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Clinical Trials/NCT06370767
NCT06370767
Recruiting
N/A

Enhancing Community Mobility in Individuals With Serious Mental Illnesses Through Peer-Facilitated Travel Training: A Two-armed Waitlist Controlled Trial

Temple University1 site in 1 country180 target enrollmentSeptember 12, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Serious Mental Illness
Sponsor
Temple University
Enrollment
180
Locations
1
Primary Endpoint
Temple University Community Participation Measure
Status
Recruiting
Last Updated
last year

Overview

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.

Detailed Description

This project proposes using a two-armed, waitlist controlled trial to test the effectiveness of peer-facilitated travel interventions and their ability to enhance community mobility and increase feelings of self-efficacy in individuals with serious mental illness (SMI). The first intervention arm is an 8-week bikeshare intervention, which consists of individual trainings on using a bike sharing program; the second intervention arm is an 8-week public transportation intervention, which consists of individual trainings for using public transportation in the Philadelphia area. The investigators seek to enroll a total of 180 individuals from community mental health agencies in the Philadelphia area and expect recruitment to take 3 years. Eligible participants will be individuals who meet criteria indicating that they have an SMI, are between the ages of 18-65, and are both willing and able to learn to use public transportation and ride a bicycle. Data will be collected via face-to-face or web-based video call interviews at 3 time points: baseline, 2-months post-baseline, and 4-months post-baseline. Participants will also complete short surveys about their travel behaviors over the phone in the seven days after each interview. There will also be a subsample of participants who will provide additional GPS data.

Registry
clinicaltrials.gov
Start Date
September 12, 2024
End Date
May 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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

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.

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.

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.

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.

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.

Secondary Outcomes

  • 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.)
  • 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.)
  • Pearlin Mastery Scale (Coping)(Asked at baseline, 2-month, and 4-month follow-ups interviews.)
  • Recovery Assessment Scale (RAS)(Asked at baseline, 2-month, and 4-month follow-ups interviews.)
  • Group Identification Scale (GIS)(Asked at baseline, 2-month, and 4-month follow-ups interviews.)

Study Sites (1)

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