- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT05768217
Устойчивость сообщества Коллективная эффективность Вмешательство
Коллективное эффективное вмешательство по обеспечению устойчивости сообщества (CRCEI) для предотвращения насилия в сообществе - кластерное рандомизированное контролируемое исследование
This study will evaluate, via a cluster-randomized controlled trial, the effectiveness of a community-centered intervention that promotes thriving and resiliency to reduce community violence.
Обзор исследования
Статус
Условия
Подробное описание
This study will evaluate, via a cluster-randomized controlled trial, the effectiveness of an innovative community-centered intervention that promotes thriving and resiliency to reduce community violence. In collaboration with community partners, this study will implement a Community Resiliency Collective Efficacy Intervention (CRCEI) to engage community members in dialogue on neighborhood transformation, racial and gender equity, community leadership, and organizing for social change. Facilitating discussion and community organizing within neighborhoods about child and youth thriving is expected to increase individual and neighborhood levels of collective efficacy and reduce community violence. Using a community-partnered participatory approach, this study will use a Community Thriving Matrix tool to engage youth and adult community members in ongoing dialogue on neighborhood transformation, community leadership, and organizing for social change. This focus on envisioning and creating neighborhoods in which children and adolescents can thrive is expected to translate to increased individual and neighborhood levels of collective efficacy as well as violence reduction. Comparison neighborhoods will receive health education sessions as a control intervention. The proposed study involves diverse neighborhoods in the Pittsburgh region and collecting survey data from youth (ages 13-19 years) and adult community participants (both male and female identified). Interviews with a sub-sample of community residents and facilitators and community site leads as well as observations of intervention delivery will provide qualitative information on processes of program implementation. This study will provide the first rigorous evaluation of this community-level prevention approach.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Соединенные Штаты, 15213
- University of Pittsburgh
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- youth age 13 years old and up (all genders)
- adults 18 years and older (all genders)
- reside in neighborhoods selected to participate in the study
Exclusion Criteria:
-
individuals younger than 13 years old
- individuals residing outside of participating neighborhoods
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Community Resiliency Collective Efficacy Intervention (CRCEI)
Community Resiliency Collective Efficacy Intervention (CRCEI) to engage community members in dialogue on thriving, community leadership, and organizing for social change (9 sessions). |
The Community Resiliency Collective Efficacy Intervention (CRCEI) will involve community members in dialogue on thriving, community leadership, and organizing for social change. Participants in the intervention condition will be asked to participate in 2 sessions of discussions about community thriving and a 7-week training program on the following topics: Building on the Strengths of Your Community, Collective Efficacy and its Effects on Violence Prevention & Community Mental Health, Non-threatening Peaceful Intervention Principles and Strategies: Part One, Non-threatening Peaceful Intervention Principles and Strategies: Part Two, Safety and Roles of Police and Community in Intervening, Active/Effective listening and non-violent communication skills, and Community Resources and Indirect Intervention. |
|
Активный компаратор: Health Education Sessions
Comparison neighborhoods will receive health education sessions as a control intervention. (9 sessions) |
Comparison neighborhoods will receive health education sessions across a variety of community-identified health topics as a control intervention. (9 sessions) |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change from baseline in perceptions of neighborhood collective efficacy and community cohesion
Временное ограничение: Change from baseline to approximately 12 months after baseline
|
Composite Measure mean score (range 1 - 5; 1 is low and 5 is best) of neighborhood-level perceptions of collective efficacy and community cohesion |
Change from baseline to approximately 12 months after baseline
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Community incidence of violence in 12 month period
Временное ограничение: Change from 1 year period before baseline to approximately 12 months after baseline
|
number of incidents of violence, i.e., assaults, gun violence, referrals to child protective services, compared to control neighborhoods. |
Change from 1 year period before baseline to approximately 12 months after baseline
|
|
Community incidence of violence in 12 month period
Временное ограничение: Change from 1 year period before baseline to approximately 2 years after baseline
|
number of incidents of violence, i.e., assaults, gun violence, referrals to child protective services, compared to control neighborhoods. |
Change from 1 year period before baseline to approximately 2 years after baseline
|
|
Change from baseline in collective efficacy and neighborhood social norms
Временное ограничение: Change from baseline to approximately 12 months after baseline
|
Composite Collective Efficacy Measure mean score (range 1-5; 1 is lowest and 5 is best) of individual-level collective efficacy and neighborhood social norms |
Change from baseline to approximately 12 months after baseline
|
|
Number of self-reported events of violence exposure
Временное ограничение: Change from baseline to approximately 12 months after baseline
|
count of individual-level events of violence exposure |
Change from baseline to approximately 12 months after baseline
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Alison Culyba, MD, PhD, MPH, University of Pittsburgh
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- STUDY22100193
- U01CE003524-01 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
We do not plan to make a fully documented, publicly available data set on a website for download because while individual participant data are de-identified, it could be possible to discern the neighborhoods or sites from the dataset and therefore compromise the anonymity of the data. Therefore, we will make the data available only to selected researchers who apply for access. The application must document a legitimate public health use or research question for the data, and the applicant must sign a pledge to keep all data private and to make no attempt to identify individual subjects. This use of the data is consistent with the planned language of the voluntary consent for participation agreed and in accordance with IRB policy.
Сроки обмена IPD
12 months after data collection is completed.
Критерии совместного доступа к IPD
Data sharing agreement must be completed with investigators and the University of Pittsburgh.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .