Clinical Trial

Development of a Culturally Grounded, Trauma-Informed Alcohol Intervention With a Reserve-Dwelling First Nation Group

Study acronym: NativeHEALTH
Recruiting
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Summary
The objective of this project is to develop and obtain preliminary data on a culturally grounded, trauma-informed alcohol intervention. The specific aims are to (1) use Community-Based Participatory Research methods to deepen partnerships with First Nation through capacity-building and knowledge sharing; (2) collect and apply qualitative data to develop a culturally grounded, trauma-informed alcohol intervention that is focused on historical trauma for use with a First Nation sample; and (3) conduct a pilot RCT study to examine acceptability, sustainability, and initial efficacy data of the intervention compared to waitlist control. This work is important, timely, and innovative. Addressing alcohol use has important implications for the health of Indigenous populations.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-05-02; most recent amendment 2025-04-21.
Status change: Not Yet Recruiting → Recruiting 2025-04-21
Trial Details
NCT Number NCT05363878
Lead Sponsor University of Rhode Island
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions Alcohol Drinking, Trauma, Psychological, Historical Trauma
Enrollment 60 participants
Start Date 2025-01-13
Primary Completion 2025-03-26 (estimated)
Study Completion 2025-09-29 (estimated)
Updated on ClinicalTrials.gov 2025-04-24