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Exploratory Trial of a Pediatric Web-Based Care Planning Guide

NCT06458959 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2024-12-20

No results posted yet for this study

Summary

Infants and toddlers with developmental disabilities or delays use early intervention (EI) for rehabilitation services. Yet, poor quality of EI services is pervasive, particularly for racially and ethnically diverse and socially disadvantaged families. A key lever to improve EI quality is family-centered care, an evidence-based approach that is grounded in family engagement for shared decision-making. This project is motivated by the need to give families a smart and connected option for engaging in the design of the EI service plan for their child. This project upgrades and tests an evidence-based and innovative electronic solution that helps families to organize and share their priorities for change and ideas for goal attainment with professionals, so as to ensure fit of the service plan with their needs.

Conditions

  • Developmental Disabilities
  • Developmental Delay

Interventions

BEHAVIORAL

PEM+

The Young Children's Participation in Environment Measure (YC-PEM), an evidence-based and promising electronic patient-reported outcome (e-PRO) when combined with the Participation and Environment Measure Plus (PEM+) care planning application that yields a summary report and is paired with a program-specific decision-support tool, may support family engaged Early Intervention (EI) service plan development. Intervention group caregivers will complete the YC-PEM e-PRO and PEM+ intervention before their child's annual review of progress. The online summary report will be combined with a program-specific decision-support tool to guide EI service plan development.

Sponsors & Collaborators

  • Rocky Mountain Human Services

    collaborator OTHER

  • University of Illinois at Chicago

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06458959 on ClinicalTrials.gov