Novel Prevention Intervention Program to Reduce Risky Patterns of Substance Use Among Emerging Adults
Purpose
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
- Substance Use
Eligibility
- Eligible Ages
- Between 18 Years and 25 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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).
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
|
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. |
|
|
Other 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. |
|
Recruiting Locations
Piscataway, New Jersey 08854
More Details
- NCT ID
- NCT06287203
- Status
- Recruiting
- Sponsor
- Rutgers, The State University of New Jersey
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.