Novel Prevention Intervention Program to Reduce Risky Patterns of Substance Use Among Emerging Adults (ARFP)

• ClinicalTrials.gov Identifier: NCT06287203
• Recruitment Status: Not yet recruiting
• First Posted: March 1, 2024
• Last Update Posted: March 1, 2024
• Sponsor: Rutgers, The State University of New Jersey
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Danielle Dick, RWJMS, Rutgers, The State University of New Jersey

Study Description

Brief Summary:

The purpose of this research study is to test whether completion of a new personalized feedback program is associated with reductions in risky substance use among emerging adults (18-25 years of age).

Condition or disease	Intervention/treatment	Phase
Substance Use	Behavioral: Addiction Risk Feedback Program	Not Applicable

Detailed Description:

There has been tremendous advances in gene identification. From large-scale, well-powered genome wide association studies (GWAS), polygenic scores (PGS) can now be calculated that sum risk alleles across the genome and weight them by their effect size, creating an index of genetic liability for any given individual. But genetic influences are only part of what contributes to substance use disorders; the environment also plays a critical role. Accordingly, understanding the development of substance use outcomes necessitates integrating both genetic and environmental information. The rationale for this line of research is that the integration of genetic and environmental information will provide the foundation for precision medicine, and that the provision of this personalized risk information will help prevent the development of problems and/or allow for earlier intervention before problems have become severe. Our research team is creating a new prevention/intervention program, consisting of an on-line platform for individuals to receive their personalized risk estimates for addiction risk, created by integrating information about their genetic, behavioral, and environmental risk factors followed by information about how to reduce risk.

The investigators are enrolling a sample of emerging adults (18-25 years of age) into a randomized controlled trial consisting of 4 conditions. All four conditions will involve completion of a behavioral/environmental risk survey and the provision of saliva to determine genetic risk. Three active conditions involve individuals receiving their personalized risk estimates, followed by (condition 1) psychoeducation about ways to reduce substance use and associated harm; (condition 2) the on-line CBT-based module to assist with controlling substance use; or (condition 3) a follow-up appointment with a genetic counselor (GC). The fourth condition will be a waitlist control, in which individuals will receive psychoeducation only at the time that the active conditions receive their personalized risk estimates.

At the first time point (T0), participants will be randomly selected into one of four conditions. Participants have an equal chance of being assigned to any one of the conditions. Across all conditions, the investigators will measure substance use and problems at enrollment (T0), at the time of receipt of risk estimates (~8 weeks later; or at the time other participants receive their results (~8 weeks later) in the case of control condition) (T1), 1 month (T2), and 3 months (T3) after completion of the program.

After the final survey (T3), participants in the control condition will receive their personalized risk estimates. All participants, regardless of their initial group, will be invited to receive access to the content of conditions in which they did not take part (e.g., online modules, appointment with a genetic counselor).

Findings from this study have great potential to enhance our ability to use precision medicine to prevent the development of substance use disorders and/or intervene earlier in the progression to disorder.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: Participants will not be made aware of their condition at baseline; however, they will know their condition once they receives their estimates (or not, in the case of the control condition) and are taken to their follow-up resources.
• Primary Purpose: Prevention
• Official Title: Novel Prevention Intervention Program to Reduce Risky Patterns of Substance Use Among Emerging Adults
• Estimated Study Start Date: March 20, 2024
• Estimated Primary Completion Date: November 20, 2024
• Estimated Study Completion Date: November 20, 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Risk estimates + Psychoeducation; Participants in this condition will complete the prevention program in which individuals receive their personalized risk estimates, followed by psychoeducation about ways to reduce substance use and associated harm.	Behavioral: Addiction Risk Feedback Program; This novel prevention/intervention program will be accessed via an on-line interactive website where individuals receive their personalized risk estimates, based on their genetic, behavioral, and environmental risk factors (part 1 of the program), accompanied by information to help them reduce risk (part 2 of the program). The information in part 2 of the program will vary between arms.
Active Comparator: Risk estimates + Online CBT Modules; Participants in this condition will complete the prevention program in which individuals receive their personalized risk estimates, followed by on-line cognitive behavioral therapy (CBT)-based modules to assist with controlling substance use.	Behavioral: Addiction Risk Feedback Program; This novel prevention/intervention program will be accessed via an on-line interactive website where individuals receive their personalized risk estimates, based on their genetic, behavioral, and environmental risk factors (part 1 of the program), accompanied by information to help them reduce risk (part 2 of the program). The information in part 2 of the program will vary between arms.
Active Comparator: Risk estimates + Genetic Counselor; Participants in this condition will complete the prevention program in which individuals receive their personalized risk estimates, followed by a follow-up appointment with a genetic counselor.	Behavioral: Addiction Risk Feedback Program; This novel prevention/intervention program will be accessed via an on-line interactive website where individuals receive their personalized risk estimates, based on their genetic, behavioral, and environmental risk factors (part 1 of the program), accompanied by information to help them reduce risk (part 2 of the program). The information in part 2 of the program will vary between arms.
Waitlist Control - Psychoeducation Only; Participants in this condition will not receive their personalized risk estimates until the end of the study. They will receive psychoeducation about ways to reduce substance use and associated harm at the time that the active conditions receive their estimates and associated follow-up content.	Behavioral: Addiction Risk Feedback Program; This novel prevention/intervention program will be accessed via an on-line interactive website where individuals receive their personalized risk estimates, based on their genetic, behavioral, and environmental risk factors (part 1 of the program), accompanied by information to help them reduce risk (part 2 of the program). The information in part 2 of the program will vary between arms.

Outcome Measures

Primary Outcome Measures :

1. Alcohol Consumption [ Time Frame: 3 months ]
   Alcohol consumption will be measured using the Alcohol Use Disorders Identification Test (AUDIT) consumption subscale. The AUDIT-C consists of 3 items (e.g., "how often do you have a drink containing alcohol"). Items are rated on a 5-point scale. Items will be summed to create subscale totals with higher scores representing higher levels of that behavior (e.g., higher alcohol consumption. Scores can range from 0 to 12.
2. Alcohol Problems [ Time Frame: 3 months ]
   Alcohol problems will be measured using the AUDIT problems subscale ( Bohn, Babor, & Kranzler, 1995). The AUDIT-P consists of 6 items (e.g., "how often do you have a drink containing alcohol"). Items are rated on a 5-point scale. Items will be summed to create subscale totals with higher scores representing higher levels of that behavior (e.g., higher alcohol problems). Scores can range from 0 to 24.
3. Drug Use Problems [ Time Frame: 3 months ]
   Drug Use problems will be measured using the Drug Use Disorders Identification Test (DUDIT) scale. The DUDIT consists of 11 items (e.g., "how often do you use drugs other than alcohol"). Items are rated on a 5-point scale. Items will be summed to create subscale totals with higher scores representing higher levels of that behavior (e.g., higher drug consumption). Scores can range from 0 to 44.
4. Readiness to change [ Time Frame: 3 months ]
   The Readiness to Change Questionnaire is a 12-item measure that provides scores for three subscales (Precontemplation, Contemplation, and Action) representing stages of change. Items (e.g., "I am trying to drink/ use other drugs less than I used to") are rated on a 5-point scale with response options ranging from "strongly disagree" to "strongly agree." Items will be summed to create three total subscale scores. Based on subscale scores, individuals will be categorized to one of the three categories. We will assess change in the percent of individuals in each category.
5. Future substance use intentions [ Time Frame: 3 months ]
   Future substance use intentions will be assessed with three items: "how often do you plan to drink alcohol next month," "how often do you plan to get drunk next month," and "how often do you plan to use drugs next month" with response options of "less than last month," "the same as last month," and "more than last month." We will assess change in the percent of individuals in each category (less, same, more than last month) for all three items.

Secondary Outcome Measures :

1. Worry About Substance Use Disorders [ Time Frame: Baseline to 3 months ]
   An adapted version of the Cancer Worry Scale will be used to assess worry about developing substance use disorders within the past 30-days. The scale consists of 8 items (e.g., "How often do you worry about developing alcohol or other drug use disorder?") rated on a 4-point scale. Items will be summed to create a total scale score with higher scores reflecting higher levels of worry about substance use disorders.
2. Perceived Susceptibility [ Time Frame: 3 months ]
   Perceived susceptibility of developing alcohol use or other drug use disorder will be assessed using the Health Beliefs about Mental Illness Instrument (Saleeby, 2000). The scale consists of 5-items (e.g., "my chances of having alcohol or other drug problems are great") rated on a 5-point scale with response options ranging from "strongly agree" to "strongly disagree." Items will be summed to create a total scale score with higher scores reflecting higher perceived susceptibility for substance use disorders.
3. Well-Being [ Time Frame: 3 months ]
   Well-being will be assessed with the Mental Health Continuum-Short Form. The scale consists of 14-items which assess aspects of positive mental health (e.g., "I felt happy") over the past 30-days. The items are rated on a 6-point scale with response options ranging from "never" to "every day." Items will be summed to create a total scale score with higher scores reflecting higher levels of positive well-being
4. Anxiety and Depressive Symptoms [ Time Frame: Baseline to 3 months ]
   Abbreviated scales from the Symptom Checklist-90 will be used to assess anxiety and depressive symptoms occurring within the past 30-days. The anxiety (e.g., "nervousness or shakiness inside") and depressive symptoms (e.g., "feeling no interest in things) subscales consist of four items each. Items are rated on a 5-point Likert-type scale with response options ranging from "not at all to "extremely." Items will be summed to create total subscale scores with higher scores reflecting higher levels of anxiety and depressive symptoms.
5. Addiction Risk Program Satisfaction [ Time Frame: immediately after the intervention ]
   Satisfaction with the addiction risk program will be assessed with 12 items after participants receive their personalized risk estimates. Example items include "I learned new information as part of this program," "I enjoyed receiving my personalized risk profile," and "The online delivery method of the information was convenient." The items are rated on a 5-point scale with response options ranging from "strongly agree" to "strongly disagree."This will only be administered to the three active interventions.
6. Feelings About Results [ Time Frame: immediately after the intervention ]
   Feelings about receiving results will be assessed with an adapted version of the Feelings About Genomic Testing Results Questionnaire. 10 items will be used to measure how participants feel about their personalized risk estimates. The items will be rated on a 5-point scale with response options ranging from "not at all" to "a great deal." Items will be summed to create a total scale score, with higher scores reflecting more positive feelings about receiving genetic test results. This will only be administered to the three active interventions.
7. Satisfaction with the Assigned Conditions [ Time Frame: 3 months ]
   Satisfaction with the three conditions (psychoeducation, CBT, and genetic counseling) will be assessed with 10 items. Beyond the name of the condition referred to in each of the items ("education content," "modules," and "genetic counseling", respectively) the satisfaction items are the same for each of the three conditions (e.g., "I learned useful information as part of the modules"). The items are rated on a 5-point scale with response options ranging from "strongly agree" to "strongly disagree." The satisfaction items will be administered to the waitlist control in the T1part 2 survey, and it will be administered to the three active conditions in the T2 and T3 follow-up surveys. If the participant completed the satisfaction items at T2, they will not receive them again at T3.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 25 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• This study is for emerging adults between 18-25 years who reside in the United States. These individuals must also be English-speaking.

Exclusion Criteria:

• Participants will be excluded from the study if they are younger than 18 years old, older than 25 years old, reside outside of the United States, or if they do not provide informed consent. These exclusion criteria have been chosen because we are targeting emerging adults (a particularly risky population in terms of substance use behaviors).

Contacts and Locations

Contacts

Contact: Emily Balcke; 732-235-5607; dnadiscoverystudy@rutgers.edu

Locations

United States, New Jersey

Rutgers Robert Wood Johnson Medical School

Piscataway, New Jersey, United States, 08854

Contact: Emily Balcke dnadiscoverystudy@rutgers.edu

Principal Investigator: Danielle Dick, PhD

Sponsors and Collaborators

Rutgers, The State University of New Jersey

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Danielle Dick, PhD; Rutgers Robert Wood Johnson Medical School

More Information

Publications:

Bohn MJ, Babor TF, Kranzler HR. The Alcohol Use Disorders Identification Test (AUDIT): validation of a screening instrument for use in medical settings. J Stud Alcohol. 1995 Jul;56(4):423-32. doi: 10.15288/jsa.1995.56.423.

Berman AH, Bergman H, Palmstierna T, Schlyter F. Evaluation of the Drug Use Disorders Identification Test (DUDIT) in criminal justice and detoxification settings and in a Swedish population sample. Eur Addict Res. 2005;11(1):22-31. doi: 10.1159/000081413.

Dar-Nimrod I, Zuckerman M, Duberstein PR. The effects of learning about one's own genetic susceptibility to alcoholism: a randomized experiment. Genet Med. 2013 Feb;15(2):132-8. doi: 10.1038/gim.2012.111. Epub 2012 Aug 30. Erratum In: Genet Med. 2013 May;15(5):412.

Derogatis LR, Lipman RS, Covi L. SCL-90: an outpatient psychiatric rating scale--preliminary report. Psychopharmacol Bull. 1973 Jan;9(1):13-28. No abstract available.

Keyes CLM. Brief description of the mental health continuum short form (MHC-SF). 2009. http://www.sociology.emory.edu/ckeyes/

Heather N, Rollnick S, Bell A. Predictive validity of the Readiness to Change Questionnaire. Addiction. 1993 Dec;88(12):1667-77. doi: 10.1111/j.1360-0443.1993.tb02042.x.

Custers JA, van den Berg SW, van Laarhoven HW, Bleiker EM, Gielissen MF, Prins JB. The Cancer Worry Scale: detecting fear of recurrence in breast cancer survivors. Cancer Nurs. 2014 Jan-Feb;37(1):E44-50. doi: 10.1097/NCC.0b013e3182813a17.

Saleeby JR. Health beliefs about mental illness: An instrument development study. American Journal of Health Behavior. 2000;24(2):83-95.

Li M, Bennette CS, Amendola LM, Ragan Hart M, Heagerty P, Comstock B, Tarczy-Hornoch P, Fullerton SM, Regier DA, Burke W, Trinidad SB, Jarvik GP, Veenstra DL, Patrick DL. The Feelings About genomiC Testing Results (FACToR) Questionnaire: Development and Preliminary Validation. J Genet Couns. 2019 Apr;28(2):477-490. doi: 10.1007/s10897-018-0286-9. Epub 2018 Dec 14.

• Responsible Party: Danielle Dick, RWJMS, Professor, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT06287203
• Other Study ID Numbers: Pro2023001498; 3R01DA050721-04S1 ( U.S. NIH Grant/Contract )
• First Posted: March 1, 2024
• Last Update Posted: March 1, 2024
• Last Verified: February 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: We do not plan to make individual participant data (IPD) available to other researchers.

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

Additional relevant MeSH terms:

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders