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The UniVenture Program

S

Sherry Stewart

Status

Enrolling

Conditions

Hopelessness
Anxiety Sensitivity
Impulsivity
Sensation Seeking

Treatments

Behavioral: Service as usual provided by the University
Behavioral: UniVenture Impulsivity manual
Behavioral: UniVenture Anxiety Sensitivity manual
Behavioral: UniVenture Sensation Seeking manual
Behavioral: UniVenture Hopelessness manual

Study type

Interventional

Funder types

Other

Identifiers

NCT05383989
2021-5689

Details and patient eligibility

About

UniVenture is a research partnership with one common goal: to adapt, test, and begin sharing an effective, sustainable, targeted wellness program to tackle the timely social issue of heavy drinking and other substance misuse on Canadian campuses. Our project is a 5-year, multi-site, controlled study involving 1st and 2nd year undergraduates at 5 representatively diverse Canadian university sites (Dalhousie University, St. Francis Xavier University, York University, Université de Montréal, and University of British Columbia-Okanagan). The investigator will test a program targeting personality traits linked to substance misuse. An earlier version of this program led to marked reductions in substance use and distress in adolescents. Our novel objectives are to examine the program's effects on substance use and distress among emerging adults; uptake of prescription drug use given the opioid crisis; and undergraduates' academic success. The investigator will carry out a randomized controlled trail in which two versions of the program will be assessed: a face-to-face and an innovative and accessible technology-assisted distance-delivery format, both compared to normal campus services alone. UniVenture may potentially have a dramatic effect on university policies on the prevention of substance misuse on Canadian campuses by helping partners appreciate the effectiveness of targeted and personalized approaches, and leveraging partners' expansive networks to inform other Canadian universities. A successful technology-assisted distance-delivered program will provide universities with an effective, relatively low-cost, and accessible tool to intervene with risky substance use behaviors in undergraduates. A successful program for at-risk students will also profoundly impact their academic performance and goal achievement, as well as their lives beyond university. Our partnership will impact knowledge sharing and student training opportunities. With a diversity of academic and non-academic partners and an integrative knowledge sharing approach, the investigator will share results with many audiences throughout the project. The academic researchers have recognized expertise in training and mentoring students. Further, trainees will be exposed to many opportunities and settings both inside and outside of the university in which to apply their research skills to substance misuse prevention.

Full description

The UniVenture program is a wellness program designed for university students, to be tested at 5 university-based sites (Dalhousie University, St. Francis Xavier University, York University, Université de Montréal, and University of British Columbia-Okanagan), and based on an existing, successful, and internationally recognized and -utilized program called PreVenture (designed for high school students). PreVenture is a selective personality-targeted approach based on an etiologic model of substance misuse behaviors, outlined and validated by Drs. Stewart (Project Director [PD]) and Conrod (Co-Applicant [CA]). PreVenture targets personality-specific motivational pathways to substance misuse, AS, HOP, SS, and IMP, each associated with different motives for substance use, substance use profiles, and patterns of emotional distress and risk-taking. Well-controlled studies show PreVenture reduces or delays teens' binge drinking, illicit drug use, and associated emotional problems by 30-80% with effects lasting at least 2 years. While PreVenture: (a) was designed for and is effective for high school students, its efficacy in university students is untested; (b) is effective for alcohol and cannabis use, its effects on prescription drug misuse are unknown; and (c) works to reduce student distress, it is untested for preventing academic struggles and university drop out. These latter academic outcomes are of major concern to our Student Affairs partners given the current shockingly high university drop-out rates (18.7-36.9%) and strong ties of student substance misuse and distress with poorer academic outcomes. The purpose of the UniVenture study is to measure the efficacy the developmentally adapted program has on primary outcomes of (1) Reduction of alcohol-related harms in undergraduates (2) Reduction of cannabis-related harms in undergraduates (3) Changes in the student wellbeing in undergraduates. Secondary outcomes are (1) Differences in semester GPA between treatment groups. (2) Changes in scores on the undergraduates' Academic retention measure (3) Changes in scores on the undergraduates' Academic challenges measure (4) Changes in scores on the undergraduate self-regulated learning (SRL) behaviour measure and Self-efficacy beliefs for undergraduates' success measures (5) Reduction in score of hazardous drinkers in undergraduates.

Barriers to accessing evidence-based programs contribute to the ineffectiveness of campus-based substance misuse prevention. These barriers include students' time commitments, lack of available services, fear of stigma, and long wait lists which may discourage students from seeking or engaging in existing programs, leading to more severe problems before participants receive help. A distance-delivery approach involves using remote communication technologies (e.g., web-based, email, chat) to link students with a facilitator in place of face-to-face meetings. This may improve access for those with difficulties getting to services or increase confidentiality through engagement from a private location. The investigator proposes a novel randomized controlled study to test the relative effects of our personality-targeted wellness program on hazardous drinking, cannabis use, and uptake of prescription drug misuse among high-personality-risk 1st and 2nd year undergraduates and delivered in 2 formats: traditional face-to-face vs. an innovative and more accessible technology-assisted distance-delivery by well-trained and supervised program facilitators. These two active program conditions will be compared to a services-as-usual only control condition to evaluate how this program compares to what Student Affairs unit partners already do. Withholding the program from at-risk undergraduates randomized to the services-as-usual only control group might be seen as problematic; however, the program's efficacy is untested at the emerging adulthood (EA) developmental stage and in the university context. If the distance-delivered program is shown effective, control condition participants will be sent a free link to the relevant personality-matched web-based materials after the 12-month follow-up.

Enrollment

1,000 estimated patients

Sex

All

Ages

18 to 25 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 1st and 2nd year undergraduate students (either part-time or full-time enrollment)
  • Age between 18- 25 years
  • Have used alcohol and/or cannabis and/or any other substance in the past 3 months,
  • Score at least 0.5 standard deviation (SD) above the population-specific norm on 1 of 4 personality traits on the Substance Use Risk Profile Scale (SURPS) (i) Anxiety Sensitivity (AS) (ii) Hopelessness (HOP) (iii) Sensation Seeking (SS) and (iv) Impulsive (IMP)

Exclusion criteria

• Unwilling to participate

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,000 participants in 3 patient groups, including a placebo group

UniVenture- face-to-face (in-person format)
Experimental group
Description:
Personality-matched wellness program condition in face-to-face format (i.e., high AS student receives face-to-face AS program; high HOP student receives face-to-face HOP workshop: high SS student receives face-to-face SS workshop; high IMP student receives face-to-face IMP workshop)
Treatment:
Behavioral: UniVenture Sensation Seeking manual
Behavioral: UniVenture Anxiety Sensitivity manual
Behavioral: UniVenture Impulsivity manual
Behavioral: UniVenture Hopelessness manual
UniVenture- online (distance-delivery format)
Active Comparator group
Description:
Personality-matched wellness program condition in distance-delivery format (i.e., high AS student receives online (distance-delivered) AS workshop; high HOP student receives online (distance-delivered) HOP workshop: high SS student receives online (distance-delivered) SS workshop; high IMP student receives online (distance-delivered) IMP workshop
Treatment:
Behavioral: UniVenture Sensation Seeking manual
Behavioral: UniVenture Anxiety Sensitivity manual
Behavioral: UniVenture Impulsivity manual
Behavioral: UniVenture Hopelessness manual
UniVenture- service as usual (control)
Placebo Comparator group
Description:
Services-as-usual offered by the respective university
Treatment:
Behavioral: Service as usual provided by the University

Trial contacts and locations

5

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Central trial contact

Fakir Md Yunus; Jennifer E Swansburg

Data sourced from clinicaltrials.gov

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