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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Rhode Island

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years of age

Used alcohol in the past week

Self-identify as a First Nation member

Reside within the partner community

Disqualifiers

Experiencing current psychotic symptoms

High scores (>10) on the Clinical Institute Withdrawal Assessment for Alcohol, Revised

Trial design

Design model

Parallel

Treatments tested in this trial

  • Native HEALTH

    Behavioral

    This application proposes the development and initial test of a culturally grounded, trauma informed intervention for alcohol use.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Native HEALTH ConditionExperimental treatment 1 intervention
Group B: Wait-List ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
End of treatment (up to 12 weeks following baseline)
2

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.

Time frame
3-months post treatment completion
3

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.

Time frame
6-months post treatment completion
4

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.

Time frame
3-months post treatment completion

Secondary outcomes

1

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.

Time frame
End of treatment (up to 12 weeks following baseline)
2

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.

Time frame
3-months post treatment completion
3

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.

Time frame
6-months post treatment completion
4

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.

Time frame
End of treatment (up to 12 weeks following baseline)

Other outcomes

Sponsors and contacts

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University of Rhode Island

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator