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

March 22, 2024 updated by: University of California, Riverside
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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Riverside, California, United States, 91784
        • UC Riverside

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPEAR
This arm will consist of the SPEAR (Strategies for Pacific Empowerment and Alcohol Reduction) behavioral group intervention to reduce AUDs and alcohol-related harms in Pacific Islander young adults.
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.
No Intervention: Control
This control group arm will be compared to the SPEAR intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heavy Episodic Drinking (HED) Days
Time Frame: Up to 30 weeks
# of Days of HED out of past 30 days
Up to 30 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Consumption
Time Frame: Up to 30 weeks
7-day Alcohol Consumption
Up to 30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Riverside

Investigators

  • Principal Investigator: ANDREW SUBICA, UC Riverside

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AA030786 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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