Targeting Infant Development With Early Screening (TIDES)

The purpose of this study is to assess feasibility and acceptability of parent-completed screeners of child social/emotional development, social determinants of health, and adverse childhood experiences in the setting of a pediatrics primary care clinic.

Study Overview

• Status: Completed
• Conditions: Development, Child

Detailed Description

Local pediatric primary care practices are beginning to implement universal screening. The investigators plan to assess feasibility and acceptability of screening by querying parents of children in order to determine their expectations, perceptions, and opinions about the screeners. The investigators will also use data from electronic health records to examine the impact of screeners on referrals and healthcare utilization. The investigators will be examining screening rates and outcomes, and correlations with demographics and changes over time.

• Study Type: Observational
• Enrollment (Actual): 7720

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Duke Children's Primary Care Roxboro Road

Description

Inclusion for general practice retrospective reviews:

• Seen for a well child check at Duke Children's Primary Care Roxboro Road.
• Age 0 to 4 at day of visit

Inclusion for targeted retro reviews:

• Seen for well check at Duke Children's Primary Care Roxboro Road
• Determined by HealthySteps to require Tier 2 or Tier 3 behavioral support services
• Age 0 to 4 at day of visit

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Age 0 to 4 at day of visit; This study is based on chart reviews of data collected as part of clinical care. Data collected as part of this study will not directly inform the care of participating patients and families.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening results	We will use data extracts from the electronic health system to examine rates of meeting positive/negative thresholds on screening tools used as part of clinical care.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening compliance	We will use data extracts from the electronic health system to examine screening compliance rate	18 months
Rate of attending scheduled appointments (show rate)	We will use data extracts from the electronic health system to examine rate of families attending their scheduled appointments and no-show rate	18 months
Healthcare utilization	Data extracts from Epic and/or from DEDUCE will be used to evaluate healthcare utilization. For the targeted chart review, we will look specifically at families who are enrolled in or who qualify for Healthy Steps Tier 2 and Tier 3, subsets of the whole practice who are receiving additional co-located behavioral supports during standard well child care.	18 months
Referral rates	Data extracts from Epic and/or from DEDUCE will be used to evaluate rates of referrals to other services. For the targeted chart review, we will look specifically at families who are enrolled in or who qualify for Healthy Steps Tier 2 and Tier 3, subsets of the whole practice who are receiving additional co-located behavioral supports during standard well child care.	18 months

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Debra Best, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Actual): August 6, 2021
• Study Completion (Actual): August 6, 2021

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Pro00103604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No