An interventional study of PEM+ in Developmental Disabilities and Developmental Delay, sponsored by University of Illinois at Chicago. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Supportive care
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.
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.
230 studies on the registry are indexed under Developmental Disabilities; 65 are open to participants now.
This study's planned enrollment of 223 is above the median of 60 across 150 interventional studies indexed under Developmental Disabilities.
Browse Developmental Disabilities studies →University of Illinois at Chicago is the lead sponsor of 506 studies on the registry; 120 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
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Exclusion Criteria:
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.
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.
Time frame: baseline, 4 weeks, 3 months
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Nov 2026, 23 months after the start.
Of 96 non-industry interventional studies with no phase under Developmental Disabilities, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 49. This study's planned 23 months is close to that.
Counting every sponsor, half of 97 studies reached it within 22 months; a quarter within 13 and three quarters within 49.
Primary completion moved once since we started tracking on Sep 25, 2026: Aug 2026 → Nov 2026, on Oct 5, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Illinois at Chicago →