NCT05143073

Brief Summary

The purpose of this study is to evaluate an online educational tool that will help individuals better understand alcohol use disorder, risk factors, and genetic risk information and to better understand participant's beliefs regarding alcohol use disorder. This study does not involve genetic testing. Investigators will not be giving participants any personalized genetic feedback as part of the study; however, investigators will ask participants to imagine that they receive different hypothetical genetic risk scores and respond to survey items.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
338

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 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

Study Start

First participant enrolled

November 15, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2021

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

28 days

First QC Date

November 19, 2021

Last Update Submit

January 18, 2022

Conditions

Keywords

Genetic FeedbackPersonalized Risk InformationAlcohol Use DisorderEducational InterventionPolygenic Risk ScoresHealth Beliefs

Outcome Measures

Primary Outcomes (2)

  • Understanding of genetic risk scores for alcohol use disorder

    Understanding of genetic risk scores for alcohol use disorder will be assessed after each of the three hypothetical scenarios in which participants receive a low genetic risk score, average genetic risk score, and high genetic risk score. Participants will respond to a series of true/false/don't know statements to assess understanding and interpretation of each genetic risk score. Responses will be scored as correct or incorrect and summed to create an overall score.

    1 hour

  • Perceived susceptibility of developing alcohol use disorder

    Perceived susceptibility for developing alcohol use disorder assesses an individual's belief about their chance of developing alcohol use disorder in the future. This will be measured using the Health Beliefs about Mental Illness Instrument. The items will be assessed immediately after the educational intervention and after each hypothetical genetic risk score. Five items from the Health Beliefs about Mental Illness Instrument will be scored from 1 (strongly disagree) to 5 (strongly agree) and averaged together to create an overall score.

    1 hour

Secondary Outcomes (7)

  • Perceived barriers to risk reducing behavior

    1 hour

  • Perceived severity of alcohol use disorder

    1 hour

  • Genetic knowledge

    1 hour

  • Future intentions

    1 hour

  • Hypothetical psychological impact of receiving a genetic risk score

    1 hour

  • +2 more secondary outcomes

Study Arms (3)

No educational materials

NO INTERVENTION

No educational materials will be provided.

Alcohol use disorder and strategies to reduce risk

ACTIVE COMPARATOR

The information provided to participants will be related to alcohol use disorder, including a definition, prevalence, consequences, risk factors, and risk-reducing strategies. The content is based on information from National Institute of Alcohol Abuse and Alcoholism websites, Mayo Clinic websites, and the National Survey on Drug Use and Health.

Behavioral: Alcohol use disorder and strategies to reduce risk educational material

Complex polygenic risk scores, alcohol use disorder, and strategies to reduce risk

ACTIVE COMPARATOR

The information provided to participants will explain polygenic risk scores by discussing genetic variation, risk variants, how polygenic scores are created, and how they can be interpreted. The participants will also receive the same information related to alcohol use disorder, including a definition, prevalence, consequences, risk factors, and risk-reducing strategies.

Behavioral: Complex polygenic risk scores, alcohol use disorder, and strategies to reduce risk educational material

Interventions

Participants will be directed to educational information (\~5 minutes) regarding alcohol use disorder and strategies to reduce risk which they will read.

Alcohol use disorder and strategies to reduce risk

Participants will be directed to educational information (\~10 minutes) regarding complex polygenic risk scores, alcohol use disorder and strategies to reduce risk which they will read.

Complex polygenic risk scores, alcohol use disorder, and strategies to reduce risk

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergraduate Virginia Commonwealth University students 18 or older
  • Voluntary consent must be provided

You may not qualify if:

  • Under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (2)

  • Driver MN, Kuo SI, Dron JS, Austin J, Dick DM. The impact of receiving polygenic risk scores for alcohol use disorder on psychological distress, risk perception, and intentions to reduce drinking. Am J Med Genet B Neuropsychiatr Genet. 2023 Jul-Sep;192(5-6):93-101. doi: 10.1002/ajmg.b.32933. Epub 2023 Mar 1.

  • Driver MN, Kuo SI, Petronio L, Brockman D, Dron JS, Austin J, Dick DM. Evaluating the impact of a new educational tool on understanding of polygenic risk scores for alcohol use disorder. Front Psychiatry. 2022 Nov 23;13:1025483. doi: 10.3389/fpsyt.2022.1025483. eCollection 2022.

MeSH Terms

Conditions

AlcoholismGenetic Risk Score

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersGenetic Predisposition to DiseaseDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Danielle Dick, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 19, 2021

First Posted

December 3, 2021

Study Start

November 15, 2021

Primary Completion

December 13, 2021

Study Completion

December 13, 2021

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations