Peer Facilitated Waitlist Controlled Transportation Study

Serious Mental Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06370767
• Other study ID #: 25634
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Temple University
• Contact: Gillian A MacDonald, BA
• Phone: ?(267) 225-0218?
• Email: gillian.macdonald[@]temple.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Serious Mental Illness

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Internalized Stigma of Mental Illness Inventory (ISMI) (Brief Version)	This scale is designed to measure self-stigma among persons with psychiatric disorders. The brief measure takes the strongest items from each of the subscales of the full measure. The subscales and item examples include: Alienation (e.g. "Having a mental illness has spoiled my life"), Stereotype Endorsement (e.g., "Mentally ill people tend to be violent"), Discrimination Experience (e.g., "People discriminate against me because I have a mental illness"), Social Withdrawal (e.g., " I don't talk about myself as much because I don't want to burden others with my mental illness"), and Stigma Resistance (e.g., "I can have a good, fulfilling life, despite my mental illness") that is scored on a 4-point Likert scale. For this research, it will be used to measure changes in internalized stigma over time.	Asked at baseline, 2-month, and 4-month follow-ups interviews.
Secondary	University of California, Los Angeles, Loneliness Scale	These 3 questions are only being given to people who report having a mental illness. The questions related to how often people feel socially isolated or lonely. Response options range from 1) hardly ever, 2) some of the time, and 3) often. Responses (3) indicate increased loneliness and more "hardly ever" responses indicate less loneliness.	Asked at baseline, 2-month, and 4-month follow-ups interviews.
Secondary	Pearlin Mastery Scale (Coping)	This is 7-item mastery scale to assess participants' feeling of control over their lives. Items are asked on a 4-point Likert scale and include statement like "I have little control over the things that happen to me" and "What happens to me in the future mostly depends on me." For this research, it will be used to measure changes in participants' abilities to cope with symptoms over time.	Asked at baseline, 2-month, and 4-month follow-ups interviews.
Secondary	SF- 36 v2	This measure asks about health status and physical capability of daily activities. Participants are asked to rank their health over the last week, including experiences of pain, sickness, tiredness, and physical activities like walking or carrying. For this research, it will be used to measure self-perceived physical health.	Asked at baseline, 2-month, and 4-month follow-ups interviews.
Secondary	The PERMA - Profiler Measure	The PERMA Profiler is based on the five pillars of wellbeing: positive emotion, engagement, relationships, meaning, accomplishment). Items are asked on a 10-pint scale and include items such as "How often do you schieve the important goals you have set for yourself?", "How lonely do you feel in your daily life?", and "To what extent do you feel loved?". For this research, it will be used to measure perceived quality of life.	Asked at baseline, 2-month, and 4-month follow-ups interviews.
Secondary	Recovery Assessment Scale (RAS)	Three subscale from the RAS will be used: 1) reliance on others, 2) confidence and hope, and 3) willingness to ask for help. Responses range from strongly disagree (1) to strongly agree (5). Scores can range from 16-80 with higher scores indicating greater recovery, reliance on others, confidence, and willingness to ask for help.	Asked at baseline, 2-month, and 4-month follow-ups interviews.
Secondary	Group Identification Scale (GIS)	This scale measures intergroup relations and self-concept of group identification. Participants will be asked on a 7-point Likert scale how the agree or disagree with statements comparing them to other SEPTA and bikeshare riders. For this research, it will be used to measure participants' feeling of belonging in the groups of public transportation users, bikeshare, and their local community	Asked at baseline, 2-month, and 4-month follow-ups interviews.