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Clinical Trials/NCT07505121
NCT07505121
Not yet recruiting
Not Applicable

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

Temple University3 sites in 1 country325 target enrollmentStarted: May 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
325
Locations
3
Primary Endpoint
Progressive Evaluation of Travel Skills (PETS)

Overview

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. 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. Both groups will learn the same amount of travel skills.
  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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages
18 Years to 27 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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).

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.

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.

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).

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.

Secondary Outcomes

  • 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).)
  • Social Connectedness Measure(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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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