Clinical trial NCT06370767: Peer Facilitated Waitlist Controlled Transportation Study
Official title: Enhancing Community Mobility in Individuals With Serious Mental Illnesses Through Peer-Facilitated Travel Training: A Two-armed Waitlist Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Serious Mental Illness
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Temple University Community Participation Measure
timeFrame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
measure: LASA Sedentary Behaviors Questionnaire
timeFrame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
measure: Transportation Appraisal Scale
timeFrame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
measure: Indego Skills Survey
timeFrame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
measure: SEPTA Skills Survey
timeFrame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
measure: University of California, San Diego Performance-Based Skills Assessment (UPSA- Modified)
timeFrame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
measure: National Household Travel Survey
timeFrame: Administered daily for 7 days after baseline, 2-month, and 4-month follow-up interviews.
measure: GPS
timeFrame: 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:
measure: Internalized Stigma of Mental Illness Inventory (ISMI) (Brief Version)
timeFrame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
measure: University of California, Los Angeles, Loneliness Scale
timeFrame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
measure: Pearlin Mastery Scale (Coping)
timeFrame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
measure: SF- 36 v2
timeFrame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
measure: The PERMA - Profiler Measure
timeFrame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
measure: Recovery Assessment Scale (RAS)
timeFrame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
measure: Group Identification Scale (GIS)
timeFrame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Pathways To Housing PA
state: Pennsylvania
Study officials:
References: