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

NCT05363878 | Recruiting DMC

• 1 other identifier: R34AA028587
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Time Line Follow-Back (TLFB)

  The TLFB interview will be used to assess alcohol use. The TLFB interview is a calendar-assisted structured interview which provides a way to cue memory so that accurate recall is enhanced. A structured interview of drinking behavior has been found to be the most reliable and valid method of assessing prior alcohol use. The TLFB interview has excellent reliability and validity. It will provide data on the percentage of drinking days, average number of standard drinks consumed per drinking day, drinks consumed per day, and the percentage of heavy drinking days.

  End of treatment (up to 12 weeks following baseline)

• Time Line Follow-Back (TLFB)

  The TLFB interview will be used to assess alcohol use. The TLFB interview is a calendar-assisted structured interview which provides a way to cue memory so that accurate recall is enhanced. A structured interview of drinking behavior has been found to be the most reliable and valid method of assessing prior alcohol use. The TLFB interview has excellent reliability and validity. It will provide data on the percentage of drinking days, average number of standard drinks consumed per drinking day, drinks consumed per day, and the percentage of heavy drinking days.

  3-months post treatment completion

• Time Line Follow-Back (TLFB)

  The TLFB interview will be used to assess alcohol use. The TLFB interview is a calendar-assisted structured interview which provides a way to cue memory so that accurate recall is enhanced. A structured interview of drinking behavior has been found to be the most reliable and valid method of assessing prior alcohol use. The TLFB interview has excellent reliability and validity. It will provide data on the percentage of drinking days, average number of standard drinks consumed per drinking day, drinks consumed per day, and the percentage of heavy drinking days.

  6-months post treatment completion

• Historical Loss and Associated Symptoms Scale

  To measure symptoms associated with historical trauma, the Historical Loss Associated Symptoms Scale will be administered. This scales quantify 12 types of symptoms that American Indian people may experience when thinking about historical loss. Participants rate how often they experience each symptom, with response options ranging from 1 (Never) to 5 (Always), such that higher scores indicate more severe historical loss associated symptoms.

  3-months post treatment completion

• Historical Loss and Associated Symptoms Scale

  To measure symptoms associated with historical trauma, the Historical Loss Associated Symptoms Scale will be administered. This scales quantify 12 types of symptoms that American Indian people may experience when thinking about historical loss. Participants rate how often they experience each symptom, with response options ranging from 1 (Never) to 5 (Always), such that higher scores indicate more severe historical loss associated symptoms.

  6-months post treatment completion

• Historical Loss and Associated Symptoms Scale

  To measure symptoms associated with historical trauma, the Historical Loss Associated Symptoms Scale will be administered. This scales quantify 12 types of symptoms that American Indian people may experience when thinking about historical loss. Participants rate how often they experience each symptom, with response options ranging from 1 (Never) to 5 (Always), such that higher scores indicate more severe historical loss associated symptoms.

  End of treatment (up to 12 weeks following baseline)

Secondary Outcomes (9)

• Alcohol Use Disorder Identification Test (AUDIT)

  End of treatment (up to 12 weeks following baseline)

• Alcohol Use Disorder Identification Test (AUDIT)

  3-months post treatment completion

• Alcohol Use Disorder Identification Test (AUDIT)

  6-months post treatment completion

• Cultural Connectedness Scale

  End of treatment (up to 12 weeks following baseline)

• Cultural Connectedness Scale

  3-months post treatment completion

Study Arms (2)

Native HEALTH Condition

EXPERIMENTAL

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.

Behavioral: Native HEALTH

Wait-List Control

NO INTERVENTION

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

Interventions

Native HEALTH BEHAVIORAL

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

Also known as: To be named based on community feedback

Native HEALTH Condition

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Rhode Island: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Kingsclear First Nation

Fredericton, New Brunswick, E3E 1K3, Canada

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking; Psychological Trauma; Historical Trauma

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Nichea S Spillane, Ph.D.

  University of Rhode Island

  PRINCIPAL INVESTIGATOR

• Nicole H Weiss, Ph.D.

  University of Rhode Island

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nichea S Spillane, Ph.D.

CONTACT

4018744252; nspillane@uri.edu

Nicole H Weiss, Ph.D.

CONTACT

4012775492; nicole_weiss@uri.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 6, 2022
• Study Start: January 13, 2025
• Primary Completion: March 26, 2025
• Study Completion: September 29, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)