Exploratory Trial of a Pediatric Web-Based Care Planning Guide

Developmental Delay Clinical Trial

— PROSPECT+  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458959
• Other study ID #: 2020-0908
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2024
• Source: University of Illinois at Chicago
• Contact: Mary A Khetani
• Phone: 3129960942
• Email: mkhetani[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 223
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Developmental Delay
• Developmental Disabilities

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Rocky Mountain Human Services

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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