NCT02871973

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

August 10, 2016

Last Update Submit

February 12, 2020

Conditions

Keywords

parentingchild developmentlanguage

Outcome Measures

Primary Outcomes (2)

  • Caregiver's participation in cognitively stimulating activities such as reading and playing using self-report measure StimQ

    3-4 months post-enrollment

  • Parental Self-Efficacy as measured by Parenting Sense of Competence Scale

    3-4 months post-enrollment

Study Arms (2)

SDP

EXPERIMENTAL

Families randomized to intervention group will receive Sit Down and Play while they wait in the waiting room to be seen by their primary care provider at current and subsequent well-child visit.

Behavioral: Sit Down and Play

CDC Handout

ACTIVE COMPARATOR

Families in the control group will receive the Center for Disease Control and Prevention (CDC) Handout at enrollment.

Behavioral: Handout

Interventions

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.

SDP
HandoutBEHAVIORAL

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

CDC Handout

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Parent is non-English speaking
  • Child is acutely sick

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related 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):e20153393. doi: 10.1542/peds.2015-3393. Epub 2016 Apr 19.

    PMID: 27244800BACKGROUND
  • 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.

    PMID: 26216325BACKGROUND

MeSH Terms

Conditions

Language

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Reshma Shah, MD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Pediatrics

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 18, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2018

Study Completion

September 1, 2018

Last Updated

February 13, 2020

Record last verified: 2020-02

Locations