- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07505121
Comparing the Impact of Peer Support vs. Staff-Delivered Transportation Interventions for Young Adults With Intellectual and Developmental Disabilities. (YA-IDD)
Comparing Peer Support and Staff-Delivered Transportation Interventions for Young Adults With Intellectual and Developmental Disabilities (YA-IDD) on Loneliness, Social Participation, and Transportation Skills
This clinical trial will look at whether young adults with intellectual and developmental disabilities (YA-IDD) have better outcomes when a travel training intervention called Ready to Ride (R2R) is taught by a specially trained Peer Supporter (PS) who shares the lived experience of having an IDD than YA-IDD who are taught Ready to Ride by staff at their community services organization. The aspects of life being looked at are loneliness, satisfaction with social activities, travel skills, service use and access, employment, and health related quality of life.
The researchers think the following things will happen.
- YA-IDD who learn from a Peer Supporter will report significantly higher satisfaction with social activities, increased social connectedness and significantly less loneliness compared to YA who are taught organization staff.
- Both groups will learn the same amount of travel skills.
- YA-IDD who learn from a Peer Supporter will show larger increases in access to community-based services, transportation use, employment and health related services after 4 months than the YA taught by organizational staff.
Study Overview
Status
Intervention / Treatment
Detailed Description
This clinical trial has 2 aims.
Aim 1. Compare the effectiveness of peer support (R2R-PS) or staff delivered (R2R-S) Ready to Ride (R2R) travel intervention on loneliness, satisfaction with social activities, and travel skills (primary outcomes), and service use/access, transportation use, employment, social connectedness, and health related quality of life (secondary outcomes) for YA with IDD.
Hypothesis 1.1: YA receiving R2R-PS will report significantly higher satisfaction with social activities, increased social connectedness, and significantly less loneliness compared to YA receiving R2R-S.
Hypothesis 1.2: The travel skills demonstrated by YA receiving R2R-PS will be no worse than travel skills demonstrated by YA receiving R2R-S. We use a non-inferiority approach in response to community service organizations' request for evidence that peer support delivery does not lead to poor outcomes.
Hypothesis 1.3: YA receiving R2R-PS will demonstrate significantly greater improvements in service use/access, transportation use, employment, and health related quality of life 4 months post intervention compared to YA receiving R2R-S.
Aim 2: Evaluate heterogeneity of treatment response by assessing differences in R2R outcomes across characteristics of groups (race and ethnicity, anxiety, adaptive behavior) and context (transportation availability).
Hypothesis 2.1. There will be no difference in treatment effect for YA who identify as white, non-Hispanic and those identifying as Black, Hispanic, Asian, or other race/ethnicity.
Hypothesis 2.2. There will be greater gains for YA with lower levels of adaptive behavior completing R2R, based on past research that identified that participants with intellectual disabilities (ID) with lower levels of adaptive behaviors demonstrated greater improvements in transportation skills than those with a developmental disability but without an ID after receiving the R2R intervention.37 Hypothesis 2.3. There will be no difference in primary outcomes for YA living in areas with less transportation availability, given R2R's individualized travel training approach.
Hypothesis 2.4. There will be greater gains for YA in transportation outcomes who report lower levels of anxiety, given that anxiety in linked with reduced transportation use.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Beth Pfeiffer, PhD, OTR/L, BCP, FAOTA
- Phone Number: (215) 204-0828
- Email: elizabeth.pfeiffer@temple.edu
Study Contact Backup
- Name: Laura Elizabeth Slugg, BS
- Phone Number: 2154290005
- Email: laura.slugg@temple.edu
Study Locations
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Florida
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Gainesville, Florida, United States, 32611
- University of Florida
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Contact:
- Jessica Kramer, PhD, OTR/L
- Phone Number: 352-273-9672
- Email: Jessica.kramer@phhp.ufl.edu
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Institute on Community Integration
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Contact:
- Brian Abery, PhD
- Phone Number: 612-625-5592
- Email: abery001@umn.edu
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New Hampshire
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Durham, New Hampshire, United States, 03824
- University of New Hampshire
-
Contact:
- Ariel Schwartz, PhD, OTR
- Phone Number: (603) 862-4320
- Email: Ariel.Schwartz@unh.edu
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Contact:
- Melissa Diodati
- Phone Number: (603) 862-4320
- Email: Melissa.Diodati@unh.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between the ages of 18 to 27 years old during the start of the study
- Receives services at one of the eight community service organizations participating in the study.
- Meets the federal diagnosis of a developmental disability (DD)
- Qualifies for services related to their DD.
- Scores >28 on the Transportation Prescreening Assessment (indicating readiness for travel).
Exclusion Criteria:
- Independently uses public transportation >4 times/month.
- Is not able to independently mobilize through walking or use of a mobility device.
- Has significant non-corrected visual impairments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peer Support Delivery (R2R-PS)
|
The peer support delivery will be implemented by trained peer interventionists. Peer interventionists are individuals with lived experience of disability who are trained to provide structured support while sharing their experiences. They will deliver the Ready to Ride (R2R) training, an established evidence-based travel training program. The intervention includes a total of 16 sessions. Six sessions consist of structured lessons focused on travel safety, awareness, preparedness, and skill development. The remaining sessions involve community-based learning, where participants practice travel skills in real-world settings with varying levels of support. Peer interventionists will provide support through modeling, shared experience, encouragement, and guided practice. |
|
Active Comparator: Standard Delivery (R2R-S)
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The standard delivery will be implemented by non-peer staff serving as interventionists. These staff will deliver the Ready to Ride (R2R) training, an established evidence-based travel training program. The intervention includes a total of 16 sessions. Six sessions consist of structured lessons focused on travel safety, awareness, preparedness, and skill development. The remaining sessions involve community-based learning, where participants practice travel skills in real-world settings with varying levels of support provided by the interventionist. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progressive Evaluation of Travel Skills (PETS)
Time Frame: Data will be collected at 3 time points: 1) pre-test (<14 days prior to R2R), 2) post-test 1 (within 4 days of R2R completion) and 3) post-test 2 (4 months after R2R completion).
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The Progressive Evaluation of Travel Skills (PETS) ) is a direct observation measure of independent travel, as rated by the level of support needed for participants to complete transportation-related skills.
This tool has established content and construct validity with people with IDD.
The PETS will be administered by research staff masked to group assignment who will evaluate each participant on a standardized route.
The standardized routes have comparable difficulties across local public transportation systems.
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Data will be collected at 3 time points: 1) pre-test (<14 days prior to R2R), 2) post-test 1 (within 4 days of R2R completion) and 3) post-test 2 (4 months after R2R completion).
|
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NIH Toolbox® Item Bank v3.0 - Loneliness (Ages 18+) - Fixed Form (PROM)
Time Frame: Data will be collected at 3 time points: 1) pre-test (<14 days prior to R2R), 2) post-test 1 (within 4 days of R2R completion) and 3) post-test 2 (4 months after R2R completion).
|
Loneliness-NIH Toolbox® Item Bank v3.0 has 5 questions rated on a 5-point scale.
This measure has acceptable psychometric properties in the general population and is used in clinical populations and with people with disabilities, including IDD.
The tool includes questions that have detected differences in loneliness between individuals with and without IDD.
A total standard T-score will be used to analyze the data.
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Data will be collected at 3 time points: 1) pre-test (<14 days prior to R2R), 2) post-test 1 (within 4 days of R2R completion) and 3) post-test 2 (4 months after R2R completion).
|
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PROMIS Short Form v1.0 - Satisfaction with Participation in Discretionary Social Activities 7a (PROM)
Time Frame: Data will be collected at 3 time points: 1) pre-test (<14 days prior to R2R), 2) post-test 1 (within 4 days of R2R completion) and 3) post-test 2 (4 months after R2R completion).
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Satisfaction with Participation in Discretionary Social Activities-PROMIS Short Form v1.0 has 7 items that assess contentment with leisure interests and relationships with friends.
It has been used with adults with a range of disabilities, including IDD.
In a study with people with disabilities (including IDD), increased access to transportation predicted higher scores on this measure.
A total standard T-score will be used to analyze the data.
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Data will be collected at 3 time points: 1) pre-test (<14 days prior to R2R), 2) post-test 1 (within 4 days of R2R completion) and 3) post-test 2 (4 months after R2R completion).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Service attendance
Time Frame: Data will be collected at pre-testing retrospectively and then weekly after pre-test (<14 days prior to R2R) through post-test 2 (4 months after R2R completion).
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Service attendance will be collected retrospectively at pre-test and then weekly after pre-testing through the post-test 2 time period.
At pre-test, participants with assistance from family/staff or trusted adults/guardians when needed, will self-report the number of scheduled and missed primary, specialty, mental health, and dental appointments due to lack of transportation over the previous four months.
Following the completion of pre-test data collection, participants (or trusted adults/guardians) will receive weekly emails, texts or phones calls to respond to a monitoring survey.
From the weekly reports, we will calculate the total number of missed health and service appointments.
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Data will be collected at pre-testing retrospectively and then weekly after pre-test (<14 days prior to R2R) through post-test 2 (4 months after R2R completion).
|
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Accessibility Subscale of the Perceived Access of Health Care Services (PROM)
Time Frame: Data will be collected at 2 time points: 1) pre-test (<14 days prior to R2R) and 2) post-test 2 (4 months after R2R completion).
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Accessibility Subscale of the Perceived Access of Health Care Services is a PROM that assesses the perceived distance, time, and ability to get to and from the place of services.
The subscale has 4 items with response options on a 5-point Likert scale from "absolutely agree" to "absolutely disagree."
It has established content and construct validity and strong internal consistency.
Subscale total sum score will be used in analysis.
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Data will be collected at 2 time points: 1) pre-test (<14 days prior to R2R) and 2) post-test 2 (4 months after R2R completion).
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Transportation Use
Time Frame: Data will be collected weekly during R2R intervention through post-test 2 (4 months after R2R completion).
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Transportation Use data will be collected through weekly monitoring surveys that ask two brief questions about the use of public transportation in the past week.
The questions ask about the: 1) Use of public transportation on the goal route in the past week, and if that trip was taken independently or not and 2) Use of other public transportation fixed routes in the past week, and if that trip was taken independently or not.
This data will allow us to directly measure increased public transportation skills and use.
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Data will be collected weekly during R2R intervention through post-test 2 (4 months after R2R completion).
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Self-Reported Employment Data (status, hours/week, wages, percentage of missed work shifts)
Time Frame: Data will be collected at 2 time points: 1) pre-test (<14 days prior to R2R) and 2) post-test 2 (4 months after R2R completion).
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Descriptive information on employment status in the last 4 months will be collected from participants with assistance from family/staff if needed.
Data on employment status including working/maintaining work or not working/loss of work is collected at pre-test and post-test 2. If the participant is working, data will also be collected on number of hours worked weekly, hourly wage, and number of missed work shifts due to transportation.
Percentages will be calculated for the total sessions/missed sessions.
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Data will be collected at 2 time points: 1) pre-test (<14 days prior to R2R) and 2) post-test 2 (4 months after R2R completion).
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Quality of Life Questionnaire (QOL-Q)
Time Frame: Data will be collected at 3 time points: 1) pre-test (<14 days prior to R2R), 2) post-test 1 (within 4 days of R2R completion) and 3) post-test 2 (4 months after R2R completion).
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Quality of Life Questionnaire (QOL-Q) is a 40-item measure designed to assess subjective and objective aspects of quality of life among adults with intellectual and developmental disabilities. Items are organized into four domains based upon Schalock's conceptual framework for quality of life:
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Data will be collected at 3 time points: 1) pre-test (<14 days prior to R2R), 2) post-test 1 (within 4 days of R2R completion) and 3) post-test 2 (4 months after R2R completion).
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Social Connectedness Measure
Time Frame: Data will be collected at 3 time points: pre-test (<14 days prior to R2R), post-test 1 (within 4 days of R2R completion) and post-test 2 (4 months after R2R completion)
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Social Connectedness Measure is designed to assess the level to which individuals who use Home and Community Based Services (HCBS), including people with intellectual and developmental disabilities (IDD), form and maintain relationships with others as defined by the National Quality Forum.
The measure consists of three global and 13 specific items.
Questions address the presence and availability of others, which is not captured in the current measure of loneliness.
The response scale ranges from never/rarely to almost always/always.
The social connectedness measure is administered as an interview by a trained staff member.
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Data will be collected at 3 time points: pre-test (<14 days prior to R2R), post-test 1 (within 4 days of R2R completion) and post-test 2 (4 months after R2R completion)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adaptive Behavior Assessment System - Third Edition (ABAS-3 )
Time Frame: Data will be collected during pre-test (<14 days prior to R2R).
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Adaptive Behavior Assessment System Third Edition (ABAS-3) aligns with standards for diagnosing conditions such as IDD and has strong psychometrics when used with people with IDD across the life course.
Family or staff assess 11 essential skill areas within 3 major adaptive domains: 1) Conceptual, 2) Social, and 3) Practical.
It provides scaled scores, domain standard scores, and a general adaptive composite score, each associated with interpretive categories (e.g., below average).
Scores will be used for Aim 2 analysis.
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Data will be collected during pre-test (<14 days prior to R2R).
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PROMIS Anxiety Short Form
Time Frame: Data will be collected at pre-test (<14 days prior to R2R).
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PROMIS Anxiety Short Form is an 8-item survey rated using a 5-point Likert scale (Never, Almost Never, Sometimes, Often, Almost Always).
Higher scores indicate more anxiety.
The PROMIS Measurement System uses IRT-based scores to generate a precise score.
This measure was previously used with young adults with IDD, ages 18-26.
In these previous studies, our community engagement team preferred the youth/pediatric scale to the adult version due to its increased accessibility and clarity of items .
This measure has been validated in both clinical and non-clinical samples of youth ages 7-18 years old.
It demonstrates strong internal consistency (ω = 0.89) and test re-test reliability (r = 0.75, p < .001).
Additionally, it demonstrates strong convergent validity with measures of general anxiety and divergent validity with measures of specific anxieties (e.g., social, separation).
Scores will be used for Aim 2 analysis.
|
Data will be collected at pre-test (<14 days prior to R2R).
|
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Comprehensive Demographic Questionnaire
Time Frame: Data will be collected at pre-test (<14 days prior to R2R).
|
Comprehensive demographic questionnaire will document relevant individual and family characteristics (e.g., racial and ethnic identity, parent educational level) and other services received.
|
Data will be collected at pre-test (<14 days prior to R2R).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Beth Pfeiffer, PhD, OTR/L, BCP, FAOTA, Temple University
- Principal Investigator: Jessica Kramer, PhD, OTR/L, University of Florida
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDD-2024C1-37368 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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