Development of a Culturally Grounded, Trauma-Informed Alcohol Intervention With a Reserve-Dwelling First Nation Group (Native HEALTH)
Primary Purpose
Alcohol Drinking, Trauma, Psychological, Historical Trauma
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Native HEALTH
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Drinking
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Native HEALTH Condition
Wait-List Control
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05363878
First Posted
April 22, 2022
Last Updated
August 15, 2022
Sponsor
University of Rhode Island
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT05363878
Brief Title
Development of a Culturally Grounded, Trauma-Informed Alcohol Intervention With a Reserve-Dwelling First Nation Group
Acronym
Native HEALTH
Official Title
Development of a Culturally Grounded, Trauma-Informed Alcohol Intervention With a Reserve-Dwelling First Nation Group
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Rhode Island
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Trauma, Psychological, Historical Trauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Native HEALTH Condition
Arm Type
Experimental
Arm Title
Wait-List Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Native HEALTH
Other Intervention Name(s)
To be named based on community feedback
Intervention Description
This application proposes the development and initial test of a culturally grounded, trauma informed intervention for alcohol use.
Primary Outcome Measure Information:
Title
Time Line Follow-Back (TLFB)
Description
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.
Time Frame
Baseline
Title
Time Line Follow-Back (TLFB)
Description
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.
Time Frame
End of treatment (up to 12 weeks following baseline)
Title
Time Line Follow-Back (TLFB)
Description
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.
Time Frame
3-months post treatment completion
Title
Time Line Follow-Back (TLFB)
Description
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.
Time Frame
6-months post treatment completion
Title
Alcohol Use Disorder Identification Test (AUDIT)
Description
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.
Time Frame
Baseline
Title
Alcohol Use Disorder Identification Test (AUDIT)
Description
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.
Time Frame
End of treatment (up to 12 weeks following baseline)
Title
Alcohol Use Disorder Identification Test (AUDIT)
Description
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.
Time Frame
3-months post treatment completion
Title
Alcohol Use Disorder Identification Test (AUDIT)
Description
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.
Time Frame
6-months post treatment completion
Title
Historical Loss Scale
Description
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.
Time Frame
Baseline
Title
Historical Loss Scale
Description
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.
Time Frame
End of treatment (up to 12 weeks following baseline)
Title
Historical Loss Scale
Description
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.
Time Frame
3-months post treatment completion
Title
Historical Loss Scale
Description
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.
Time Frame
6-months post treatment completion
Title
Historical Loss and Associated Symptoms Scale
Description
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.
Time Frame
Baseline
Title
Historical Loss and Associated Symptoms Scale
Description
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.
Time Frame
End of treatment (up to 12 weeks following baseline)
Title
Historical Loss and Associated Symptoms Scale
Description
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.
Time Frame
3-months post treatment completion
Title
Historical Loss and Associated Symptoms Scale
Description
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.
Time Frame
6-months post treatment completion
Title
Satisfaction with Life Scale (SWLS)
Description
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.
Time Frame
Baseline
Title
Satisfaction with Life Scale (SWLS)
Description
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.
Time Frame
End of treatment (up to 12 weeks following baseline)
Title
Satisfaction with Life Scale (SWLS)
Description
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.
Time Frame
3-months post treatment completion
Title
Satisfaction with Life Scale (SWLS)
Description
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.
Time Frame
6-months post treatment completion
Title
Cultural Connectedness Scale
Description
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.
Time Frame
Baseline
Title
Cultural Connectedness Scale
Description
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.
Time Frame
End of treatment (up to 12 weeks following baseline)
Title
Cultural Connectedness Scale
Description
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.
Time Frame
3-months post treatment completion
Title
Cultural Connectedness Scale
Description
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.
Time Frame
6-months post treatment completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nichea S Spillane, Ph.D.
Phone
4018744252
Email
nspillane@uri.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole H Weiss, Ph.D.
Phone
4012775492
Email
nicole_weiss@uri.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nichea S Spillane, Ph.D.
Organizational Affiliation
University of Rhode Island
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicole H Weiss, Ph.D.
Organizational Affiliation
University of Rhode Island
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development of a Culturally Grounded, Trauma-Informed Alcohol Intervention With a Reserve-Dwelling First Nation Group
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