NCT04244461

Brief Summary

The objective of this planned research is to more fully test the efficacy of a very brief, inexpensive, single-session, and web-delivered personalized normative feedback (PNF) intervention evaluated in a successful pilot R34 study to prevent alcohol misuse and associated negative consequences, as well as increase behavioral health treatment seeking behaviors among a difficult to reach and treatment resistant veteran population. The investigators expand on successful pilot work by (1) building a large publicly available database of young veteran drinking and treatment seeking norms, (2) focusing on reaching veterans who have recently separated from the military and drink heavily but who have not recently sought any behavioral health treatment, (3) evaluating how an enhanced intervention offering PNF content specifically related to treatment seeking affects preparatory behaviors and actual treatment initiation, and (4) testing hypothesized mediators and moderators of intervention drinking and treatment initiation outcomes relevant for this population. In Aim 1, the investigators will add to a large database of drinking norms for the population by collecting drinking and treatment seeking information from veterans underrepresented in the pilot, such as female veterans (total sample N = 2,500). In Aim 2, investigators then use these norms in a randomized controlled trial of the PNF intervention designed to reach heavy drinking young veterans who are not currently receiving behavioral health care (N = 800) and test if additional feedback about treatment seeking can help promote treatment initiation among this treatment resistant group. Outcomes at 3, 6, 9, and 12 months are compared for participants receiving an enhanced PNF condition (N = 400) to an attention-only control condition (N = 400). In Aim 3, the investigators test mediators of intervention efficacy on drinking outcomes (i.e., changes in perceived norms, increases in treatment initiation) and explore moderators of outcomes to determine if the brief intervention works better for veteran participants based on age, gender, reasons for drinking (social versus coping), perceived stigma, posttraumatic stress disorder disorder and depression symptoms, and solitary drinking. This project is funded by the NIAAA grant R01AA026575.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
754

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
2.7 years until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

2.1 years

First QC Date

January 24, 2020

Last Update Submit

July 28, 2025

Conditions

Keywords

alcoholmental healthtreatment initiation

Outcome Measures

Primary Outcomes (3)

  • Drinking frequency

    Number of days reported any drinking on the timeline followback

    Past month (30 days)

  • Drinks of drinking days

    Average number of drinks reported during drinking days on the timeline followback

    Past month (30 days)

  • 21-item Brief Young Adult Alcohol Consequences Questionnaire

    Number of 21 assessed alcohol consequences experienced (yes/no). Yes responses are summed to yield a score on this measure. Higher scores indicate experience of a greater number of consequences. Scores range from 0 (no consequences) to 21 (experience of all 21 consequences)

    Past month (30 days)

Study Arms (2)

Personalized normative feedback

EXPERIMENTAL

Personalized feedback about drinking behavior compared to peers

Behavioral: Personalized Normative Feedback

Control

NO INTERVENTION

Control participants will receive content similar in length but different in content from the PNF (i.e., non-drinking focused). These participants will receive information based on their actual and perceived behavior of playing video games, a strategy used in prior PNF work to balance attention to non-targeted behaviors.

Interventions

The personalized normative feedback (PNF) focuses on behavioral norms, where participants see (1) how their perceptions compare to other same-gender veterans' actual drinking and (2) how their actual drinking compares to other same-gender veterans' actual drinking. The format of the intervention highlights typical days per week, drinks per occasion, and binge drinking as per traditional PNF interventions. PNF will also contain a video description of theories of normative influence (e.g., how individuals are affected by perceptions) and a description of the normative data sample. Participants also see enhanced PNF content that will focus on sharing with participants treatment information that the investigators obtained from a pilot sample.

Personalized normative feedback

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Veterans aged 18 to 40 who has separated/discharged from military service from the Air Force, Army, Marine Corps, or Navy
  • Not currently affiliated with active duty service or in the reserves or guard units
  • Able to read English (also a requirement of military service)
  • Access to a computer, Internet, and personal email address
  • No appointments in the past six months and no pending appointments with a mental health professional or medical doctor for treatment of concerns related to alcohol use, other substance use, PTSD, depression, or other mental health concerns
  • AUDIT-C scores of 3 or higher (for females) or 4 or higher (for males), which represents a sex-specific positive screen for hazardous and harmful alcohol use, as well as a possible AUD in civilian and military samples
  • Separation from the military within the past 5 years.

You may not qualify if:

  • None besides not meeting eligibility criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (1)

  • Pedersen ER, Davis JP, Hummer JF, Bouskill K, Buch KD, Shute IM, Fitzke RE, Tran DD, Neighbors C, Saba S. Reducing Alcohol Misuse and Promoting Treatment Initiation Among Veterans Through a Brief Internet-Based Intervention: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Aug 22;13:e59993. doi: 10.2196/59993.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 28, 2020

Study Start

September 30, 2022

Primary Completion

October 30, 2024

Study Completion

November 30, 2024

Last Updated

July 31, 2025

Record last verified: 2025-07

Locations