NCT04326179

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7,720

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

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

Study Start

First participant enrolled

November 4, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2021

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

1.8 years

First QC Date

March 26, 2020

Last Update Submit

April 20, 2023

Conditions

Development, Child

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Screening compliance

    18 months

  • Rate of attending scheduled appointments (show rate)

    18 months

  • Healthcare utilization

    18 months

  • Referral rates

    18 months

Study Arms (1)

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.

Eligibility Criteria

AgeUp to 3 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Duke Children's Primary Care Roxboro Road

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Study Officials

  • Debra Best, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2020

First Posted

March 30, 2020

Study Start

November 4, 2019

Primary Completion

August 6, 2021

Study Completion

August 6, 2021

Last Updated

April 24, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)