Exploratory Trial of a Pediatric Web-Based Care Planning Guide

NCT06458959 | Active Not Recruiting

• 1 other identifier: 2020-0908
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Disabilities; Developmental Delay

Keywords

early intervention; participation; childhood disability; environment; families; family-centered care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

PEM+

EXPERIMENTAL

Behavioral: PEM+

Usual Care

NO INTERVENTION

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.

PEM+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Rocky Mountain Human Services: collaborator

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Developmental Disabilities; Learning Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: cluster randomization at the service coordinator level
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 14, 2024
• Study Start: December 12, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)