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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Alcohol Drinking, Trauma, Psychological, Historical Trauma

Intervention / Treatment
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* Behavioral: Native HEALTH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Native HEALTH Condition<br> | Behavioral: Native HEALTH<br>* This application proposes the development and initial test of a culturally grounded, trauma informed intervention for alcohol use.<br>* Other names: To be named based on community feedback;|
| No Intervention: Wait-List Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Line Follow-Back (TLFB) | The TLFB interview will be used to assess alcohol and other substance 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. | Baseline | 
| Time Line Follow-Back (TLFB) | The TLFB interview will be used to assess alcohol and other substance 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 and other substance 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 and other substance 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 | 
| 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. | 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. | 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 | 
| Historical Loss Scale | To measure historical trauma, the Historical Loss Scale will be administered. This scale quantifies 12 types of losses that American Indian tribes may have experienced in the past, and asks how often participants think about each of these losses. Response options range from 1 (never) to 6 (several times a day), such that higher scores indicate more frequent thoughts regarding historical losses. | Baseline | 
| Historical Loss Scale | To measure historical trauma, the Historical Loss Scale will be administered. This scale quantifies 12 types of losses that American Indian tribes may have experienced in the past, and asks how often participants think about each of these losses. Response options range from 1 (never) to 6 (several times a day), such that higher scores indicate more frequent thoughts regarding historical losses. | End of treatment (up to 12 weeks following baseline) | 
| Historical Loss Scale | To measure historical trauma, the Historical Loss Scale will be administered. This scale quantifies 12 types of losses that American Indian tribes may have experienced in the past, and asks how often participants think about each of these losses. Response options range from 1 (never) to 6 (several times a day), such that higher scores indicate more frequent thoughts regarding historical losses. | 3-months post treatment completion | 
| Historical Loss Scale | To measure historical trauma, the Historical Loss Scale will be administered. This scale quantifies 12 types of losses that American Indian tribes may have experienced in the past, and asks how often participants think about each of these losses. Response options range from 1 (never) to 6 (several times a day), such that higher scores indicate more frequent thoughts regarding historical losses. | 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. | 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. | 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 | 
| Satisfaction with Life Scale (SWLS) | The SWLS is a 5-item scale designed to measure global cognitive judgements of one's life satisfaction. Participants rate how much they agree or disagree with each of the five items using a 7-point scale that ranges from strongly agree to strongly disagree. Items are summed to create a scale score ranging from 7 to 35, with higher scores indicating greater satisfaction with one's life. The SWLS is considered among the most reliable scales of life satisfaction and subjective well-being. It has been used in studies specifically examining well-being among American Indian and First Nations individuals with good reliability. | Baseline | 
| Satisfaction with Life Scale (SWLS) | The SWLS is a 5-item scale designed to measure global cognitive judgements of one's life satisfaction. Participants rate how much they agree or disagree with each of the five items using a 7-point scale that ranges from strongly agree to strongly disagree. Items are summed to create a scale score ranging from 7 to 35, with higher scores indicating greater satisfaction with one's life. The SWLS is considered among the most reliable scales of life satisfaction and subjective well-being. It has been used in studies specifically examining well-being among American Indian and First Nations individuals with good reliability. | End of treatment (up to 12 weeks following baseline) | 
| Satisfaction with Life Scale (SWLS) | The SWLS is a 5-item scale designed to measure global cognitive judgements of one's life satisfaction. Participants rate how much they agree or disagree with each of the five items using a 7-point scale that ranges from strongly agree to strongly disagree. Items are summed to create a scale score ranging from 7 to 35, with higher scores indicating greater satisfaction with one's life. The SWLS is considered among the most reliable scales of life satisfaction and subjective well-being. It has been used in studies specifically examining well-being among American Indian and First Nations individuals with good reliability. | 3-months post treatment completion | 
| Satisfaction with Life Scale (SWLS) | The SWLS is a 5-item scale designed to measure global cognitive judgements of one's life satisfaction. Participants rate how much they agree or disagree with each of the five items using a 7-point scale that ranges from strongly agree to strongly disagree. Items are summed to create a scale score ranging from 7 to 35, with higher scores indicating greater satisfaction with one's life. The SWLS is considered among the most reliable scales of life satisfaction and subjective well-being. It has been used in studies specifically examining well-being among American Indian and First Nations individuals with good reliability. | 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. | 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. | 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 |