Clinical trial NCT06458959: Exploratory Trial of a Pediatric Web-Based Care Planning Guide
Official title: Patient-Reported Outcomes Plus Care Planning Applications for Strengthening Participation on Early Intervention Care Teams
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Developmental Disabilities
Developmental Delay
Keywords: early intervention
participation
childhood disability
environment
families
family-centered care
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Rocky Mountain Human Services
First posted: 2024-06-14
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pediatric Rehabilitation Intervention Measure of Engagement - Parent version (PRIME-P)
timeFrame: baseline, 4 weeks, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
Study officials:
References: