- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT05768217
Zbiorowa interwencja dotycząca skuteczności społeczności w zakresie odporności
Zbiorowa interwencja w zakresie skuteczności odporności społeczności (CRCEI) w celu zapobiegania przemocy w społeczności – randomizowana, kontrolowana próba klastrowa
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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Pennsylvania
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
- University of Pittsburgh
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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:
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individuals younger than 13 years old
- individuals residing outside of participating neighborhoods
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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. |
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Aktywny komparator: 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) |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from baseline in perceptions of neighborhood collective efficacy and community cohesion
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Community incidence of violence in 12 month period
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Alison Culyba, MD, PhD, MPH, University of Pittsburgh
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- STUDY22100193
- U01CE003524-01 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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.
Ramy czasowe udostępniania IPD
12 months after data collection is completed.
Kryteria dostępu do udostępniania IPD
Data sharing agreement must be completed with investigators and the University of Pittsburgh.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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