NCT06337721

Brief 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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Sep 2024Aug 2028

First Submitted

Initial submission to the registry

March 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

3.7 years

First QC Date

March 22, 2024

Last Update Submit

March 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Heavy Episodic Drinking (HED) Days

    \# of Days of HED out of past 30 days

    Up to 30 weeks

Secondary Outcomes (1)

  • Alcohol Consumption

    Up to 30 weeks

Study Arms (2)

SPEAR

EXPERIMENTAL

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)

Control

NO INTERVENTION

This control group arm will be compared to the SPEAR intervention.

Interventions

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.

SPEAR

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Of full or part self-reported Pacific Islander heritage;
  • Fluent (oral and reading) in English
  • For young adult participants: 18 - 30 years of age
  • Current drinking (1+ drink in past 30 days)
  • High AUD risk (AUDIT-C score # 4 for men, # 3 for women)
  • Not currently in alcohol treatment (medication, therapeutic).

You may not qualify if:

  • Are unwilling to participate
  • Fail to provide or retracts consent
  • Reside outside the target Pacific Islander communities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Riverside

Riverside, California, 91784, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • ANDREW SUBICA

    UC Riverside

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ANDREW SUBICA, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Will conduct a randomized controlled trial of the SPEAR intervention vs. control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2024

First Posted

March 29, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

March 29, 2024

Record last verified: 2024-03

Locations