Alcohol Use DisorderNCT05143073
Understanding Genetic Risk for Alcohol Use Disorder
A study testing Alcohol use disorder and strategies to reduce risk educational material and Complex polygenic risk scores, alcohol use disorder, and strategies to reduce risk educational material in people with Alcohol Use Disorder, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Alcohol use disorder and strategies to reduce risk educational material and Complex polygenic risk scores, alcohol use disorder, and strategies to reduce risk educational material
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 13 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergraduate Virginia Commonwealth University students 18 or older
- Voluntary consent must be provided
Who cannot join
- Under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Alcohol use disorder and strategies to reduce risk educational material, Complex polygenic risk scores, alcohol use disorder, and strategies to reduce risk educational material
- Keywords
- Genetic Feedback, Personalized Risk Information, Alcohol Use Disorder, Educational Intervention, Polygenic Risk Scores, Health Beliefs
- Medical subject headings
- Alcoholism, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol use disorder and strategies to reduce risk educational materialBehavioural
Participants will be directed to educational information (~5 minutes) regarding alcohol use disorder and strategies to reduce risk which they will read.
Complex polygenic risk scores, alcohol use disorder, and strategies to reduce risk educational materialBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Complex polygenic risk scores, alcohol use disorder, and strategies to reduce risk educational material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 hour
Secondary outcomes (7)
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.
Measured: 1 hour
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.
Measured: 1 hour
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).
Measured: 1 hour
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.
Measured: 1 hour
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.
Measured: 1 hour
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).
Measured: 1 hour
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start15 Nov 2021
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle Dick, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143073
- Sponsor's protocol ID
- HM20023103
- Status last verified
- Jan 2022
- First submitted
- 19 Nov 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36856135Driver 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.
PubMed 36506445
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Genetic Risk for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT05143073
- Acronym / sponsor ID
- HM20023103
- Conditions
- Alcohol Use Disorder
- Keywords
- Genetic Feedback, Personalized Risk Information, Alcohol Use Disorder, Educational Intervention, Polygenic Risk Scores, Health Beliefs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No educational materials | No intervention | –No educational materials will be provided. |
| Alcohol use disorder and strategies to reduce risk | Active comparator | Behavioral: Alcohol use disorder and strategies to reduce risk educational materialThe 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. |
| Complex polygenic risk scores, alcohol use disorder, and strategies to reduce risk | Active comparator | Behavioral: Complex polygenic risk scores, alcohol use disorder, and strategies to reduce risk educational materialThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergraduate Virginia Commonwealth University students 18 or older
- Voluntary consent must be provided
Key exclusion criteria (1 listed)
- Under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol use disorder and strategies to reduce risk educational materialParticipants will be directed to educational information (~5 minutes) regarding alcohol use disorder and strategies to reduce risk which they will read. | Behavioural | Alcohol use disorder and strategies to reduce risk |
| Complex polygenic risk scores, alcohol use disorder, and strategies to reduce risk educational materialParticipants 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. | Behavioural | Complex polygenic risk scores, alcohol use disorder, and strategies to reduce risk |
Primary outcome
Understanding of genetic risk scores for alcohol use disorder
Time frame: 1 hour
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
Time frame: 1 hour
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.
7 secondary outcomes
Perceived barriers to risk reducing behavior
Time frame: 1 hour
Perceived severity of alcohol use disorder
Time frame: 1 hour
Genetic knowledge
Time frame: 1 hour
Future intentions
Time frame: 1 hour
Hypothetical psychological impact of receiving a genetic risk score
Time frame: 1 hour
Self-perceived risk of developing alcohol use disorder
Time frame: 1 hour
Worry about developing alcohol use disorder
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Derived from this study: PubMed 36856135Driver 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.
- Derived from this study: PubMed 36506445Driver 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.
- Individual participant dataSharing planned: No
Related trials for Alcohol Use Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Dick, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol use disorder and strategies to reduce risk educational material and Complex polygenic risk scores, alcohol use disorder, and strategies to reduce risk educational material in people with Alcohol Use Disorder, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understanding of genetic risk scores for alcohol use disorder (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05143073, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.