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NCT04562038 · ClinicalTrials.gov registry record · NA

Implementation of Electronic Shared Decision-Making Support for Early Intervention

A NA study, sponsored by University of Illinois at Chicago.

Completed
Registry status
NA
Development phase
76
Enrollment target

NCT04562038: Completed NA study, sponsored by University of Illinois at Chicago.

NCT04562038 is a NA study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 76 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04562038, a NA study, has completed, sponsored by University of Illinois at Chicago.

COMPLETED
Registry status
NA
Development phase
76 participants
Enrollment target

Study Summary

Family-centered care is a best practice approach to delivering high quality early intervention (EI) services for children 0-3 years old with developmental needs. Yet, family engagement in designing and monitoring their child's EI service plan is suboptimal. Families need a valid, reliable, and useful tool to share in decisions about the scope of their child's EI service plan. The investigators will achieve a major advance in contributing occupational therapy expertise to improve family engagement when designing and monitoring their child's EI services. The investigators will test the use of an evidence-based electronic tool with families at one EI program, when the child is due for an annual review of progress in the program. The investigators will also gather input from families, practitioners, and program leadership to identify facilitators and barriers to its use in multiple EI programs. This project tries to test an innovation in how the investigators deliver family-centered and participation-focused care. Study results will yield evidence for the effectiveness of the electronic intervention on parent activation, EI service plan focus, EI service use quantity, parent perceptions of EI service quality, and child functioning.

Primary Outcome

Parent-reported EI quality; 20 items (7-point scale) assesses these domains of family-centered care: 1) enabling and partnership; 2) providing general and specific information; 3) coordinated and comprehensive care; and 4) respectful and supportive care.

Interventions

  • BEHAVIORAL Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO)

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2020-10-01
Est. Completion 2022-06-30
Phase NA
University of Illinois at Chicago

430 total trials

What the finished NCT04562038 record still lists

NCT04562038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO) is the first listed.

NCT04562038 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04562038 about?

NCT04562038 is a clinical study titled "Implementation of Electronic Shared Decision-Making Support for Early Intervention". Family-centered care is a best practice approach to delivering high quality early intervention (EI) services for children 0-3 years old with developmental needs. Yet, family engagement in designing and monitoring their child's EI service plan is suboptimal. Families need a valid, reliable, and usefu...

What is the current status of trial NCT04562038?

This trial is currently completed. It is a NA study. The enrollment target is 76 participants. The study started on 2020-10-01. Estimated completion is 2022-06-30.

What interventions are being tested in trial NCT04562038?

The interventions under investigation include: Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO) (BEHAVIORAL).

Who is sponsoring clinical trial NCT04562038?

This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04562038's enrollment target sits among peer trials

76 1062nd of 2000 higher than 932 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04562038, the US trial registry maintained by the National Library of Medicine. NCT04562038 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.