NCT07505121

Brief Summary

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.

  1. 1.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.
  2. 2.Both groups will learn the same amount of travel skills.
  3. 3.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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P75+ for not_applicable

Timeline
48mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026Jun 2030

First Submitted

Initial submission to the registry

March 10, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

4.1 years

First QC Date

March 10, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

Travel Training InterventionYoung AdultsIntellectual DisabilityDevelopmental DisabilityTransportationPeer Support

Outcome Measures

Primary Outcomes (3)

  • Progressive Evaluation of Travel Skills (PETS)

    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.

    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).

  • NIH Toolbox® Item Bank v3.0 - Loneliness (Ages 18+) - Fixed Form (PROM)

    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.

    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).

  • PROMIS Short Form v1.0 - Satisfaction with Participation in Discretionary Social Activities 7a (PROM)

    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.

    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).

Secondary Outcomes (6)

  • Service attendance

    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).

  • Accessibility Subscale of the Perceived Access of Health Care Services (PROM)

    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).

  • Transportation Use

    Data will be collected weekly during R2R intervention through post-test 2 (4 months after R2R completion).

  • Self-Reported Employment Data (status, hours/week, wages, percentage of missed work shifts)

    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).

  • Quality of Life Questionnaire (QOL-Q)

    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).

  • +1 more secondary outcomes

Other Outcomes (3)

  • Adaptive Behavior Assessment System - Third Edition (ABAS-3 )

    Data will be collected during pre-test (<14 days prior to R2R).

  • PROMIS Anxiety Short Form

    Data will be collected at pre-test (<14 days prior to R2R).

  • Comprehensive Demographic Questionnaire

    Data will be collected at pre-test (<14 days prior to R2R).

Study Arms (2)

Peer Support Delivery (R2R-PS)

EXPERIMENTAL
Behavioral: Ready to Ride - Peer Support Delivery

Standard Delivery (R2R-S)

ACTIVE COMPARATOR
Behavioral: Ready to Ride - Standard Delivery

Interventions

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.

Standard Delivery (R2R-S)

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.

Peer Support Delivery (R2R-PS)

Eligibility Criteria

Age18 Years - 27 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Florida

Gainesville, Florida, 32611, United States

Location

University of Minnesota Institute on Community Integration

Minneapolis, Minnesota, 55455, United States

Location

University of New Hampshire

Durham, New Hampshire, 03824, United States

Location

MeSH Terms

Conditions

Intellectual DisabilityDevelopmental Disabilities

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Beth Pfeiffer, PhD, OTR/L, BCP, FAOTA

    Temple University

    PRINCIPAL INVESTIGATOR
  • Jessica Kramer, PhD, OTR/L

    University of Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth Pfeiffer, PhD, OTR/L, BCP, FAOTA

CONTACT

Laura Elizabeth Slugg, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
At least one research staff masked to group assignment at each of the 4 research sites. Primary Investigators will be masked unless a situation arises during data collection that requires them to know which group a participant was assigned to. The project statistician/Co-I will be masked to organization and individual participants and complete randomization using a random number generator. Each community service organization will be assigned a letter (A to H) to maintain masking.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: We will conduct a Hybrid Type 1, two-arm, clinical randomized trial while gathering information on implementation processes to inform strategies for adoption and sustainability.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2026

First Posted

April 1, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

We will submit de-identified IPD data and associated documentation to the Interuniversity Consortium for Political and Social Research (ICPSR) within 24 months after the end date of the project, enabling other researchers in the field to analyze the data and publish from it following a 12-month embargo period. Specifically, we will be self-publishing the data through the openICPSR research data-sharing service (www.openicpsr.org), which assigns a persistent DOI and DDI-compliant metadata. This will enable independent reanalysis, verification, and secondary research.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
We will submit de-identified IPD data and associated documentation to the Interuniversity Consortium for Political and Social Research (ICPSR) within 24 months after the end date of the project, enabling other researchers in the field to analyze the data and publish from it following a 12-month embargo period.
Access Criteria
We will be self-publishing the data through the openICPSR research data-sharing service (www.openicpsr.org) which is accessible to anyone, as it is a publicly available dataset. The dataset will be publicly accessible upon embargo expiration. Users will be required to cite the dataset and adhere to ethical use standards. If the repository requires a click-through data-use statement, we will enable it to reinforce responsible use.

Locations