Clinical trial NCT05143073: Understanding Genetic Risk for Alcohol Use Disorder
Official title: Understanding Genetic Risk for Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Genetic Feedback
Personalized Risk Information
Alcohol Use Disorder
Educational Intervention
Polygenic Risk Scores
Health Beliefs
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

• Under the age of 18

Primary outcomes:
measure: Understanding of genetic risk scores for alcohol use disorder
timeFrame: 1 hour
measure: Perceived susceptibility of developing alcohol use disorder
timeFrame: 1 hour
Secondary outcomes:
measure: Perceived barriers to risk reducing behavior
timeFrame: 1 hour
measure: Perceived severity of alcohol use disorder
timeFrame: 1 hour
measure: Genetic knowledge
timeFrame: 1 hour
measure: Future intentions
timeFrame: 1 hour
measure: Hypothetical psychological impact of receiving a genetic risk score
timeFrame: 1 hour
measure: Self-perceived risk of developing alcohol use disorder
timeFrame: 1 hour
measure: Worry about developing alcohol use disorder
timeFrame: 1 hour
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Danielle Dick, PhD
role: PRINCIPAL_INVESTIGATOR
References: