NCT06370767 · Temple University
Peer Facilitated Waitlist Controlled Transportation Study
What this study is about
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.
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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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
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 measures
Temple University Community Participation Measure
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
Measures engagement in 29 participation areas, if those areas are important to them, how often they did them and if it was enough, not enough, or too much. Higher reported frequency across a greater number of areas indicates higher rates of participation. Higher number of activities reported as being important and done enough indicate greater sufficiency of participation.
LASA Sedentary Behaviors Questionnaire
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
This survey measures the time spent doing various activities that are usually completed while sitting down. For a 24-hour period on both weekdays and weekends, the reporting asks "How much time do you spend (from when you wake up until you go to bed) doing the following?" For this research, it will be used to measure changes in sedentary behaviors over time.
Transportation Appraisal Scale
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
This measure assesses participants' ability to use public transportation and travel around their community. Items are asked on a 4-point scale, asking how much help is needed with various travel tasks, including reading schedules to plan a trip and knowing how to pay for transportation. For this research, it will be used to measure changes in transportation self-efficacy over time.
Indego Skills Survey
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
This is an open-ended questionnaire to assess participants' skills with navigating the Indeo bike-sharing program in Philadelphia. Researchers give points to participants' responses on questions pertaining to the access, payment, and return of the bikes. For this research, it will be used to measure Indego skills at the time of the interview.
SEPTA Skills Survey
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
Similar to the Indego Skills Survey, this is an open-ended questionnaire to assess participants' skills with navigating Philadelphia's public transit system, SEPTA. Researchers give points to participants' responses on questions pertaining to the access, payment, and choosing the correct bus or subway stop. For this research, it will be used to measure SEPTA skills at the time of the interview
University of California, San Diego Performance-Based Skills Assessment (UPSA- Modified)
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
This role-play measurement was designed for individuals with mental health challenges to assess participant's real-word abilities. The Transportation subscale uses a pitcutre of a bus schedule and asks the participant to correctly identify the departure, destination, and costs of rides. For this research, it will be used to measure SEPTA and bikeshare planning skills.
National Household Travel Survey
Time frame: Administered daily for 7 days after baseline, 2-month, and 4-month follow-up interviews.
This is a daily, self-report measure that captures the amount and types of trips a participant takes in one day. The log will be administered over the phone by a research assistant, asking how many trips were taken, the type of trip (medical appointment, work, social outing, etc), the mode of transportation (personal vehicle, public transit, bike, walk, etc) and the general location of the trip.
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.
A subsample of participants will carry a cellphone that will track their movements in the community using a GPS app. Outcome measures include: 1) number of unique destination, 2) total number of destinations, and 3) total distance traveled. A subsample of participants will carry a cellphone that will track their movements in the community using a GPS app. Outcome measures include: 1) number of unique destination, 2) total number of destinations, and 3) total distance traveled. A subsample of participants will carry a cellphone that will track their movements in the community using a GPS app. Outcome measures include: 1) number of unique destination, 2) total number of destinations, and 3) total distance traveled. A subsample of participants will carry a cellphone that will track their movements in the community using a GPS app. Outcome measures include: 1) number of unique destination, 2) total number of destinations, and 3) total distance traveled.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 1, 2024 · Source of record for eligibility and locations