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OpenTrials
Completed

NCT Number: NCT03126292

Child Development and Primary Care in Low Income Families

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.

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Key information

Conditions

Parenting Development, Child

Age range

2 month–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sit Down and Play

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.

Child Safety Handout

Other

Handout regarding early child safety

Primary outcomes

  1. 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

  2. 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

  3. 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)

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2022
First posted
Apr 24, 2017
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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