Clinical trial NCT05383989: The UniVenture Program
Official title: UniVenture: A Partnership to Address Heavy Drinking and Other Substance Misuse on Canadian University Campuses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Sensitivity
Hopelessness
Sensation Seeking
Impulsivity
Keywords: Substance misuse
Prevention
Personality
Knowledge mobilization
Well-being
Academic retention
Academic performance
Binge drinking
Emerging adulthood
Life transitions
Technology assisted programs
Student services
Lead sponsor: Dalhousie University
Sponsor class: OTHER
Collaborators: name: Dalhousie University
name: St. Francis Xavier University
name: Université de Montréal
name: York University
name: University of British Columbia
name: University of Victoria
name: Canadian Centre on Substance Use and Addiction (CCSA)
name: Canadian Research Initiative in Substance Misuse
name: Injury Free Nova Scotia (IFNS)
name: Mental Health Commission of Canada (MHCC)
name: Postsecondary Education Partnership - Alcohol Harms (PEP-AH)
name: Strategy for Patient Orientated Research
name: SHARP- Students for Healthy Alternatives & Risk Prevention
name: Nova Scotia Health Authority
First posted: 2022-05-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. A 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)
2. A personality-matched wellness program condition in distance-delivery format (i.e., high AS student receives distance-delivered AS workshop; etc. as per the face-to-face format).
3. Services-as-usual offered by the respective university
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in alcohol-related harms in undergraduates
timeFrame: Past 3 months
measure: Changes in cannabis-related harms in undergraduates
timeFrame: Past 3 months
measure: Changes in the student wellbeing in undergraduates
timeFrame: Past 3 months
Secondary outcomes:
measure: Differences in semester GPA between treatment groups.
timeFrame: Through study completion, an average of 1 year
measure: Changes in scores on the undergraduates' Academic retention measure
timeFrame: Through study completion, an average of 1 year
measure: Changes in scores on the undergraduates' Academic challenges measure
timeFrame: Past 2 weeks
measure: Changes in scores on the undergraduate self-regulated learning (SRL) behaviour measure and Self-efficacy beliefs for undergraduates' success measures
timeFrame: Past 2 weeks
measure: Changes in score of hazardous drinkers in undergraduates
timeFrame: Past 3 months
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia-Okanagan campus
state: British Columbia
city: Antigonish
country: Canada
facility: St. Francis Xavier University
state: Nova Scotia
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
city: Toronto
country: Canada
facility: York University
state: Ontario
city: Montréal
country: Canada
facility: Université de Montréal
state: Quebec
Study officials:
affiliation: Dalhousie University
name: Sherry H Stewart
role: STUDY_DIRECTOR
affiliation: Université de Montréal
name: Patricia Conrod
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Francis Xavier University
name: Kara Thompson
role: PRINCIPAL_INVESTIGATOR
affiliation: York University
name: Matthew T Keough
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia- Okanagan
name: Marvin Krank
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Victoria
name: Allyson Hadwin
role: PRINCIPAL_INVESTIGATOR
References:
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