Child Development and Primary Care in Low Income Families

Parenting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03126292
• Other study ID #: 2014-0337_3
• Secondary ID: K23HD086295
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 20, 2017
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: July 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Development, Child
• Parenting

Intervention

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.

Other:
• Child Safety Handout
Handout regarding early child safety

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Shah RP, Kunnavakkam R, Msall ME. Pediatricians' knowledge, attitudes, and practice patterns regarding special education and individualized education programs. Acad Pediatr. 2013 Sep-Oct;13(5):430-5. doi: 10.1016/j.acap.2013.03.003. Epub 2013 Mar 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in parental knowledge regarding importance of verbal interactions	Change in knowledge regarding importance of talking with children less then 2 years of age as measured by the Thirty Million Word Questionnaire	6 and 12 months post-enrollment
Primary	Participation in cognitively stimulating activities	Participation in cognitively stimulating activities such as reading and play as measured by the StimQ	12 months post enrollment
Primary	Parent-child interactions	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)	12 months post enrollment