NCT03126292

Brief Summary

The objective of this study is to conduct a 12-month pilot longitudinal study of a parent-directed program delivered in a primary care setting serving primarily low-income families. The parent-direction program will be evaluated in a randomized controlled design to determine the feasibility of protocol implementation and to investigate the potential impact on parental outcomes. Process outcomes will include success with recruitment, participant retention, and ability to collect outcome measures. Clinical outcomes will incorporate measures of parental self-efficacy and parenting behaviors, including observational assessments of parent-child interactions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 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

First Submitted

Initial submission to the registry

April 18, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

October 20, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2019

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2022

Completed
Last Updated

March 25, 2026

Status Verified

January 1, 2025

Enrollment Period

1.7 years

First QC Date

April 18, 2017

Last Update Submit

March 20, 2026

Conditions

ParentingDevelopment, Child

Keywords

Medical homePrimary careChildrenDevelopment

Outcome Measures

Primary Outcomes (3)

  • Change in parental knowledge regarding importance of verbal interactions

    Change in knowledge regarding importance of talking with children less then 2 years of age as measured by the Thirty Million Word Questionnaire

    6 and 12 months post-enrollment

  • Participation in cognitively stimulating activities

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

    12 months post enrollment

  • Parent-child interactions

    Observational assessment to assess parental sensitivity, involvement in child activities, and engagement in language experiences utilizing the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO)

    12 months post enrollment

Study Arms (2)

Sit Down and Play

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 visits.

Behavioral: Sit Down and Play

Handout

ACTIVE COMPARATOR

Families in the control group will receive handouts regarding child safety

Other: Child Safety Handout

Interventions

Sit Down and PlayBEHAVIORAL

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.

Sit Down and Play
Child Safety HandoutOTHER

Handout regarding early child safety

Handout

Eligibility Criteria

Age2 Months - 3 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parent is 18 years or older
  • Child is present for a 2 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 RP, Kunnavakkam R, Msall ME. Pediatricians' knowledge, attitudes, and practice patterns regarding special education and individualized education programs. Acad Pediatr. 2013 Sep-Oct;13(5):430-5. doi: 10.1016/j.acap.2013.03.003. Epub 2013 Mar 14.

    PMID: 23707687BACKGROUND

Study Officials

  • Reshma Shah, MD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 18, 2017

First Posted

April 24, 2017

Study Start

October 20, 2017

Primary Completion

July 5, 2019

Study Completion

December 19, 2022

Last Updated

March 25, 2026

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)