Targeting Infant Development With Early Screening

Completed

• Conditions: Development, Child

• Registration Number: NCT04326179
• Lead Sponsor: Duke University

Brief Summary

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

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 Timeline

• Study Start: 2019-11-04
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-30
• Primary Completion: 2021-08-06
• Study Completion: 2021-08-06
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7720

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Screening results	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 Outcome Measures

Name	Time	Method
Screening compliance	18 months	We will use data extracts from the electronic health system to examine screening compliance rate
Healthcare utilization	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.
Rate of attending scheduled appointments (show rate)	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
Referral rates	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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States