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

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Drinking; Trauma, Psychological; Historical Trauma
• Intervention / Treatment: Behavioral: Native HEALTH

Detailed Description

Using a Community-Based Participatory Research (CBPR) approach, the investigators will work with community partners to develop a culturally grounded, trauma-informed alcohol intervention. The investigators will collaborate with community partners to design, implement, and evaluate this intervention program. A strength of this approach is that in using existing structures, settings, and resources, this intervention will be able to be more easily sustained over time. This work will occur in two stages. Stage 1a, will occur in two phases; first, talking circles will be used to develop the intervention/manual. In this stage, the investigators will explore their place in the community, identifying important stakeholders, recognizing strengths and resources at the local level, pinpointing settings in the community where research and intervention can potentially or already is taking place, and developing a strong communication and collaboration plan that involves community members and researchers to allow for an exchange of knowledge that is bi-directional. Talking circles will identify Indigenous knowledge and practices related to historical trauma and alcohol use. Benchmark: The end of this first phase will yield a manual. Results from the talking circle will provide important knowledge on the targets, techniques, and mechanisms of change for the intervention, as well as the structure of the intervention, including number and length of sessions, treatment setting, and format (group or individual). Second, the investigators will conduct an open pilot trail that will provide information on the manual, delivery of the intervention, and acceptability of participants. Community members (n = 5) will be recruited to go through the intervention and provide qualitative feedback after each session that will be used to further refine intervention components. Benchmark: Open pilot participants will help further refine the manual for delivery in the randomized pilot trial. During Stage 1b (pilot randomized trial), the investigators will test the feasibility, acceptability, and potential efficacy of the program in a randomized, 2-group pilot clinical trial. Participants (N=60) will be randomized to either a wait-list-control (WLC) group (n=30) or to the culturally grounded, trauma-informed alcohol intervention (n=30). Alcohol outcomes will be assessed at baseline, completion, and 3 and 6 months post-completion. The investigators will evaluate whether the program shows promise relative to the WLC group in terms of alcohol consumption, historical losses and response, well-being, and community connectedness. Benchmarks: Major intermediate objectives are: 1) adequate recruitment volume, 2) achievement of targeted enrollment goals, and 3) follow-up rates >= 85% in Stage 1b pilot trial. In the unlikely scenario that recruitment lags, the investigators will first increase field efforts at flyering and following up recruitment letters. If recruitment continues to lag, the investigators have existing relationships with other Indigenous communities in the nearby area that share the same cultural heritage and language. If follow-up rates lag, telephone follow-ups will be intensified and follow-up incentives will be increased as allowed by budgetary constraints. The investigators will also consider truncating 6-month follow-ups to include only those items necessary for alcohol use.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nichea S Spillane, Ph.D.; Phone Number: 4018744252; Email: nspillane@uri.edu
• Study Contact Backup: Name: Nicole H Weiss, Ph.D.; Phone Number: 4012775492; Email: nicole_weiss@uri.edu

Study Locations

• Canada
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3E 1K3
      • Recruiting
      • Kingsclear First Nation
      • Contact: Nichea Spillane, PhD; Phone Number: 8593219918; Email: nspillane@asu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Native HEALTH; This application proposes the development and initial test of a culturally grounded, trauma informed intervention for alcohol use.; Other Names: To be named based on community feedback
No Intervention: Wait-List Control; Participants randomized to the wait-list control group will complete the Native HEALTH intervention after two months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use Disorder Identification Test (AUDIT)	The AUDIT is a 10-item self-report instrument designed to identify individuals for whom the use of alcohol places them at risk for alcohol problems or who are experiencing such problems. The AUDIT items ask about the past year, although a few items have no specific time reference. AUDIT total scores can range from 0 to 40, and scores of 8 or above have been used to identify individuals who may be at risk for or who are experiencing alcohol problems. Considerable empirical evidence supports the instrument's internal consistency.	End of treatment (up to 12 weeks following baseline)
Alcohol Use Disorder Identification Test (AUDIT)	The AUDIT is a 10-item self-report instrument designed to identify individuals for whom the use of alcohol places them at risk for alcohol problems or who are experiencing such problems. The AUDIT items ask about the past year, although a few items have no specific time reference. AUDIT total scores can range from 0 to 40, and scores of 8 or above have been used to identify individuals who may be at risk for or who are experiencing alcohol problems. Considerable empirical evidence supports the instrument's internal consistency.	3-months post treatment completion
Alcohol Use Disorder Identification Test (AUDIT)	The AUDIT is a 10-item self-report instrument designed to identify individuals for whom the use of alcohol places them at risk for alcohol problems or who are experiencing such problems. The AUDIT items ask about the past year, although a few items have no specific time reference. AUDIT total scores can range from 0 to 40, and scores of 8 or above have been used to identify individuals who may be at risk for or who are experiencing alcohol problems. Considerable empirical evidence supports the instrument's internal consistency.	6-months post treatment completion
Cultural Connectedness Scale	The Cultural Connectedness Scale is a 10-item scale designed to measure three components of cultural connectedness for First Nations individuals: identity, traditions, and spirituality. Participants respond "yes" or "no" to five items assessing whether they engage in cultural practices, rate their agreement with one statement using a 5-point scale ranging from strongly disagree to strongly agree, and rate the frequency of their engagement in cultural activities using four items on a 5-point scale ranging from never to every day. Items are summed to create scale scores ranging from 0 to 25, with higher scores indicating greater cultural connectedness. This scale has been used with adequate reliability.	End of treatment (up to 12 weeks following baseline)
Cultural Connectedness Scale	The Cultural Connectedness Scale is a 10-item scale designed to measure three components of cultural connectedness for First Nations individuals: identity, traditions, and spirituality. Participants respond "yes" or "no" to five items assessing whether they engage in cultural practices, rate their agreement with one statement using a 5-point scale ranging from strongly disagree to strongly agree, and rate the frequency of their engagement in cultural activities using four items on a 5-point scale ranging from never to every day. Items are summed to create scale scores ranging from 0 to 25, with higher scores indicating greater cultural connectedness. This scale has been used with adequate reliability.	3-months post treatment completion
Cultural Connectedness Scale	The Cultural Connectedness Scale is a 10-item scale designed to measure three components of cultural connectedness for First Nations individuals: identity, traditions, and spirituality. Participants respond "yes" or "no" to five items assessing whether they engage in cultural practices, rate their agreement with one statement using a 5-point scale ranging from strongly disagree to strongly agree, and rate the frequency of their engagement in cultural activities using four items on a 5-point scale ranging from never to every day. Items are summed to create scale scores ranging from 0 to 25, with higher scores indicating greater cultural connectedness. This scale has been used with adequate reliability.	6-months post treatment completion
Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)	The Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) is a ten-item self-report measure of health-related quality of life. This questionnaire was developed by the NIH to assess five domains: physical function, fatigue, pain, emotional distress, and social health -- all of which are compared relative to United States normative scores. Items are rated on a five-point likert scale.	End of treatment (up to 12 weeks following baseline)
Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)	The Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) is a ten-item self-report measure of health-related quality of life. This questionnaire was developed by the NIH to assess five domains: physical function, fatigue, pain, emotional distress, and social health -- all of which are compared relative to United States normative scores. Items are rated on a five-point likert scale.	3-months post treatment completion
Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)	The Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) is a ten-item self-report measure of health-related quality of life. This questionnaire was developed by the NIH to assess five domains: physical function, fatigue, pain, emotional distress, and social health -- all of which are compared relative to United States normative scores. Items are rated on a five-point likert scale.	6-months post treatment completion

Collaborators and Investigators

• Sponsor: University of Rhode Island
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Nicole H Weiss, Ph.D., University of Rhode Island; Principal Investigator: Nichea S Spillane, Ph.D., University of Rhode Island

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Actual): March 26, 2025
• Study Completion (Estimated): September 29, 2025

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Drinking Behavior; Stress Disorders, Traumatic; Psychological Trauma; Historical Trauma; Alcohol Drinking; Wounds and Injuries
• Other Study ID Numbers: R34AA028587 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No