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Набор скоро начнётся NCT07505121

Comparing the Impact of Peer Support vs. Staff-Delivered Transportation Interventions for Young Adults With Intellectual and Developmental Disabilities.

Без фазы С лечением Intellectual Disability, Mild to Moderate Developmental Disability

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: Ready to Ride - Standard Delivery, Ready to Ride - Peer Support Delivery.
Кому может быть актуально
Состояния в реестре: Intellectual Disability, Mild to Moderate, Developmental Disability. Базовые параметры: 18 лет — 27 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

Comparing Peer Support and Staff-Delivered Transportation Interventions for Young Adults With Intellectual and Developmental Disabilities (YA-IDD) on Loneliness, Social Participation, and Transportation Skills

Обзор

This clinical trial will look at whether young adults with intellectual and developmental disabilities (YA-IDD) have better outcomes when a travel training intervention called Ready to Ride (R2R) is taught by a specially trained Peer Supporter (PS) who shares the lived experience of having an IDD than YA-IDD who are taught Ready to Ride by staff at their community services organization. The aspects of life being looked at are loneliness, satisfaction with social activities, travel skills, service use and access, employment, and health related quality of life. The researchers think the following things will happen. 1. YA-IDD who learn from a Peer Supporter will report significantly higher satisfaction with social activities, increased social connectedness and significantly less loneliness compared to YA who are taught organization staff. 2. Both groups will learn the same amount of travel skills. 3. YA-IDD who learn from a Peer Supporter will show larger increases in access to community-based services, transportation use, employment and health related services after 4 months than the YA taught by organizational staff.

Подробное описание

This clinical trial has 2 aims.

Aim 1. Compare the effectiveness of peer support (R2R-PS) or staff delivered (R2R-S) Ready to Ride (R2R) travel intervention on loneliness, satisfaction with social activities, and travel skills (primary outcomes), and service use/access, transportation use, employment, social connectedness, and health related quality of life (secondary outcomes) for YA with IDD.

Hypothesis 1.1: YA receiving R2R-PS will report significantly higher satisfaction with social activities, increased social connectedness, and significantly less loneliness compared to YA receiving R2R-S.

Hypothesis 1.2: The travel skills demonstrated by YA receiving R2R-PS will be no worse than travel skills demonstrated by YA receiving R2R-S. We use a non-inferiority approach in response to community service organizations' request for evidence that peer support delivery does not lead to poor outcomes.

Hypothesis 1.3: YA receiving R2R-PS will demonstrate significantly greater improvements in service use/access, transportation use, employment, and health related quality of life 4 months post intervention compared to YA receiving R2R-S.

Aim 2: Evaluate heterogeneity of treatment response by assessing differences in R2R outcomes across characteristics of groups (race and ethnicity, anxiety, adaptive behavior) and context (transportation availability).

Hypothesis 2.1. There will be no difference in treatment effect for YA who identify as white, non-Hispanic and those identifying as Black, Hispanic, Asian, or other race/ethnicity.

Hypothesis 2.2. There will be greater gains for YA with lower levels of adaptive behavior completing R2R, based on past research that identified that participants with intellectual disabilities (ID) with lower levels of adaptive behaviors demonstrated greater improvements in transportation skills than those with a developmental disability but without an ID after receiving the R2R intervention.37 Hypothesis 2.3. There will be no difference in primary outcomes for YA living in areas with less transportation availability, given R2R's individualized travel training approach.

Hypothesis 2.4. There will be greater gains for YA in transportation outcomes who report lower levels of anxiety, given that anxiety in linked with reduced transportation use.

Вмешательства

  • Поведенческое Ready to Ride - Standard Delivery
    The standard delivery will be implemented by non-peer staff serving as interventionists. These staff will deliver the Ready to Ride (R2R) training, an established evidence-based travel training program. The intervention includes a total of 16 sessions. Six sessions consist of structured lessons focused on travel safety, awareness, preparedness, and skill development. The remaining sessions involve community-based learning, where participants practice travel skills in real-world settings with va
  • Поведенческое Ready to Ride - Peer Support Delivery
    The peer support delivery will be implemented by trained peer interventionists. Peer interventionists are individuals with lived experience of disability who are trained to provide structured support while sharing their experiences. They will deliver the Ready to Ride (R2R) training, an established evidence-based travel training program. The intervention includes a total of 16 sessions. Six sessions consist of structured lessons focused on travel safety, awareness, preparedness, and skill devel

Первичные конечные точки

  • Progressive Evaluation of Travel Skills (PETS) [Срок оценки: Data will be collected at 3 time points: 1) pre-test (<14 days prior to R2R), 2) post-test 1 (within 4 days of R2R completion) and 3) post-test 2 (4 months after R2R completion).]
  • NIH Toolbox® Item Bank v3.0 - Loneliness (Ages 18+) - Fixed Form (PROM) [Срок оценки: Data will be collected at 3 time points: 1) pre-test (<14 days prior to R2R), 2) post-test 1 (within 4 days of R2R completion) and 3) post-test 2 (4 months after R2R completion).]
  • PROMIS Short Form v1.0 - Satisfaction with Participation in Discretionary Social Activities 7a (PROM) [Срок оценки: Data will be collected at 3 time points: 1) pre-test (<14 days prior to R2R), 2) post-test 1 (within 4 days of R2R completion) and 3) post-test 2 (4 months after R2R completion).]
Вторичные конечные точки (6)
  • Service attendance [Срок оценки: Data will be collected at pre-testing retrospectively and then weekly after pre-test (<14 days prior to R2R) through post-test 2 (4 months after R2R completion).]
  • Accessibility Subscale of the Perceived Access of Health Care Services (PROM) [Срок оценки: Data will be collected at 2 time points: 1) pre-test (<14 days prior to R2R) and 2) post-test 2 (4 months after R2R completion).]
  • Transportation Use [Срок оценки: Data will be collected weekly during R2R intervention through post-test 2 (4 months after R2R completion).]
  • Self-Reported Employment Data (status, hours/week, wages, percentage of missed work shifts) [Срок оценки: Data will be collected at 2 time points: 1) pre-test (<14 days prior to R2R) and 2) post-test 2 (4 months after R2R completion).]
  • Quality of Life Questionnaire (QOL-Q) [Срок оценки: Data will be collected at 3 time points: 1) pre-test (<14 days prior to R2R), 2) post-test 1 (within 4 days of R2R completion) and 3) post-test 2 (4 months after R2R completion).]
  • Social Connectedness Measure [Срок оценки: Data will be collected at 3 time points: pre-test (<14 days prior to R2R), post-test 1 (within 4 days of R2R completion) and post-test 2 (4 months after R2R completion)]

Критерии участия

Критерии включения

  • Between the ages of 18 to 27 years old during the start of the study
  • Receives services at one of the eight community service organizations participating in the study.
  • Meets the federal diagnosis of a developmental disability (DD)
  • Qualifies for services related to their DD.
  • Scores >28 on the Transportation Prescreening Assessment (indicating readiness for travel).

Критерии исключения

  • Independently uses public transportation >4 times/month.
  • Is not able to independently mobilize through walking or use of a mobility device.
  • Has significant non-corrected visual impairments.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 3 центра
  • University of Florida — Gainesville
  • University of Minnesota Institute on Community Integration — Minneapolis
  • University of New Hampshire — Durham

Идентификаторы

NCT: NCT07505121 · IDD-2024C1-37368 · IDD-2024C1-37368

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗