Anxiety SensitivityNCT05383989
The UniVenture Program
A study testing UniVenture Hopelessness manual, UniVenture Anxiety Sensitivity manual and UniVenture Sensation Seeking manual in people with Anxiety Sensitivity and Hopelessness, run by Sherry Stewart at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Sensitivity, Hopelessness, Sensation Seeking
- What is being tested?
- UniVenture Hopelessness manual, UniVenture Anxiety Sensitivity manual and UniVenture Sensation Seeking manual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 5 sitesCanada
- Study dates
- 11 Sep 2021to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Unwilling to participate
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
St. Francis Xavier University
Antigonish Nova Scotia, Nova Scotia
Stephanie Cooper, scooper@stfx.ca
- Recruiting
Dalhousie University
Halifax, Nova Scotia
Fakir Md Yunus, PhD, 306-514-0055, fakir.yunus@dal.ca
Jennifer E Swansburg, 902-494-3793, jennifer.swansburg@dal.ca
- Recruiting
University of British Columbia-Okanagan campus
Kelowna, British Columbia
Cassidy RD Wallis, MA, cassidywallis13@gmail.com
Katherine Rose, MA, katherine.rose@ubc.ca
- Recruiting
Université de Montréal
Montreal, Quebec
Patricia Conrod, PhD, Patricia.conrod@umontreal.ca
Natalie Castellanos-Ryan, PhD
- Recruiting
York University
Toronto, Ontario
Matthew Keough, PhD, keoughmt@yorku.ca
About this study
Official title: UniVenture: A Partnership to Address Heavy Drinking and Other Substance Misuse on Canadian University Campuses
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.
Read the 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
- Being tested
- UniVenture Hopelessness manual, UniVenture Anxiety Sensitivity manual, UniVenture Sensation Seeking manual, UniVenture Impulsivity manual, Service as usual provided by the University
- Keywords
- Substance misuse, Prevention, Personality, Knowledge mobilization, Well-being, Academic retention, Academic performance, Binge drinking, Emerging adulthood, Life transitions, Technology assisted programs, Student services
- Medical subject headings
- Impulsive Behavior, Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UniVenture Hopelessness manualBehavioural
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 manualBehavioural
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 manualBehavioural
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 manualBehavioural
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).
Service as usual provided by the UniversityBehavioural
It is the regular university-provided well-being services.
| Study group | Role | What they receive |
|---|---|---|
| UniVenture- face-to-face (in-person format) | Experimental | 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) Receives: Behavioral: UniVenture Hopelessness manual; Behavioral: UniVenture Anxiety Sensitivity manual; Behavioral: UniVenture Sensation Seeking manual; Behavioral: UniVenture Impulsivity manual |
| UniVenture- online (distance-delivery format) | Active comparator | 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 Receives: Behavioral: UniVenture Hopelessness manual; Behavioral: UniVenture Anxiety Sensitivity manual; Behavioral: UniVenture Sensation Seeking manual; Behavioral: UniVenture Impulsivity manual |
| UniVenture- service as usual (control) | Placebo comparator | Services-as-usual offered by the respective university Receives: Behavioral: Service as usual provided by the University |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in alcohol-related harms in undergraduates
Alcohol use as a continuous measure of alcohol-related harm. The Brief-Young Adult Alcohol Consequences Questionnaire (B-YAACQ) is a 24-item scale that will be used to measure changes in the experiences of alcohol-related harms in the past 3 months. The response options include (1) Yes, in the past 3 months, (2) Yes, but not in the past 3 months (3) No. This measure will be scored as the number of adverse consequences experienced in the last three months on a continuous scale from 0-24.
[Higher scores indicate greater adverse alcohol consequences]
Measured: Past 3 months
Changes in cannabis-related harms in undergraduates
Cannabis use as a continuous measure of cannabis-related harm. The Brief Marijuana Consequences Questionnaire (BMACQ) is a 21-item scale that will be used to measure changes in participants' reported experiences of cannabis-related harms in the past 3 months. The response options include (1) Yes, in the past 3 months, (2) Yes, but not in the past 3 months (3) No. This measure will be scored as the number of adverse consequences experienced in the last three months on a continuous scale from 0-21.
[Higher scores indicate greater adverse cannabis consequences]
Measured: Past 3 months
Changes in the student wellbeing in undergraduates
It will be measured by the Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS) - which combines the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder (GAD-7) scales - as a composite measure of depression and anxiety. Response option of Generalized Anxiety Disorder (GAD-7) is (1) Not at all (2) Several days (3) More than half of the days (4) Nearly every day. Response option of Patient Health Questionnaire (PHQ-9) is (1) Not at all (2) Several days (3) Over half the days (4) Nearly every day.
[Higher scores indicate higher mental wellbeing]
Measured: Past 3 months
Secondary outcomes (5)
Differences in semester GPA between treatment groups.
Semester-wise grade point average [GPA] as a proxy of Undergraduates' academic performance (i.e., objective indices of grades). GPA data retrieved from the registrar's office at each site will be converted to a common 6-point GPA scale since different university sites use different GPA scales (%, 5-point GPA, 9-point GPA). The scale ranges from 1 to 6 where 1 indicates lower performance and 6 indicates higher performance.
[Higher scores indicate higher GPA in that semester.]
Measured: Through study completion, an average of 1 year
Changes in scores on the undergraduates' Academic retention measure
Measured by the 6-item self-reported Academic outcome survey: Academic experience scale. Item response options include (1) Strongly disagree (2) Disagree (3) Neither agree nor disagree (4) Agree (5) Strongly agree. A total score is derived by summing scores across the 6 items.
[Higher scores indicate higher academic retention].
Measured: Through study completion, an average of 1 year
Changes in scores on the undergraduates' Academic challenges measure
This is assessed with a 35-item Academic outcome survey. This composite score [Self-Regulated Learning -Challenges Scale (SRL-C)] will represent the academic challenges experienced. Item response options range from: (1) Strongly disagree to (5) Strongly agree.
The composite score is comprised of five areas of academic challenges typically reported by undergraduate students: (1) Motivation (e.g., challenges initiating and sustaining engagement); (2) Goal and time management (e.g., challenges making deadlines, or managing priorities) (3) Cognitive (challenges maintaining focus, understanding course material (4) Socio-emotional (challenges adjusting to new academic expectations; balancing health and well-being); and (5) Meta-cognitive (challenges setting goals or choosing strategies).
[Higher scores on the composite indicate greater levels of academic challenges being experienced by the student.]
Measured: Past 2 weeks
Changes in scores on the undergraduate self-regulated learning (SRL) behaviour measure and Self-efficacy beliefs for undergraduates' success measures
Two separate scales [SRL Self-Regulated Learning -Practices Scale (SRL-P) and Self-Regulated Learning -Challenges Scale (SRL-C)] will be combined and consist of 35 items from the Academic outcome survey with response options of (1) Strongly disagree (2) Disagree (3) Neutral (4) Agree (5) Strongly agree.
[Higher scores indicate more proactive self-regulated learning behaviours/practices and indicate stronger belief about academic success]
Measured: Past 2 weeks
Changes in score of hazardous drinkers in undergraduates
This 3-item The Alcohol Use Disorders Identification Test Consumption screening tool (AUDIT-C) questions (composite score) capture individuals who are hazardous drinkers or who have alcohol use disorders (including alcohol abuse or dependence). It is scored on a scale of 0-12 points (each item has maximum of 4 score where 0 reflect no alcohol use). In men, a score of 4 points or more is considered positive for alcohol misuse; in women, a score of 3 points or more is considered positive.
Generally, the higher the AUDIT-C score, the higher the likelihood of affecting health and safety due to individual's drinking.
Measured: Past 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start11 Sep 2021
- Primary completion8 Feb 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Anxiety SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherry Stewart
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University, St. Francis Xavier University, Université de Montréal, York University, University of British Columbia, University of Victoria, Canadian Centre on Substance Use and Addiction (CCSA), Canadian Research Initiative in Substance Misuse, Injury Free Nova Scotia (IFNS), Mental Health Commission of Canada (MHCC), Postsecondary Education Partnership - Alcohol Harms (PEP-AH), Strategy for Patient Orientated Research, SHARP- Students for Healthy Alternatives & Risk Prevention, Nova Scotia Health Authority
- Responsible party
- Sponsor-investigator, Sherry Stewart, Dalhousie University
- Investigators
- Sherry H Stewart, Study director, Dalhousie UniversityPatricia Conrod, Principal investigator, Université de MontréalKara Thompson, Principal investigator, St. Francis Xavier UniversityMatthew T Keough, Principal investigator, York UniversityMarvin Krank, Principal investigator, University of British Columbia- OkanaganAllyson Hadwin, Principal investigator, University of Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383989
- Sponsor's protocol ID
- 2021-5689
- Status last verified
- May 2022
- First submitted
- 27 Sep 2021
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Szalavitz, M. (2016, September 29). The 4 traits that put kids at risk for addiction. The New York Times. Retrieved from https://www.nytimes.com/2016/10/04/well/family/the-4-traits-that-put-kids-at- risk-for-addiction.html
Nair, R. (2017, January 22). Vernon, B. C. schools to pilot program that identifies addiction personality traits. CBC News. Retrieved from https://www.cbc.ca/news/canada/british-columbia/vernon-b- c-schools-to-pilot-program-thatidentifies-addiction-personality-traits-1.3942792
UNESCO, UNODC, & WHO. (2017). Education sector responses to the use of alcohol, tobacco and drugs. In the UNESCO series Good Policy and Practice in Health Education. Retrieved from http://www.who.int/substance_abuse/activities/education_sector/en/
Substance Abuse and Mental Health Services Administration (US); Office of the Surgeon General (US). Facing Addiction in America: The Surgeon General's Report on Alcohol, Drugs, and Health [Internet]. Washington (DC): US Department of Health and Human Services; 2016 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK424857/
PubMed 28252892Conrod PJ, Stewart SH, Comeau N, Maclean AM. Efficacy of cognitive-behavioral interventions targeting personality risk factors for youth alcohol misuse. J Clin Child Adolesc Psychol. 2006 Dec;35(4):550-63. doi: 10.1207/s15374424jccp3504_6.
PubMed 17007600Woicik PA, Stewart SH, Pihl RO, Conrod PJ. The Substance Use Risk Profile Scale: a scale measuring traits linked to reinforcement-specific substance use profiles. Addict Behav. 2009 Dec;34(12):1042-55. doi: 10.1016/j.addbeh.2009.07.001. Epub 2009 Jul 8.
PubMed 19683400Castellanos-Ryan, N., & Conrod, P. J. (2012). Personality and substance misuse: Evidence for a four-factor model of vulnerability. In Verster, J. C., Brady, K., Galanter, M., & Conrod, P. J. (Eds.), Drug abuse and addiction in medical illness: Causes, consequences and treatment (pp. 47-62). New York: Springer.
Stewart, S. H., Grant, V. V., Mackie, C. J., & Conrod, P. J. (2016). Comorbidity of anxiety and depression with substance use disorders. In K. Sher (Ed.), The Oxford Handbook of Substance Use Disorders. New York: Oxford University Press.
Conrod PJ, Pihl RO, Stewart SH, Dongier M. Validation of a system of classifying female substance abusers on the basis of personality and motivational risk factors for substance abuse. Psychol Addict Behav. 2000 Sep;14(3):243-56. doi: 10.1037//0893-164x.14.3.243.
PubMed 10998950Conrod PJ, Castellanos N, Mackie C. Personality-targeted interventions delay the growth of adolescent drinking and binge drinking. J Child Psychol Psychiatry. 2008 Feb;49(2):181-90. doi: 10.1111/j.1469-7610.2007.01826.x.
PubMed 18211277Conrod PJ, Castellanos-Ryan N, Strang J. Brief, personality-targeted coping skills interventions and survival as a non-drug user over a 2-year period during adolescence. Arch Gen Psychiatry. 2010 Jan;67(1):85-93. doi: 10.1001/archgenpsychiatry.2009.173.
PubMed 20048226O'Leary-Barrett M, Mackie CJ, Castellanos-Ryan N, Al-Khudhairy N, Conrod PJ. Personality-targeted interventions delay uptake of drinking and decrease risk of alcohol-related problems when delivered by teachers. J Am Acad Child Adolesc Psychiatry. 2010 Sep;49(9):954-963.e1. doi: 10.1016/j.jaac.2010.04.011. Epub 2010 Jul 31.
PubMed 20732631Castellanos, N., & Conrod, P. J. (2006). Brief interventions targeting personality risk factors for adolescent substance misuse reduce depression, panic, and risk-taking behaviors. Journal of Mental Health, 15, 645-658.
Mahu IT, Doucet C, O'Leary-Barrett M, Conrod PJ. Can cannabis use be prevented by targeting personality risk in schools? Twenty-four-month outcome of the adventure trial on cannabis use: a cluster-randomized controlled trial. Addiction. 2015 Oct;110(10):1625-33. doi: 10.1111/add.12991. Epub 2015 Jul 14.
PubMed 26011508MacLean's magazine (January 8, 2018). Canadian universities with the highest (and lowest) graduation rates. Retrieved from https://www.macleans.ca/education/canadian-universities-with-the- highest-and-lowest-graduation-rates/
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UniVenture: A Partnership to Address Heavy Drinking and Other Substance Misuse on Canadian University Campuses
- ClinicalTrials.gov ID
- NCT05383989
- Acronym / sponsor ID
- 2021-5689
- Conditions
- Anxiety Sensitivity, Hopelessness, Sensation Seeking, Impulsivity
- Keywords
- Substance misuse, Prevention, Personality, Knowledge mobilization, Well-being, Academic retention, Academic performance, Binge drinking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sherry StewartUniversity, hospital or other
- Collaborators
- Dalhousie University, St. Francis Xavier University, Université de Montréal, York University, University of British Columbia, University of Victoria, Canadian Centre on Substance Use and Addiction (CCSA), Canadian Research Initiative in Substance Misuse, Injury Free Nova Scotia (IFNS), Mental Health Commission of Canada (MHCC), Postsecondary Education Partnership - Alcohol Harms (PEP-AH), Strategy for Patient Orientated Research, SHARP- Students for Healthy Alternatives & Risk Prevention, Nova Scotia Health Authority
- Study start
- 11 Sep 2021 (actual)
- Primary completion
- 8 Feb 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| UniVenture- face-to-face (in-person format) | Experimental | Behavioral: UniVenture Hopelessness manual, Behavioral: UniVenture Anxiety Sensitivity manual, Behavioral: UniVenture Sensation Seeking manual, Behavioral: UniVenture Impulsivity manualPersonality-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) |
| UniVenture- online (distance-delivery format) | Active comparator | Behavioral: UniVenture Hopelessness manual, Behavioral: UniVenture Anxiety Sensitivity manual, Behavioral: UniVenture Sensation Seeking manual, Behavioral: UniVenture Impulsivity manualPersonality-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 |
| UniVenture- service as usual (control) | Placebo comparator | Behavioral: Service as usual provided by the UniversityServices-as-usual offered by the respective university |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UniVenture Hopelessness manualIntended 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). | Behavioural | UniVenture- face-to-face (in-person format), UniVenture- online (distance-delivery format) |
| UniVenture Anxiety Sensitivity manualIntended 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). | Behavioural | UniVenture- face-to-face (in-person format), UniVenture- online (distance-delivery format) |
| UniVenture Sensation Seeking manualIntended 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) | Behavioural | UniVenture- face-to-face (in-person format), UniVenture- online (distance-delivery format) |
| UniVenture Impulsivity manualIntended 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). | Behavioural | UniVenture- face-to-face (in-person format), UniVenture- online (distance-delivery format) |
| Service as usual provided by the UniversityIt is the regular university-provided well-being services. | Behavioural | UniVenture- service as usual (control) |
Primary outcome
Changes in alcohol-related harms in undergraduates
Time frame: Past 3 months
Alcohol use as a continuous measure of alcohol-related harm. The Brief-Young Adult Alcohol Consequences Questionnaire (B-YAACQ) is a 24-item scale that will be used to measure changes in the experiences of alcohol-related harms in the past 3 months. The response options include (1) Yes, in the past 3 months, (2) Yes, but not in the past 3 months (3) No. This measure will be scored as the number of adverse consequences experienced in the last three months on a continuous scale from 0-24. [Higher scores indicate greater adverse alcohol consequences]
Changes in cannabis-related harms in undergraduates
Time frame: Past 3 months
Cannabis use as a continuous measure of cannabis-related harm. The Brief Marijuana Consequences Questionnaire (BMACQ) is a 21-item scale that will be used to measure changes in participants' reported experiences of cannabis-related harms in the past 3 months. The response options include (1) Yes, in the past 3 months, (2) Yes, but not in the past 3 months (3) No. This measure will be scored as the number of adverse consequences experienced in the last three months on a continuous scale from 0-21. [Higher scores indicate greater adverse cannabis consequences]
Changes in the student wellbeing in undergraduates
Time frame: Past 3 months
It will be measured by the Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS) - which combines the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder (GAD-7) scales - as a composite measure of depression and anxiety. Response option of Generalized Anxiety Disorder (GAD-7) is (1) Not at all (2) Several days (3) More than half of the days (4) Nearly every day. Response option of Patient Health Questionnaire (PHQ-9) is (1) Not at all (2) Several days (3) Over half the days (4) Nearly every day. [Higher scores indicate higher mental wellbeing]
5 secondary outcomes
Differences in semester GPA between treatment groups.
Time frame: Through study completion, an average of 1 year
Changes in scores on the undergraduates' Academic retention measure
Time frame: Through study completion, an average of 1 year
Changes in scores on the undergraduates' Academic challenges measure
Time frame: Past 2 weeks
Changes in scores on the undergraduate self-regulated learning (SRL) behaviour measure and Self-efficacy beliefs for undergraduates' success measures
Time frame: Past 2 weeks
Changes in score of hazardous drinkers in undergraduates
Time frame: Past 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- BackgroundSzalavitz, M. (2016, September 29). The 4 traits that put kids at risk for addiction. The New York Times. Retrieved from https://www.nytimes.com/2016/10/04/well/family/the-4-traits-that-put-kids-at- risk-for-addiction.html
- BackgroundNair, R. (2017, January 22). Vernon, B. C. schools to pilot program that identifies addiction personality traits. CBC News. Retrieved from https://www.cbc.ca/news/canada/british-columbia/vernon-b- c-schools-to-pilot-program-thatidentifies-addiction-personality-traits-1.3942792
- BackgroundUNESCO, UNODC, & WHO. (2017). Education sector responses to the use of alcohol, tobacco and drugs. In the UNESCO series Good Policy and Practice in Health Education. Retrieved from http://www.who.int/substance_abuse/activities/education_sector/en/
- Background: PubMed 28252892Substance Abuse and Mental Health Services Administration (US); Office of the Surgeon General (US). Facing Addiction in America: The Surgeon General's Report on Alcohol, Drugs, and Health [Internet]. Washington (DC): US Department of Health and Human Services; 2016 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK424857/
- Background: PubMed 17007600Conrod PJ, Stewart SH, Comeau N, Maclean AM. Efficacy of cognitive-behavioral interventions targeting personality risk factors for youth alcohol misuse. J Clin Child Adolesc Psychol. 2006 Dec;35(4):550-63. doi: 10.1207/s15374424jccp3504_6.
- Background: PubMed 19683400Woicik PA, Stewart SH, Pihl RO, Conrod PJ. The Substance Use Risk Profile Scale: a scale measuring traits linked to reinforcement-specific substance use profiles. Addict Behav. 2009 Dec;34(12):1042-55. doi: 10.1016/j.addbeh.2009.07.001. Epub 2009 Jul 8.
- BackgroundCastellanos-Ryan, N., & Conrod, P. J. (2012). Personality and substance misuse: Evidence for a four-factor model of vulnerability. In Verster, J. C., Brady, K., Galanter, M., & Conrod, P. J. (Eds.), Drug abuse and addiction in medical illness: Causes, consequences and treatment (pp. 47-62). New York: Springer.
- BackgroundStewart, S. H., Grant, V. V., Mackie, C. J., & Conrod, P. J. (2016). Comorbidity of anxiety and depression with substance use disorders. In K. Sher (Ed.), The Oxford Handbook of Substance Use Disorders. New York: Oxford University Press.
- Background: PubMed 10998950Conrod PJ, Pihl RO, Stewart SH, Dongier M. Validation of a system of classifying female substance abusers on the basis of personality and motivational risk factors for substance abuse. Psychol Addict Behav. 2000 Sep;14(3):243-56. doi: 10.1037//0893-164x.14.3.243.
- Background: PubMed 18211277Conrod PJ, Castellanos N, Mackie C. Personality-targeted interventions delay the growth of adolescent drinking and binge drinking. J Child Psychol Psychiatry. 2008 Feb;49(2):181-90. doi: 10.1111/j.1469-7610.2007.01826.x.
- Background: PubMed 20048226Conrod PJ, Castellanos-Ryan N, Strang J. Brief, personality-targeted coping skills interventions and survival as a non-drug user over a 2-year period during adolescence. Arch Gen Psychiatry. 2010 Jan;67(1):85-93. doi: 10.1001/archgenpsychiatry.2009.173.
- Background: PubMed 20732631O'Leary-Barrett M, Mackie CJ, Castellanos-Ryan N, Al-Khudhairy N, Conrod PJ. Personality-targeted interventions delay uptake of drinking and decrease risk of alcohol-related problems when delivered by teachers. J Am Acad Child Adolesc Psychiatry. 2010 Sep;49(9):954-963.e1. doi: 10.1016/j.jaac.2010.04.011. Epub 2010 Jul 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherry H Stewart study director
Dalhousie University
Patricia Conrod principal investigator
Université de Montréal
Kara Thompson principal investigator
St. Francis Xavier University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UniVenture Hopelessness manual, UniVenture Anxiety Sensitivity manual and UniVenture Sensation Seeking manual in people with Anxiety Sensitivity and Hopelessness, run by Sherry Stewart at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fakir Md Yunus (306-514-0055, fakir.yunus@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in alcohol-related harms in undergraduates (time frame: Past 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05383989, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.