NCT01694082

Brief Summary

Tertiary Health Research Intervention Via Email (THRIVE; Kypri et al., 2009), originally utilized with Australian students, is unique in that it contains efficacious components derived from motivational interviewing (e.g., personalized feedback) and cognitive behavioral therapy (protective behavioral strategies), yet is very brief and has established efficacy. This study aims to test versions of THRIVE tailored to American college students. In addition to replicating original results with THRIVE, we will also test versions containing unique subsets of protective behavioral strategies to reduce alcohol consumption. The primary hypothesis is that versions of THRIVE will be associated with lower overall alcohol consumption than an assessment and brief brochure control condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

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

September 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 16, 2014

Status Verified

June 1, 2014

Enrollment Period

1.1 years

First QC Date

September 20, 2012

Last Update Submit

June 12, 2014

Conditions

Alcohol UseHeavy DrinkingNegative Consequences of Alcohol Use

Keywords

brief interventionweb-based interventionscomputer-based interventionsharm reductionyoung adultcollege student

Outcome Measures

Primary Outcomes (3)

  • Frequency of alcohol use

    1-month post-intervention

  • Protective behavioral strategy use

    1-month post-intervention

  • Overall Weekly Alcohol Consumption

    1-month post-intervention

Secondary Outcomes (3)

  • Frequency of heavy drinking days

    1-month post-intervention

  • Frequency of alcohol use

    6-months post-intervention

  • Overall weekly alcohol consumption

    6-months post-intervention

Study Arms (4)

THRIVE replication

EXPERIMENTAL

Participants in this condition receive THRIVE with a full list of direct and indirect protective behavioral strategies to reduce alcohol consumption.

Behavioral: THRIVE

THRIVE direct strategies

EXPERIMENTAL

Participants in this condition receive THRIVE including a subset of protective behavioral strategies that are directly related to alcohol drinking.

Behavioral: THRIVE

THRIVE indirect strategies

EXPERIMENTAL

Participants in this condition receive THRIVE including a subset of protective behavioral strategies that are indirectly related to alcohol drinking.

Behavioral: THRIVE

Brief brochure and assessment control

SHAM COMPARATOR

Participants will answer the same survey questions as participants in the THRIVE conditions, but will receive a brief alcohol-related brochure with only didactic content rather than the intervention components received by participants randomized to THRIVE conditions.

Behavioral: Brief brochure and assessment control

Interventions

THRIVEBEHAVIORAL

THRIVE stands for (Tertiary Health Research Intervention Via Email). Participants complete questions related to demographics and their alcohol use and receive brief personalized feedback based on this information, in addition to protective behavioral strategies, facts about alcohol and information about available resources to reduce their alcohol use.

Also known as: Tertiary Health Research Intervention Via Email
THRIVE direct strategiesTHRIVE indirect strategiesTHRIVE replication
Brief brochure and assessment controlBEHAVIORAL
Brief brochure and assessment control

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Must be a current student at Albertus Magnus College in New Haven, CT

You may not qualify if:

  • Under 18 years of age
  • years of age or older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • Frohe T, Gebru NM, Wilson B, Leeman RF. Is a very brief web-based intervention with focus on protective behavioral strategies efficacious in reducing impaired control over alcohol in undergraduates? Exp Clin Psychopharmacol. 2025 Feb;33(1):1-7. doi: 10.1037/pha0000737. Epub 2024 Aug 15.

    PMID: 39146062DERIVED

MeSH Terms

Conditions

Alcohol DrinkingHarm Reduction

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Robert F Leeman, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychiatry

Study Record Dates

First Submitted

September 20, 2012

First Posted

September 26, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2013

Study Completion

June 1, 2014

Last Updated

June 16, 2014

Record last verified: 2014-06

Locations

US(1)