Clinical trial NCT05363878: Development of a Culturally Grounded, Trauma-Informed Alcohol Intervention With a Reserve-Dwelling First Nation Group
Official title: Development of a Culturally Grounded, Trauma-Informed Alcohol Intervention With a Reserve-Dwelling First Nation Group
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Trauma, Psychological
Historical Trauma
Lead sponsor: University of Rhode Island
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time Line Follow-Back (TLFB)
timeFrame: End of treatment (up to 12 weeks following baseline)
measure: Time Line Follow-Back (TLFB)
timeFrame: 3-months post treatment completion
measure: Time Line Follow-Back (TLFB)
timeFrame: 6-months post treatment completion
measure: Historical Loss and Associated Symptoms Scale
timeFrame: 3-months post treatment completion
measure: Historical Loss and Associated Symptoms Scale
timeFrame: 6-months post treatment completion
measure: Historical Loss and Associated Symptoms Scale
timeFrame: End of treatment (up to 12 weeks following baseline)
Secondary outcomes:
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: End of treatment (up to 12 weeks following baseline)
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: 3-months post treatment completion
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: 6-months post treatment completion
measure: Cultural Connectedness Scale
timeFrame: End of treatment (up to 12 weeks following baseline)
measure: Cultural Connectedness Scale
timeFrame: 3-months post treatment completion
measure: Cultural Connectedness Scale
timeFrame: 6-months post treatment completion
measure: Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)
timeFrame: End of treatment (up to 12 weeks following baseline)
measure: Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)
timeFrame: 3-months post treatment completion
measure: Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)
timeFrame: 6-months post treatment completion
Other outcomes:
Locations:
city: Fredericton
country: Canada
facility: Kingsclear First Nation
state: New Brunswick
Study officials:
affiliation: University of Rhode Island
name: Nichea S Spillane, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rhode Island
name: Nicole H Weiss, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: