Primary Care and Parenting

Sponsor

University of Illinois at Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT03146572

Collaborator

Society of Developmental and Behavioral Pediatrics (Other)

Enrollment

Location

Arms

12.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Parenting Knowledge, Attitudes, Practice Development, Child	Behavioral: Sit Down and Play Other: Handout	Early Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Utilizing the Primary Care Setting to Deliver a Brief Program to Enhance Parenting Behaviors

Actual Study Start Date :

Apr 3, 2017

Actual Primary Completion Date :

Feb 11, 2018

Actual Study Completion Date :

Apr 6, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Parent of child to receive intervention, Sit Down and Play	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 Names: Handout
Active Comparator: Control Parent will receive handout to promote positive behavior	Other: Handout Handout providing written descriptions of strategies to encourage positive parenting behaviors

Arm

Intervention/Treatment

Experimental: Intervention

Parent of child to receive intervention, Sit Down and Play

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 Names:

Handout

Active Comparator: Control

Parent will receive handout to promote positive behavior

Other: Handout

Handout providing written descriptions of strategies to encourage positive parenting behaviors

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 12 Months

Sexes Eligible for Study:

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:

Parent is non-English speaking Child is acutely sick

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois at Chicago	Chicago	Illinois	United States	60612

Sponsors and Collaborators

University of Illinois at Chicago
Society of Developmental and Behavioral Pediatrics

Investigators

Principal Investigator: Reshma Shah, MD, University of Illinois at Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Reshma Shah, MD, Assistant Professor of Pediatrics, University of Illinois at Chicago

ClinicalTrials.gov Identifier:

NCT03146572

Other Study ID Numbers:

2014-0337_2
SDBP

First Posted:

May 10, 2017

Last Update Posted:

Feb 13, 2020

Last Verified:

Feb 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 13, 2020