Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
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) |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
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) |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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) |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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) |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
