Peer Facilitated Waitlist Controlled Transportation Study

NCT06370767 | Recruiting

• 1 other identifier: 25634
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Serious Mental Illness

Outcome Measures

Primary Outcomes (8)

• Temple University Community Participation Measure

  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.

  Asked at baseline, 2-month, and 4-month follow-ups interviews.

• LASA Sedentary Behaviors Questionnaire

  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.

  Asked at baseline, 2-month, and 4-month follow-ups interviews.

• Transportation Appraisal Scale

  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.

  Asked at baseline, 2-month, and 4-month follow-ups interviews.

• Indego Skills Survey

  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.

  Asked at baseline, 2-month, and 4-month follow-ups interviews.

• SEPTA Skills Survey

  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

  Asked at baseline, 2-month, and 4-month follow-ups interviews.

• University of California, San Diego Performance-Based Skills Assessment (UPSA- Modified)

  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.

  Asked at baseline, 2-month, and 4-month follow-ups interviews.

• National Household Travel Survey

  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.

  Administered daily for 7 days after baseline, 2-month, and 4-month follow-up interviews.

• GPS

  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.

  GPS data collection will last for 14 days after initial baseline interviews and another 14 days after completion of the 8-week intervention.

Secondary Outcomes (7)

• Internalized Stigma of Mental Illness Inventory (ISMI) (Brief Version)

  Asked at baseline, 2-month, and 4-month follow-ups interviews.

• University of California, Los Angeles, Loneliness Scale

  Asked at baseline, 2-month, and 4-month follow-ups interviews.

• Pearlin Mastery Scale (Coping)

  Asked at baseline, 2-month, and 4-month follow-ups interviews.

• SF- 36 v2

  Asked at baseline, 2-month, and 4-month follow-ups interviews.

• The PERMA - Profiler Measure

  Asked at baseline, 2-month, and 4-month follow-ups interviews.

Study Arms (3)

Bike-Share

EXPERIMENTAL

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.

Behavioral: Bike-Share Travel Training

Public Transportation

EXPERIMENTAL

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.

Behavioral: Public Transportation Travel Training

Waitlist Control

NO INTERVENTION

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 BEHAVIORAL

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.

Bike-Share

Public Transportation Travel Training BEHAVIORAL

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.

Public Transportation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Pathways To Housing PA

Philadelphia, Pennsylvania, 19141, United States

RECRUITING

Central Study Contacts

Gillian A MacDonald, BA

CONTACT

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

Gretchen Snethen, PhD

CONTACT

gsnethen@temple.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to either start the intervention program immediately, or be placed on an 8-week waitlist. Once randomized, the participant will again be randomized into a treatment condition: 1) peer-mediated bikeshare training intervention; or 2) peer-mediated public travel training intervention. 20 participants from each condition who have not opted out of being in the GPS subsample will be randomly assigned to be invited to a GPS subgroup.

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 17, 2024
• Study Start: September 12, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Study files will be kept for seven years after the last publication of the data.

Locations

US (1)