Addiction Risk Feedback Program for Substance Abuse

(ARFP Trial)

Overseen By Emily Balcke

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Under 18, Over 25, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program designed to reduce risky substance use among young adults. It examines how personalized feedback can help individuals understand their addiction risk and take steps to manage it. Participants will be divided into groups, with some receiving genetic counseling, psychoeducation (learning about substance use impacts), or online cognitive behavioral therapy (CBT) modules. Individuals aged 18-25 who have experienced substance use issues and reside in the U.S. might find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could shape future substance use interventions.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Addiction Risk Feedback Program is safe for emerging adults?

Research has shown that programs like the Addiction Risk Feedback Program are generally safe for participants. Studies have used these programs to help reduce issues like gambling or drinking without causing harm. Participants have reported satisfaction with receiving personalized risk information, indicating that the process is well-received.

No reports of serious side effects or risks have been linked to these programs. They primarily provide information and education, which typically do not involve physical risks. Based on this, the Addiction Risk Feedback Program appears to be a safe choice for those considering participation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Addiction Risk Feedback Program because it offers a personalized approach to preventing substance abuse. Unlike standard treatments like detox programs, behavioral therapy, and medication-assisted therapy, this program gives participants personalized risk estimates for addiction. This personalized information is then followed by tailored interventions, such as sessions with a genetic counselor, psychoeducation, or online cognitive behavioral therapy (CBT) modules. This individualized strategy aims to empower participants with knowledge of their own risk factors, potentially leading to more effective prevention or reduction of substance use.

What evidence suggests that this trial's treatments could be effective for reducing risky substance use?

Research shows that personalized feedback programs can help reduce risky substance use. Studies have found that people who received personalized feedback reported fewer days of drinking and using other substances. One review found that these programs helped people see how their behaviors compared to others, encouraging safer choices. Another study noted that feedback-based programs could lessen the severity of addiction symptoms. In this trial, participants will receive personalized risk estimates as part of the Addiction Risk Feedback Program. This program includes various follow-up interventions, such as sessions with a genetic counselor, psychoeducation, or online CBT modules, and could help young adults reduce their substance use. ^{1 2 6 7 8}

Who Is on the Research Team?

Danielle Dick, PhD

Principal Investigator

Rutgers Robert Wood Johnson Medical School

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-25 living in the U.S. who speak English and are willing to give informed consent. It's not open to those outside this age range, non-U.S. residents, or anyone unwilling to agree formally to participate.

Exclusion Criteria

Participants residing outside of the United States

Participants who do not provide informed consent

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline Assessment

Participants complete a behavioral/environmental risk survey and provide saliva samples for genetic risk assessment

1 week

1 visit (in-person or virtual)

Intervention

Participants receive personalized risk estimates and engage in one of the intervention conditions: psychoeducation, online CBT modules, or genetic counseling

8 weeks

1 visit (in-person or virtual) for risk estimate delivery

Follow-up

Participants are monitored for changes in substance use and related outcomes

3 months

3 visits (virtual) at 1 month and 3 months post-intervention

Post-Study Access

Participants in the control condition receive their personalized risk estimates and all participants are offered access to other intervention contents

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Addiction Risk Feedback Program

Trial Overview The study is examining a new personalized feedback program designed to help reduce risky substance use among emerging adults. Participants will complete this intervention program aimed at lowering their chances of developing substance use disorders.

How Is the Trial Designed?

Group I: Waitlist Control - Psychoeducation Only Experimental Treatment 1 Intervention

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.

Group II: Risk estimates + Genetic Counselor Active Control 1 Intervention

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.

Group III: Risk estimates + Psychoeducation Active Control 1 Intervention

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.

Group IV: Risk estimates + Online CBT Modules Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The study introduces an online Personalized Feedback Program (PFP) aimed at college students, focusing on their genetically influenced risk factors for substance use rather than just their current usage, which could enhance prevention efforts.

Using data from over 12,000 students, the program identifies key risk factors like Sensation Seeking and Impulsivity, and aims to provide tailored recommendations to help students better manage their substance use risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetically influenced externalizing and internalizing risk pathways as novel prevention targets. Dick, DM., Saunders, T., Balcke, E., et al.[2023]

This project aims to involve substance misuse patients in their treatment by using patient-generated outcome measures (PGOMs), which allow patients to suggest topics for evaluating their treatment, potentially leading to more personalized care.

The research will assess the reliability and sensitivity of PGOMs compared to standard measures, with the expectation that PGOMs will provide valuable insights into patients' personal concerns and motivations, ultimately enhancing treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the patient involvement in outcomes: a study protocol of personalised outcome measurement in the treatment of substance misuse. Alves, PC., Sales, CM., Ashworth, M.[2021]

Systematic client feedback, such as the Partners for Change Outcome Management System (PCOMS), can improve psychotherapy outcomes by addressing issues like client dropouts and varying therapist effectiveness, as supported by randomized clinical trials.

PCOMS not only provides psychometric measures but also emphasizes the importance of client perspectives in therapy, potentially shifting the focus from a purely medical model to a more relational and scientific approach in psychotherapy practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Partners for Change Outcome Management System (PCOMS) revisiting the client's frame of reference. Duncan, BL., Reese, RJ.[2019]

A study involving 5476 Brazilian college students found that the components of personalized normative feedback (PNF) did not significantly reduce alcohol use or its consequences compared to the full intervention, with some evidence suggesting adverse effects, particularly among less motivated participants.

The normative feedback only (NFO) and consequences feedback only (CFO) components showed some short-term benefits in reducing alcohol use and frequency, but they also led to an increase in the number of typical drinks consumed over time, indicating a complex relationship between feedback and drinking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Components evaluation of a web-based personalized normative feedback intervention for alcohol use among college students: a pragmatic randomized controlled trial with a dismantling design. Bedendo, A., McCambridge, J., Gaume, J., et al.[2021]

Personalized drinking feedback interventions (PFIs) are effective in reducing harmful alcohol misuse among college students, based on a comprehensive review of 41 studies.

Interventions that included components like decisional balance, practical costs, and risk-limiting strategies showed significantly larger effects, highlighting the importance of these elements in developing effective feedback-based interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized feedback interventions for college alcohol misuse: an update of Walters & Neighbors (2005). Miller, MB., Leffingwell, T., Claborn, K., et al.[2022]

Individuals who consume higher amounts of alcohol are more likely to choose to receive personalized feedback about their drinking habits, with 85% of participants consistently opting in across two time points.

Receiving feedback led to a small reduction in peak alcohol consumption among heavy drinkers over a 30-day period, suggesting that personalized interventions may help reduce drinking intensity, although further research is needed to confirm these findings in more diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who Opts In to Alcohol Feedback and How Does That Impact Behavior? A Pilot Trial. Boness, CL., Helle, AC., Miller, MB., et al.[2023]

This systematic review analyzed 10 studies on the impact of routine outcome monitoring (ROM) feedback in alcohol and other drug (AOD) treatment, finding that while feedback may improve treatment retention and other outcomes, only one study showed significant reductions in substance use among clients who were not progressing well.

The review highlights the need for more robust randomized trials to better understand the efficacy of feedback in AOD treatment, as the current studies varied widely in methods and outcomes, limiting definitive conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on the effect of routine outcome monitoring and feedback on client outcomes in alcohol and other drug treatment. Cordony, I., Mills, L., Mammen, K., et al.[2023]

An online Personalized Feedback Program (PFP) was developed for college students to address genetically-influenced risk factors for substance use, and 81% of participants reported enjoying the program.

After completing the PFP, 39% of students who drank intended to reduce their alcohol consumption, and 41% intended to decrease their frequency of getting drunk, indicating a higher intention to change compared to previous studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Results from a New College Substance Use Prevention Program Targeting Externalizing and Internalizing Traits. Choi, M., Driver, MN., Balcke, E., et al.[2023]

In a study involving 121 participants from a community substance use disorder clinic, personalized feedback interventions did not show any significant benefits in reducing alcohol consumption compared to standard pre-treatment assessment procedures.

The results indicated that feedback-based brief interventions were ineffective in improving outcomes such as drinking frequency, intensity, or motivation for treatment among individuals with substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Feedback-Based Brief Intervention to Reduce Alcohol Use in Community Substance Use Disorders. Worden, BL., McCrady, BS.[2021]

In a study involving 118 clinicians across 20 outpatient substance abuse treatment clinics, a semiautomated patient feedback system was tested over 12 weeks, but it did not show any significant impact on reducing drug and alcohol use among over 1,500 patients.

The intervention also failed to improve secondary outcomes related to therapeutic alliance and clinician job satisfaction, suggesting that the feedback system may need alternative approaches to enhance clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled study of a web-based performance improvement system for substance abuse treatment providers. Crits-Christoph, P., Ring-Kurtz, S., McClure, B., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3686515/

Effectiveness of a Feedback-Based Brief Intervention to ... Primary outcome variables came from the Addiction Severity Index (ASI; McLellan et al., 1992), a semi-structured interview. The number of drinking days in the ...

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0248262

A systematic review and meta-analysis | PLOS One Substance Abuse. 2019:1–9. 32. Miller MB, DiBello AM, Carey KB ... The efficacy of a personalized feedback-only intervention for at-risk college ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/dar.13848

Effectiveness of web‐based personalised feedback ... PNFs are increasing in the field of addiction [11], however, PFIs that include more topics are also effective [12] and usually cover contents ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749379708009689

Curbing Problem Drinking with Personalized-Feedback ... Description of the Primary Analyzed Studies. The combined literature search generated 406 abstracts and yielded 14 studies (Boon B, Institute for Addiction ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8016245/

The efficacy of Personalized Normative Feedback ... ... substance-related and addictive disorders we focus on in the current review. ... Drug abuse disorders and drug addiction is a serious world health ...

6. karger.com karger.com/cxp/article/11/1/113/933123/Development-of-the-Comprehensive-Addiction-Risk

Development of the Comprehensive Addiction Risk ... Here, we describe the development of the program and initial results on satisfaction and response to receiving personalized addiction risk information from the ...

7. ajpmonline.org ajpmonline.org/article/S0749-3797(08)00968-9/fulltext

Curbing Problem Drinking with Personalized-Feedback ... The effectiveness of personalized-feedback interventions to reduce problem drinking has been evaluated in several RCTs and systematic reviews.

8. researchgate.net researchgate.net/publication/350572743_The_efficacy_of_Personalized_Normative_Feedback_interventions_across_addictions_A_systematic_review_and_meta-analysis

(PDF) The efficacy of Personalized Normative Feedback ... PNF with additional interventions reduced short-term gambling symptom severity. Effect sizes were small. PNF did not alter illicit drug use.