- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03146572
Primary Care and Parenting
February 12, 2020 updated by: Reshma Shah, MD, University of Illinois at Chicago
Utilizing the Primary Care Setting to Deliver a Brief Program to Enhance Parenting Behaviors
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois at Chicago
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 1 year (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Parent of child to receive intervention, 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 Names:
|
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Active Comparator: Control
Parent will receive handout to promote positive behavior
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Handout providing written descriptions of strategies to encourage positive parenting behaviors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Parental Knowledge
Time Frame: Enrollment and 7 months post-enrollment
|
Change in parental knowledge regarding importance of talking with children
|
Enrollment and 7 months post-enrollment
|
|
Change in participation in cognitively stimulating activities
Time Frame: Enrollment and 7 months post-enrollment
|
Change in participation in cognitively stimulating activities such as reading and play as measured by the StimQ
|
Enrollment and 7 months post-enrollment
|
|
Change in parenting self-efficacy
Time Frame: Enrollment and 7 months post-enrollment
|
Change in perceived self-efficacy in parenting activity as measured by The Tool to Measure Parenting Self Efficacy
|
Enrollment and 7 months post-enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Reshma Shah, MD, University of Illinois at Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 3, 2017
Primary Completion (Actual)
February 11, 2018
Study Completion (Actual)
April 6, 2018
Study Registration Dates
First Submitted
May 7, 2017
First Submitted That Met QC Criteria
May 7, 2017
First Posted (Actual)
May 10, 2017
Study Record Updates
Last Update Posted (Actual)
February 13, 2020
Last Update Submitted That Met QC Criteria
February 12, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2014-0337_2
- SDBP (Other Identifier: Society of Developmental and Behavioral Pediatrics)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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