Recruiting

Observational Study

Sponsor:

Temple University

Code:

NCT06370767

Conditions

Serious Mental Illness

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Bike-Share Travel Training

Public Transportation Travel Training

Study Details

Brief summary:

The goal of this clinical trial is to test the effectiveness of a peer-facilitated travel intervention in adults with serious mental illnesses. This project aims to address the following hypotheses:

1. Individuals with SMI receiving either of the two peer-mediated travel training transportation interventions will experience an increase in transportation self-efficacy and transportation skills.
2. Participants in the intervention arms will increase their transport utilization, participate in significantly more activities in the community, and make significantly more trips in the community.
3. Individuals with SMI receiving peer-mediated travel training interventions will retain post-test levels of community participation and self-efficacy 2 months after intervention.

Participants will be assigned to an 8-week travel-training intervention either using a bike-share program or public transportation. All participants will complete three data-collection research interviews.

Conditions

Serious Mental Illness

Study ID

NCT06370767

Start date

Sep 12, 2024

Status verified date

Oct, 2024

Completion date

May, 2025

Anticipated

Primary completion date

May, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • are between the ages of 18 and 65
  • are diagnosed with a SMI (confirmed via the MINI)
  • score at least an 8 on a travel skills assessment
  • indicates that they can ride a bicycle
  • have expressed interest in using a bikeshare and public transportation
  • are able to provide informed consent

Exclusion Criteria:

  • score less than 8 on a travel skills assessment
  • express no interest in independent transportation
  • are non-English speaking individuals
  • are unable to provide consent
  • are living in a setting where mobility and participation is restricted
  • have a limiting physical condition that would prevent their ability to ride a bicycle independently

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Bike-Share

Participants in this arm will participate in an 8-week bikeshare training program, using Indego, the bike sharing service in Philadelphia. The first sessions will be aimed at increasing knowledge of the bike share program and the procedures for utilizing it successfully. Then participants will meet with a peer support specialist, who will help facilitate individualized route planning and independent ride support. Peer support specialists will use motivational interviewing during these individual sessions in order to help participants identify personally meaningful motivations for participation and to enhance their sense of self-efficacy.

experimental: Public Transportation

An established travel-training program developed for individuals with disabilities, including those with SMI, serves as the curriculum for the public transportation intervention arm. Participants will use SEPTA, the public transportation provider in Philadelphia and surrounding areas. We will offer an 8-week intervention which will include instruction on foundational skills needed to travel on public transportation and 1-on-1 direct training in using public transportation. Participants will meet twice weekly for direct instruction and role-playing sessions to cover the core components and the latter weeks of intervention will be focused on individual travel training instruction provided by the peer support interventionists, with participants and peer support interventionists meeting for two travel trips each week.

no intervention: Waitlist Control

Half of the participants in either arm (bike-share or public transportation) will be randomly assigned to either begin the intervention immediately, or be placed on a waitlist, serving as a control arm. The waitlist will be 8 weeks long, the same timeline as the intervention. After the eighth week, participants assigned to the waitlist will then begin the intervention for the next 8 weeks. Participants assigned to starting the intervention immediately will then be placed on the waitlist for the second-8 weeks of the total study enrollment.

Interventions

Bike-Share Travel Training

Half of the participants not assigned to the waitlist will begin the bike-share intervention arm immediately after the baseline research interview. The bike-share arm will last for 8 weeks and be delivered by a community peer specialist. Half of the participants assigned to the waitlist will begin the bike-share intervention arm after an 8-week waiting period.

Public Transportation Travel Training

Half of the participants not assigned to the waitlist or bike-share arm will begin the public transportation intervention arm immediately after the baseline research interview. The public transportation arm will last for 8 weeks and be delivered by a community peer specialist. Half of the participants assigned to the waitlist will begin the public transportation intervention arm after an 8-week waiting period.

Primary outcome measure

  • Temple University Community Participation Measure [ Time Frame: Asked at baseline, 2-month, and 4-month follow-ups interviews. ]
  • LASA Sedentary Behaviors Questionnaire [ Time Frame: Asked at baseline, 2-month, and 4-month follow-ups interviews. ]
  • Transportation Appraisal Scale [ Time Frame: Asked at baseline, 2-month, and 4-month follow-ups interviews. ]
  • Indego Skills Survey [ Time Frame: Asked at baseline, 2-month, and 4-month follow-ups interviews. ]
  • SEPTA Skills Survey [ Time Frame: Asked at baseline, 2-month, and 4-month follow-ups interviews. ]
  • University of California, San Diego Performance-Based Skills Assessment (UPSA- Modified) [ Time Frame: Asked at baseline, 2-month, and 4-month follow-ups interviews. ]
  • National Household Travel Survey [ Time Frame: Administered daily for 7 days after baseline, 2-month, and 4-month follow-up interviews. ]
  • GPS [ Time Frame: GPS data collection will last for 14 days after initial baseline interviews and another 14 days after completion of the 8-week intervention. ]

Central Contacts and Locations

Central contacts

Gillian A MacDonald, BA

‪(267) 225-0218‬gillian.macdonald@temple.edu

Gretchen Snethen, PhD

gsnethen@temple.edu

Locations

Pathways To Housing PA

Recruiting

Philadelphia, Pennsylvania, United States, 19141

More Information

Sponsor

Temple University

Last update posted

Nov 1, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Temple University on 2024-11-01.