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Child Development and Primary Care in Low Income Families

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03126292
Enrollment
60
Registered
2017-04-24
Start date
2017-10-20
Completion date
2022-12-19
Last updated
2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Development, Child, Parenting

Keywords

Medical home, Primary care, Children, Development

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.

Interventions

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.

OTHERChild Safety Handout

Handout regarding early child safety

Sponsors

University of Illinois at Chicago
Lead SponsorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Months to 3 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in parental knowledge regarding importance of verbal interactions6 and 12 months post-enrollmentChange 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 activities12 months post enrollmentParticipation in cognitively stimulating activities such as reading and play as measured by the StimQ
Parent-child interactions12 months post enrollmentObservational 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)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORReshma Shah, MD

University of Illinois at Chicago

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026