CClinicalTrials.gg
CompletedNCT03146572Updated Feb 13, 2020

Primary Care and Parenting

An Early Phase 1 interventional study of Sit Down and Play and Handout in Parenting, Knowledge, Attitudes, Practice and Development, Child, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to participants aged 6 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-13.

Sponsored by University of Illinois at Chicago · Early Phase 1, Interventional, and Prevention

Phase
Early Phase 1
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
6 Months to 12 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parenting
  • Knowledge, Attitudes, Practice
  • Development, Child
03

In context

Lead sponsor

University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 12 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

Parent is non-English speaking Child is acutely sick

05

Study design

Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Intervention

    Parent of child to receive intervention, Sit Down and Play

    Behavioral: Sit Down and Play

  • Active comparator
    Control

    Parent will receive handout to promote positive behavior

    Other: Handout

Interventions

  • BehavioralSit 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

    Also known as: Handout

  • OtherHandout

    Handout providing written descriptions of strategies to encourage positive parenting behaviors

06

What researchers measure

Primary outcomes

  1. Change in Parental Knowledge

    Change in parental knowledge regarding importance of talking with children

    Time frame: Enrollment and 7 months post-enrollment

  2. Change in participation in cognitively stimulating activities

    Change in participation in cognitively stimulating activities such as reading and play as measured by the StimQ

    Time frame: Enrollment and 7 months post-enrollment

  3. Change in parenting self-efficacy

    Change in perceived self-efficacy in parenting activity as measured by The Tool to Measure Parenting Self Efficacy

    Time frame: Enrollment and 7 months post-enrollment

07

Study locations

1 site
  • University of Illinois at Chicago
    Chicago, Illinois 60612, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03146572
Lead sponsor
University of Illinois at Chicago
Collaborators
Society of Developmental and Behavioral Pediatrics
Responsible party
Reshma Shah, MD (Assistant Professor of Pediatrics, University of Illinois at Chicago) — Principal investigator
First posted
May 10, 2017
Start date
Apr 3, 2017
Primary completion
Feb 11, 2018
Completion
Apr 6, 2018
Last update
Feb 13, 2020

Study contacts

Reshma Shah, MD
principal investigator · University of Illinois at Chicago

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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