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OpenTrials
Completed

NCT Number: NCT04326179

Targeting Infant Development With Early Screening

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.

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Key information

Conditions

Development, Child

Age range

Up to 3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Screening results

    Time frame: 18 months

    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.

Secondary outcomes

  1. Screening compliance

    Time frame: 18 months

    We will use data extracts from the electronic health system to examine screening compliance rate

  2. Rate of attending scheduled appointments (show rate)

    Time frame: 18 months

    We will use data extracts from the electronic health system to examine rate of families attending their scheduled appointments and no-show rate

  3. Healthcare utilization

    Time frame: 18 months

    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.

  4. Referral rates

    Time frame: 18 months

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: TIDES

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 30, 2020
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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