Recruiting

Alcohol Intervention

Sponsor:

University of Rhode Island

Code:

NCT05363878

Conditions

Alcohol Drinking

Trauma, Psychological

Historical Trauma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Native HEALTH

Study Details

Brief 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.

Conditions

Alcohol Drinking

Trauma, Psychological

Historical Trauma

Study ID

NCT05363878

Start date

Jan 13, 2025

Status verified date

Apr, 2025

Completion date

Sep 29, 2025

Anticipated

Primary completion date

Mar 26, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • At least 18 years of age
  • Used alcohol in the past week
  • Self-identify as a First Nation member
  • Reside within the partner community
  • Want to cut down or stop alcohol use

Exclusion Criteria:

  • Experiencing current psychotic symptoms
  • High scores (>10) on the Clinical Institute Withdrawal Assessment for Alcohol, Revised

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Native HEALTH Condition

Participants randomized to the Native HEALTH condition will complete the Native HEALTH intervention. This is a newly developed cultural program designed to reduce harm from alcohol use and improve quality of life among people in Kingsclear First Nation.

no intervention: Wait-List Control

Participants randomized to the wait-list control group will complete the Native HEALTH intervention after two months.

Interventions

Native HEALTH

This application proposes the development and initial test of a culturally grounded, trauma informed intervention for alcohol use.

Primary outcome measure

  • Time Line Follow-Back (TLFB) [ Time Frame: End of treatment (up to 12 weeks following baseline) ]
  • Time Line Follow-Back (TLFB) [ Time Frame: 3-months post treatment completion ]
  • Time Line Follow-Back (TLFB) [ Time Frame: 6-months post treatment completion ]
  • Historical Loss and Associated Symptoms Scale [ Time Frame: 3-months post treatment completion ]
  • Historical Loss and Associated Symptoms Scale [ Time Frame: 6-months post treatment completion ]
  • Historical Loss and Associated Symptoms Scale [ Time Frame: End of treatment (up to 12 weeks following baseline) ]

Central Contacts and Locations

Central contacts

Nichea S Spillane, Ph.D.

4018744252nspillane@uri.edu

Nicole H Weiss, Ph.D.

4012775492nicole_weiss@uri.edu

Locations

Kingsclear First Nation

Recruiting

Fredericton, New Brunswick, Canada, E3E 1K3

Contacts

Nichea Spillane, PhD

8593219918nspillane@asu.edu

More Information

Sponsor

University of Rhode Island

Last update posted

Apr 24, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rhode Island on 2025-04-24.