Exploratory Trial of a Pediatric Web-Based Care Planning Guide

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT06458959
Status
Enrolling By Invitation

Conditions

  • Developmental Delay
  • Developmental Disabilities

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • PEM+ — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Jun 14, 2024
Start date
Dec 12, 2024
Status verified
Jul 2026
Primary completion
Aug 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
223 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: PEM+
  • No Intervention: Usual Care

Primary Outcome Measure

Pediatric Rehabilitation Intervention Measure of Engagement - Parent version (PRIME-P) [ Time Frame: baseline, 4 weeks, 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois ChicagoChicagoIllinois60612-

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By research site
University of Illinois Chicago· Chicago, IL

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