Novel Prevention Intervention Program to Reduce Risky Patterns of Substance Use Among Emerging Adults
NCT ID: NCT06287203
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
660 participants
INTERVENTIONAL
2024-04-12
2026-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
18 Years
25 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Danielle Dick, RWJMS
Professor
Principal Investigators
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Danielle Dick, PhD
Role: PRINCIPAL_INVESTIGATOR
Rutgers Robert Wood Johnson Medical School
Locations
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Rutgers Robert Wood Johnson Medical School
Piscataway, New Jersey, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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Pro2023001498
Identifier Type: -
Identifier Source: org_study_id
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