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Идёт набор NCT06370767

Peer Facilitated Waitlist Controlled Transportation Study

Без фазы С лечением Serious Mental Illness

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Bike-Share Travel Training, Public Transportation Travel Training.
Кому может быть актуально
Состояния в реестре: Serious Mental Illness. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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.
  • Поведенческое 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.

Первичные конечные точки

  • Temple University Community Participation Measure [Срок оценки: Asked at baseline, 2-month, and 4-month follow-ups interviews.]
  • LASA Sedentary Behaviors Questionnaire [Срок оценки: Asked at baseline, 2-month, and 4-month follow-ups interviews.]
  • Transportation Appraisal Scale [Срок оценки: Asked at baseline, 2-month, and 4-month follow-ups interviews.]
  • Indego Skills Survey [Срок оценки: Asked at baseline, 2-month, and 4-month follow-ups interviews.]
  • SEPTA Skills Survey [Срок оценки: Asked at baseline, 2-month, and 4-month follow-ups interviews.]
  • University of California, San Diego Performance-Based Skills Assessment (UPSA- Modified) [Срок оценки: Asked at baseline, 2-month, and 4-month follow-ups interviews.]
  • National Household Travel Survey [Срок оценки: Administered daily for 7 days after baseline, 2-month, and 4-month follow-up interviews.]
  • GPS [Срок оценки: GPS data collection will last for 14 days after initial baseline interviews and another 14 days after completion of the 8-week intervention.]
Вторичные конечные точки (7)
  • Internalized Stigma of Mental Illness Inventory (ISMI) (Brief Version) [Срок оценки: Asked at baseline, 2-month, and 4-month follow-ups interviews.]
  • University of California, Los Angeles, Loneliness Scale [Срок оценки: Asked at baseline, 2-month, and 4-month follow-ups interviews.]
  • Pearlin Mastery Scale (Coping) [Срок оценки: Asked at baseline, 2-month, and 4-month follow-ups interviews.]
  • SF- 36 v2 [Срок оценки: Asked at baseline, 2-month, and 4-month follow-ups interviews.]
  • The PERMA - Profiler Measure [Срок оценки: Asked at baseline, 2-month, and 4-month follow-ups interviews.]
  • Recovery Assessment Scale (RAS) [Срок оценки: Asked at baseline, 2-month, and 4-month follow-ups interviews.]
  • Group Identification Scale (GIS) [Срок оценки: Asked at baseline, 2-month, and 4-month follow-ups interviews.]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Pathways To Housing PA — Philadelphia

Идентификаторы

NCT: NCT06370767 · 25634

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗