search
Back to results

Understanding Genetic Risk for Alcohol Use Disorder

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol use disorder and strategies to reduce risk educational material
Complex polygenic risk scores, alcohol use disorder, and strategies to reduce risk educational material
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Use Disorder focused on measuring Genetic Feedback, Personalized Risk Information, Alcohol Use Disorder, Educational Intervention, Polygenic Risk Scores, Health Beliefs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

• Under the age of 18

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

No educational materials

Alcohol use disorder and strategies to reduce risk

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

Arm Description

No educational materials will be provided.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Perceived barriers to risk reducing behavior
Perceived barriers to risk reducing behavior assesses perceived barriers to taking risk reducing actions which may include time, acceptability, and cost. This will be measured using the Health Beliefs about Mental Illness Instrument. 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.
Perceived severity of alcohol use disorder
Perceived severity of alcohol use disorder will assess beliefs about the severity of having alcohol problems on an individual's life. Perceived severity will be measured using the Health Beliefs about Mental Illness Instrument. Seven 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.
Genetic knowledge
Genetic knowledge related to psychiatric and substance use disorders will be assessed with an adapted version of the Public Understanding and Attitudes towards Genetics and Genomics Questionnaire (PUGGS). The PUGGS is an 11 item questionnaire which asks about the role of genetic and environmental risk factors in the development of substance use and psychiatric conditions. The number of correct answers is summed to yield a score ranging from 0 (very little understanding of genetic concepts related to psychiatric conditions) to 11 (high understanding of genetic concepts related to psychiatric conditions).
Future intentions
Future intentions will assess whether the individual would seek additional information about alcohol use disorder, discuss risk with healthcare providers, believe it would be important to change drinking behavior, and intend to change drinking behaviors after receiving each hypothetical genetic risk score for alcohol use disorder. The response options for these items include yes, no, and unsure.
Hypothetical psychological impact of receiving a genetic risk score
The hypothetical psychological impact of receiving a genetic risk score will be measured using an adapted version of the Impact of Event Scale. The adapted measure includes 10 items with responses scored from 1 (not at all) to 5 (extremely) which will be averaged to create an overall score. These items will be assessed in each hypothetical genetic risk scenario.
Self-perceived risk of developing alcohol use disorder
Self-perceived risk of developing alcohol use disorder will be measured using an adapted item from Lipkus et al. 2015, a measure originally developed to assess perceived risk of nicotine addiction as a consequence of cigarette smoking. The item will be included immediately after the educational intervention and after each hypothetical genetic risk score. The self-perception of risk item adapted from Lipkus et al. 2015 will be coded as a semi-continuous variable from 1 (no chance) to 7 (certain to happen).
Worry about developing alcohol use disorder
Worry about developing alcohol use disorder will be measured using an adapted version of the Cancer Worry Scale. Eight items from the adapted version of the Cancer Worry Scale will be scored from 1 to 4 and averaged together to create an overall score.

Full Information

First Posted
November 19, 2021
Last Updated
January 18, 2022
Sponsor
Virginia Commonwealth University
search

1. Study Identification

Unique Protocol Identification Number
NCT05143073
Brief Title
Understanding Genetic Risk for Alcohol Use Disorder
Official Title
Understanding Genetic Risk for Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
December 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
The purpose of this study is to conduct a randomized controlled trial to (1) evaluate the impact of receiving educational information about polygenic risk scores on an individual's ability to understand polygenic risk scores for alcohol use disorder, (2) assess the impact of receiving educational information about alcohol use disorder on components of behavior change theories including perceived severity of having alcohol problems, perceived benefits of taking actions to reduce risk for developing alcohol problems, and perceived barriers to taking risk reducing actions, and (3) assess how (hypothetical) genetic risk scores impact an individual's perceived chance of developing alcohol use disorder, future intentions, and an individual's psychological state. The study aims to recruit 300 emerging adults from an urban, public university that will either be assigned to the control condition or one of two intervention groups. Participants in the intervention groups will either receive information about alcohol use disorder and ways to reduce risk or information about polygenic risk scores, alcohol use disorder, and ways to reduce risk. Emerging adults are the focus of this research proposal because they are entering a high-risk age range for the onset of many psychiatric conditions. Additionally, youth and young adults are high consumers of new technologies, with a majority using various digital technologies to access health information. Therefore, emerging adults may be more likely to access their genetic risk information as well as more likely to benefit from receiving genotypic information for alcohol use disorder, uniquely positioning emerging adults as the target population for this study. Additionally, hypothetical genetic risk scores are provided to participants via three scenarios. Participants are asked to imagine they received each genetic risk score (low, average, high) and respond to a series of questions. The hypothetical genetic risk scores are provided using a graph based on the display of polygenic risk scores in the educational information. Low risk will be indicated using a graph in which the genetic risk score is in the 30th percentile, average risk will be indicated using a graph in which the genetic risk score is in the 50th percentile, and high risk will be indicated using a graph in which the genetic risk score is in the 75th percentile. Outcomes from this research study are expected to contribute to our knowledge about how to provide genetic risk information for alcohol use disorder in a way to promote behavior change. The knowledge gained from the research will be critical to provide effective communication of genetic feedback for alcohol use disorder in the future in order to ensure results are delivered in a way that is beneficial to the individual, as well as inform policies and best practices regarding the return of personalized genetic feedback for alcohol use disorder and related psychiatric outcomes. Future research can build upon this knowledge by investigating the acute and long-term impact of returning actual genetic risk information for alcohol use disorder, which will further advance our understanding of the issues surrounding the return of complex genetic feedback.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
Genetic Feedback, Personalized Risk Information, Alcohol Use Disorder, Educational Intervention, Polygenic Risk Scores, Health Beliefs

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
338 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No educational materials
Arm Type
No Intervention
Arm Description
No educational materials will be provided.
Arm Title
Alcohol use disorder and strategies to reduce risk
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Complex polygenic risk scores, alcohol use disorder, and strategies to reduce risk
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Alcohol use disorder and strategies to reduce risk educational material
Intervention Description
Participants will be directed to educational information (~5 minutes) regarding alcohol use disorder and strategies to reduce risk which they will read.
Intervention Type
Behavioral
Intervention Name(s)
Complex polygenic risk scores, alcohol use disorder, and strategies to reduce risk educational material
Intervention Description
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.
Primary Outcome Measure Information:
Title
Understanding of genetic risk scores for alcohol use disorder
Description
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.
Time Frame
1 hour
Title
Perceived susceptibility of developing alcohol use disorder
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Perceived barriers to risk reducing behavior
Description
Perceived barriers to risk reducing behavior assesses perceived barriers to taking risk reducing actions which may include time, acceptability, and cost. This will be measured using the Health Beliefs about Mental Illness Instrument. 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.
Time Frame
1 hour
Title
Perceived severity of alcohol use disorder
Description
Perceived severity of alcohol use disorder will assess beliefs about the severity of having alcohol problems on an individual's life. Perceived severity will be measured using the Health Beliefs about Mental Illness Instrument. Seven 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.
Time Frame
1 hour
Title
Genetic knowledge
Description
Genetic knowledge related to psychiatric and substance use disorders will be assessed with an adapted version of the Public Understanding and Attitudes towards Genetics and Genomics Questionnaire (PUGGS). The PUGGS is an 11 item questionnaire which asks about the role of genetic and environmental risk factors in the development of substance use and psychiatric conditions. The number of correct answers is summed to yield a score ranging from 0 (very little understanding of genetic concepts related to psychiatric conditions) to 11 (high understanding of genetic concepts related to psychiatric conditions).
Time Frame
1 hour
Title
Future intentions
Description
Future intentions will assess whether the individual would seek additional information about alcohol use disorder, discuss risk with healthcare providers, believe it would be important to change drinking behavior, and intend to change drinking behaviors after receiving each hypothetical genetic risk score for alcohol use disorder. The response options for these items include yes, no, and unsure.
Time Frame
1 hour
Title
Hypothetical psychological impact of receiving a genetic risk score
Description
The hypothetical psychological impact of receiving a genetic risk score will be measured using an adapted version of the Impact of Event Scale. The adapted measure includes 10 items with responses scored from 1 (not at all) to 5 (extremely) which will be averaged to create an overall score. These items will be assessed in each hypothetical genetic risk scenario.
Time Frame
1 hour
Title
Self-perceived risk of developing alcohol use disorder
Description
Self-perceived risk of developing alcohol use disorder will be measured using an adapted item from Lipkus et al. 2015, a measure originally developed to assess perceived risk of nicotine addiction as a consequence of cigarette smoking. The item will be included immediately after the educational intervention and after each hypothetical genetic risk score. The self-perception of risk item adapted from Lipkus et al. 2015 will be coded as a semi-continuous variable from 1 (no chance) to 7 (certain to happen).
Time Frame
1 hour
Title
Worry about developing alcohol use disorder
Description
Worry about developing alcohol use disorder will be measured using an adapted version of the Cancer Worry Scale. Eight items from the adapted version of the Cancer Worry Scale will be scored from 1 to 4 and averaged together to create an overall score.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Undergraduate Virginia Commonwealth University students 18 or older Voluntary consent must be provided Exclusion Criteria: • Under the age of 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Dick, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Understanding Genetic Risk for Alcohol Use Disorder

We'll reach out to this number within 24 hrs