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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02871973
Other study ID # 2014-0337_1
Secondary ID UL1TR000050
Status Completed
Phase N/A
First received
Last updated
Start date July 2016
Est. completion date September 2018

Study information

Verified date February 2020
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 2018
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


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.
Handout
Handouts developed by Center for Disease Control and Prevention (CDC) to provide information regarding age-specific early childhood milestones

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Chicago

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). pii: e20153393. doi: 10.1542/peds.2015-3393. Epub 2016 Apr 19. Review. — View Citation

Shah R, Sobotka SA, Chen YF, Msall ME. Positive Parenting Practices, Health Disparities, and Developmental Progress. Pediatrics. 2015 Aug;136(2):318-26. doi: 10.1542/peds.2014-3390. — View Citation

Outcome

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