Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults

Alcohol Use Disorder Clinical Trial

Official title:

Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06337721
• Other study ID #: R01AA030786
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: August 2028

Study information

• Verified date: March 2024
• Source: University of California, Riverside
• Contact: ANDREW SUBICA, Ph.D.
• Phone: (951) 827-0200
• Email: asubica[@]medsch.ucr.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will: (1) refine and finalize the SPEAR intervention manual for preventing alcohol use disorders (AUD) and associated harms for Pacific Islander young adults; and (2) test SPEAR for efficacy by conducting a pretest-posttest randomized controlled trial (RCT).

Description:

Pacific Islander young adults bear elevated risk for alcohol use disorders (AUD) and alcohol-related harms, yet lack effective interventions to reduce their risk. Grounded in the social development model, this study will: (1) refine and finalize the SPEAR intervention manual for preventing alcohol use disorders (AUD) and associated harms for Pacific Islander young adults from existing evidence-based AUD prevention strategies; then (2) test SPEAR for efficacy by conducting a pretest-posttest randomized controlled trial (RCT) with at-risk Pacific Islander young adults across multiple Pacific Islander communities in the US.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: August 2028
• Est. primary completion date: May 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

1. Of full or part self-reported Pacific Islander heritage;

2. Fluent (oral and reading) in English

3. For young adult participants: 18 - 30 years of age

4. Current drinking (1+ drink in past 30 days)

5. High AUD risk (AUDIT-C score # 4 for men, # 3 for women)

6. Not currently in alcohol treatment (medication, therapeutic).

Exclusion Criteria:

1. Do not meet inclusion criteria

2. Are unwilling to participate

3. Fail to provide or retracts consent

4. Reside outside the target Pacific Islander communities

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcohol; Harmful Use
• Alcoholism

Intervention

Behavioral:
• SPEAR (Strategies for Pacific Empowerment and Alcohol Reduction)
This behavioral group intervention will consist of multiple group sessions to reduce AUDs and alcohol-related harms in Pacific Islander young adults. It will infuse culturally resonant narratives, language, and elements into existing evidence-based strategies.

Locations

Country	Name	City	State
United States	UC Riverside	Riverside	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Riverside

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heavy Episodic Drinking (HED) Days	# of Days of HED out of past 30 days	Up to 30 weeks
Secondary	Alcohol Consumption	7-day Alcohol Consumption	Up to 30 weeks