N/A
N=28
Participation and Environment Measure-Plus (PEM-Plus) Care Planning Intervention
Developmental Disability · Early Intervention (Education)
Bottom Line
View on ClinicalTrials.gov: NCT03820011 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Mean Retention Rates — 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PEM+ (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mary A Khetani
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Retention Rates |
18 | — |
| PRIMARY Median PEM+ Completion Time |
13.6; 12.99 | — |
| PRIMARY Percentage of Caregivers Completing PEM+ Independently |
17 | — |
| PRIMARY Median Number of PEM+ Care Plans Created |
2.5 | — |
| PRIMARY Usefulness, Satisfaction, and Ease of Use Questionnaire (USE) |
4.41; NA; 4.64; 4.4; 4.97; 5.4 | — |
| PRIMARY Caregiver Self-Efficacy to Promote Child's Participation in Activities |
4.61; 4.72 | — |
Summary
The goal of the proposed research is to achieve a major advance in promoting effective and efficient delivery of pediatric rehabilitation services for young children with developmental disabilities and delays. The investigative team will examine the usability, feasibility, acceptability, and preliminary effects of PEM+, an innovative web-based (mobile friendly) guide for care planning by parents of young children with developmental disabilities and delays. PEM+ is designed in partnership with parents and providers to support more collaborative and efficient clinical care planning with individual families who typically access pediatric occupational therapy services. Specifically, PEM+ enables parents to build on their baseline assessment of their child using the Young Children's Participation and Environment Measure (YC-PEM) to design specific solutions to their young child's participation-related problems. PEM+ affords parents the opportunity to do this in their own space and on their own schedule, as well as electronically share their proposed written solutions with their child's provider(s) and/or other important individuals in their young child's life.
Eligibility Criteria
Aim 1 Inclusion Criteria:
- at least 18 years old
- reads, writes, and speaks English
- has access to broadband internet
- resides in the U.S
- has a child between 0 and 3 years old who is receiving services for developmental delay.
Aim 1 Exclusion Criteria:
- has a child over 3 years old
- does not have internet access
- has a child who is not receiving rehabilitation services for developmental delay
- does not reside in the U.S.
Aim 2 Inclusion Criteria:
- 18 years or older
- reads, writes, and speaks in English
- has a child aged 0-5 years old who was receiving rehabilitation services
- has broadband internet access
- denotes at least one area of desired change during participation assessment.
Aim 2 Exclusion Criteria:
- has a child over 5 years old
- does not have internet access
- has a child who is not receiving rehabilitation services for developmental delay
- does not reside in the U.S.
Data sourced from ClinicalTrials.gov (NCT03820011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.