Targeting Infant Development With Early Screening

NCT ID: NCT04326179

Last Updated: 2023-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7720 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-04

Study Completion Date

2021-08-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Development, Child

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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
Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Debra Best, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00103604

Identifier Type: -

Identifier Source: org_study_id

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