Exploratory Trial of a Pediatric Web-Based Care Planning Guide (PROSPECT+)

Patient-Reported Outcomes Plus Care Planning Applications for Strengthening Participation on Early Intervention Care Teams

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Developmental Disabilities; Developmental Delay
• Intervention / Treatment: Behavioral: PEM+

Detailed Description

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 further develops and evaluates the Participation and Environment Measure (PEM), an electronic option for family-centered EI service design that has two parts: 1) an evidence-based and promising electronic patient-reported outcome (e-PRO) assessment called the Young Children's Participation and Environment Measure (YC-PEM), and 2) a prototypic goal setting application called Participation and and Environment Measure Plus (PEM+). This project builds on published evidence for its feasibility, acceptability, and preliminary effectiveness of the YC-PEM e-PRO, when paired with a program-specific decision-support tool, on EI service quality. EI stakeholder perspectives on salient supports, barriers, and strategies signal its viability for broader early intervention service system implementation. One important optimization involves expanding its reach to historically minoritized families.

This project will be accomplished in 3 aims: 1. The PEM assessment and intervention content will be culturally adapted to amplify the assessment and consideration of racial climate on young children's participation in activities during the design of an EI service plan (i.e., make content more relevant for racially and ethnically diverse EI families). 2. Artificial intelligence (AI) will be applied to personalize the user experience of the PEM intervention to a broader range of EI enrolled families (i.e., leverage the power of natural language processing as a form of AI, to individualize the PEM intervention to caregivers in two ways). 3. The team will evaluate the effectiveness of the upgraded PEM electronic option to improve caregiver perceptions of family-centered service quality, improve parent engagement in EI service plan implementation, and increase the proportion of participation-focused EI service plans. EI family and provider perspectives will be obtained on supports, barriers, and strategies to its broader implementation in the early intervention service system.

• Study Type: Interventional
• Enrollment (Estimated): 223
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• read, write, and speak English,
• have internet and telephone access
• identify as a parent/legal guardian of a child enrolled in EI for 3+ months

Exclusion Criteria:

• do not read, write, and speak English
• do not have internet and phone access
• do not identify as a parent/legal guardian of a child enrolled in EI for 3+ months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: PEM+	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Rehabilitation Intervention Measure of Engagement - Parent version (PRIME-P)	11-item self-report measure that asks parents what they thought, how they felt, and what they did during their child's therapy session and how the session has affected their overall feelings about the intervention process.	baseline, 4 weeks, 3 months

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: Rocky Mountain Human Services

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: early intervention; environment; participation; families; family-centered care; childhood disability
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Developmental Disabilities
• Other Study ID Numbers: 2020-0908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No