • Parent is 18 years or older
  • Child is present for a 2 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

Outcomes

Primary Outcomes

Change in parental knowledge regarding importance of verbal interactions

Time Frame: 6 and 12 months post-enrollment

Change in knowledge regarding importance of talking with children less then 2 years of age as measured by the Thirty Million Word Questionnaire

Participation in cognitively stimulating activities

Time Frame: 12 months post enrollment

Participation in cognitively stimulating activities such as reading and play as measured by the StimQ

Parent-child interactions

Time Frame: 12 months post enrollment

Observational assessment to assess parental sensitivity, involvement in child activities, and engagement in language experiences utilizing the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO)

Study Sites (1)

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