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

NCT06287203 | Completed

• 2 other identifiers: Pro20230014983R01DA050721-04S1
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

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).

Conditions

Substance Use

Outcome Measures

Primary Outcomes (5)

• Alcohol Consumption

  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.

  3 months

• Alcohol Problems

  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 months

• Drug Use Problems

  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.

  3 months

• Readiness to change

  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.

  3 months

• Future substance use intentions

  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.

  3 months

Secondary Outcomes (7)

• Worry About Substance Use Disorders

  Baseline to 3 months

• Perceived Susceptibility

  3 months

• Well-Being

  3 months

• Anxiety and Depressive Symptoms

  Baseline to 3 months

• Addiction Risk Program Satisfaction

  immediately after the intervention

Study Arms (4)

Risk estimates + Psychoeducation

ACTIVE COMPARATOR

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

Risk estimates + Online CBT Modules

ACTIVE COMPARATOR

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

Risk estimates + Genetic Counselor

ACTIVE COMPARATOR

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

Waitlist Control - Psychoeducation Only

OTHER

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

Interventions

Addiction Risk Feedback Program BEHAVIORAL

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; Risk estimates + Online CBT Modules; Risk estimates + Psychoeducation; Waitlist Control - Psychoeducation Only

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Rutgers Robert Wood Johnson Medical School

Piscataway, New Jersey, 08854, United States

Location

Related Publications (9)

• 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.

  PMID: 7674678 BACKGROUND

• 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.

  PMID: 15608468 BACKGROUND

• 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.

  PMID: 22935722 BACKGROUND

• 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.

  PMID: 4682398 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 8130706 BACKGROUND

• 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.

  PMID: 23448956 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 30964586 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Danielle Dick, PhD

  Rutgers Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 1, 2024
• Study Start: April 12, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)