Understanding Genetic Risk for Alcohol Use Disorder

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Alcohol Use Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05143073

HM20023103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 338 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Under the age of 18

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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338 participants in 3 patient groups

No educational materials

No Intervention group

Description:

No educational materials will be provided.

Alcohol use disorder and strategies to reduce risk

Active Comparator group

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.

Treatment:

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 group

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.

Treatment:

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