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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03146572
Other study ID # 2014-0337_2
Secondary ID SDBP
Status Completed
Phase Early Phase 1
First received
Last updated
Start date April 3, 2017
Est. completion date April 6, 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 study to evaluate potential impact of a brief, low-cost primary care-based intervention of parenting self-efficacy, knowledge, and behavior.


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 Completed
Enrollment 61
Est. completion date April 6, 2018
Est. primary completion date February 11, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 12 Months
Eligibility Inclusion Criteria:

Parent is 18 years or older Child is present for a 6, 9, or 12 month well-child visit who attends University of Illinois at Chicago (UIC) for well-child care Adult present with child at appointment is parent/caregiver of child

Exclusion Criteria:

Parent is non-English speaking Child is acutely sick

Study Design


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:
Handout
Handout providing written descriptions of strategies to encourage positive parenting behaviors

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University of Illinois at Chicago Society of Developmental and Behavioral Pediatrics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Parental Knowledge Change in parental knowledge regarding importance of talking with children Enrollment and 7 months post-enrollment
Primary Change in participation in cognitively stimulating activities Change in participation in cognitively stimulating activities such as reading and play as measured by the StimQ Enrollment and 7 months post-enrollment
Primary Change in parenting self-efficacy Change in perceived self-efficacy in parenting activity as measured by The Tool to Measure Parenting Self Efficacy Enrollment and 7 months post-enrollment
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