The UniVenture Program

NCT ID: NCT05383989

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-11
• Study Completion Date: 2024-07-01

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.

Conditions

Anxiety Sensitivity; Hopelessness; Sensation Seeking; Impulsivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

UniVenture- face-to-face (in-person format)

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)

Group Type: EXPERIMENTAL

UniVenture Hopelessness manual

Intervention Type: BEHAVIORAL

Intended for those who score at least 0.5 standard deviation (SD) above the population-specific norm on Hopelessness (HOP) personality traits on the Substance Use Risk Profile Scale (SURPS).

UniVenture Anxiety Sensitivity manual

Intervention Type: BEHAVIORAL

Intended for those who score at least 0.5 standard deviation (SD) above the population-specific norm on Anxiety Sensitivity (AS) personality traits on the Substance Use Risk Profile Scale (SURPS).

UniVenture Sensation Seeking manual

Intervention Type: BEHAVIORAL

Intended for those who score at least 0.5 standard deviation (SD) above the population-specific norm on Sensation Seeking (SS) personality traits on the Substance Use Risk Profile Scale (SURPS)

UniVenture Impulsivity manual

Intervention Type: BEHAVIORAL

Intended for those who score at least 0.5 standard deviation (SD) above the population-specific norm on Impulsivity (IMP) personality traits on the Substance Use Risk Profile Scale (SURPS).

UniVenture- online (distance-delivery format)

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

Group Type: ACTIVE_COMPARATOR

UniVenture Hopelessness manual

Intervention Type: BEHAVIORAL

Intended for those who score at least 0.5 standard deviation (SD) above the population-specific norm on Hopelessness (HOP) personality traits on the Substance Use Risk Profile Scale (SURPS).

UniVenture Anxiety Sensitivity manual

Intervention Type: BEHAVIORAL

Intended for those who score at least 0.5 standard deviation (SD) above the population-specific norm on Anxiety Sensitivity (AS) personality traits on the Substance Use Risk Profile Scale (SURPS).

UniVenture Sensation Seeking manual

Intervention Type: BEHAVIORAL

Intended for those who score at least 0.5 standard deviation (SD) above the population-specific norm on Sensation Seeking (SS) personality traits on the Substance Use Risk Profile Scale (SURPS)

UniVenture Impulsivity manual

Intervention Type: BEHAVIORAL

Intended for those who score at least 0.5 standard deviation (SD) above the population-specific norm on Impulsivity (IMP) personality traits on the Substance Use Risk Profile Scale (SURPS).

UniVenture- service as usual (control)

Services-as-usual offered by the respective university

Group Type: PLACEBO_COMPARATOR

Service as usual provided by the University

Intervention Type: BEHAVIORAL

It is the regular university-provided well-being services.

Interventions

UniVenture Hopelessness manual

Intended for those who score at least 0.5 standard deviation (SD) above the population-specific norm on Hopelessness (HOP) personality traits on the Substance Use Risk Profile Scale (SURPS).

Intervention Type: BEHAVIORAL

UniVenture Anxiety Sensitivity manual

Intended for those who score at least 0.5 standard deviation (SD) above the population-specific norm on Anxiety Sensitivity (AS) personality traits on the Substance Use Risk Profile Scale (SURPS).

Intervention Type: BEHAVIORAL

UniVenture Sensation Seeking manual

Intended for those who score at least 0.5 standard deviation (SD) above the population-specific norm on Sensation Seeking (SS) personality traits on the Substance Use Risk Profile Scale (SURPS)

Intervention Type: BEHAVIORAL

UniVenture Impulsivity manual

Intended for those who score at least 0.5 standard deviation (SD) above the population-specific norm on Impulsivity (IMP) personality traits on the Substance Use Risk Profile Scale (SURPS).

Intervention Type: BEHAVIORAL

Service as usual provided by the University

It is the regular university-provided well-being services.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dalhousie University

OTHER

Sponsor Role: collaborator

St. Francis Xavier University

UNKNOWN

Sponsor Role: collaborator

Université de Montréal

OTHER

Sponsor Role: collaborator

York University

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

University of Victoria

OTHER

Sponsor Role: collaborator

Canadian Centre on Substance Use and Addiction (CCSA)

UNKNOWN

Sponsor Role: collaborator

Canadian Research Initiative in Substance Misuse

OTHER

Sponsor Role: collaborator

Injury Free Nova Scotia (IFNS)

UNKNOWN

Sponsor Role: collaborator

Mental Health Commission of Canada (MHCC)

UNKNOWN

Sponsor Role: collaborator

Postsecondary Education Partnership - Alcohol Harms (PEP-AH)

UNKNOWN

Sponsor Role: collaborator

Strategy for Patient Orientated Research

UNKNOWN

Sponsor Role: collaborator

SHARP- Students for Healthy Alternatives & Risk Prevention

UNKNOWN

Sponsor Role: collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role: collaborator

Sherry Stewart

OTHER

Sponsor Role: lead

Responsible Party

Sherry Stewart

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sherry H Stewart

Role: STUDY_DIRECTOR

Dalhousie University

Patricia Conrod

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Kara Thompson

Role: PRINCIPAL_INVESTIGATOR

St. Francis Xavier University

Matthew T Keough

Role: PRINCIPAL_INVESTIGATOR

York University

Marvin Krank

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia- Okanagan

Allyson Hadwin

Role: PRINCIPAL_INVESTIGATOR

University of Victoria

Locations

University of British Columbia-Okanagan campus

Kelowna, British Columbia, Canada

Site Status: RECRUITING

St. Francis Xavier University

Antigonish, Nova Scotia, Canada

Site Status: RECRUITING

Dalhousie University

Halifax, Nova Scotia, Canada

Site Status: RECRUITING

York University

Toronto, Ontario, Canada

Site Status: RECRUITING

Université de Montréal

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Fakir Md Yunus

Role: CONTACT

fakir.yunus@dal.ca

306-514-0055

Jennifer E Swansburg

Role: CONTACT

jennifer.swansburg@dal.ca

902-494-3793

Facility Contacts

Cassidy RD Wallis, MA

Role: primary

cassidywallis13@gmail.com

Katherine Rose, MA

Role: backup

katherine.rose@ubc.ca

Stephanie Cooper

Role: primary

scooper@stfx.ca

Fakir Md Yunus, PhD

Role: primary

fakir.yunus@dal.ca

306-514-0055

Jennifer E Swansburg

Role: backup

jennifer.swansburg@dal.ca

902-494-3793

Matthew Keough, PhD

Role: primary

keoughmt@yorku.ca

Patricia Conrod, PhD

Role: primary

Patricia.conrod@umontreal.ca

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 28252892 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 17007600 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 18211277 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

2021-5689

Identifier Type: -

Identifier Source: org_study_id