iSTART: A Campus & Community Initiative for Services in Tec-health (iSTART)
Primary Purpose
Substance Use, Binge Drinking, Marijuana Use
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iSTART Web-app
Sponsored by
About this trial
This is an interventional prevention trial for Substance Use focused on measuring Web-app, Module, mHealth
Eligibility Criteria
Inclusion Criteria:
- Current Cal State Northridge (CSUN) matriculated students
- Age 18-30
Exclusion Criteria:
- Not currently a CSUN student
- Not 18-30 years of age
- Identified as having an alcohol or substance use disorder (AUD or SUD) as determined by the brief DSM-5 screener
Sites / Locations
- California State University, NorthridgeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Prevention Group
Comparison Group
Control Group
Arm Description
Web-app with five weekly substance modules. Each module is approximately 15 minutes long.
Web-app with single abbreviated module combining all five substances. Module is approximately 20 minutes long.
No access to web-app.
Outcomes
Primary Outcome Measures
Change from baseline alcohol use behavior at 3 months.
Measured as the number of days drinking alcohol in past 30-days
Change from baseline binge drinking at 3 months.
Measured as the number of days consumed five or more alcoholic beverages at the same time for males; four or more for females in past 30-days.
Change from baseline tobacco use at 3 months.
Measured as the number of days using cigarettes, pipe tobacco, chewing tobacco, snus in past 30-days.
Change from baseline electronic vaping at 3 months.
Measured as the number of days vaped in past 30-days.
Change from baseline marijuana use at 3 months.
Measured as the number of days smoked marijuana in past 30-days.
Change from baseline non-prescribed prescription drug use at 3 months.
Measured as the number of days used stimulants, sedatives, benzodiazepines, and prescription opioids in past 30-days.
Change from baseline illicit drug use at 3 months.
Measured as the number of days used cocaine, amphetamines, MDMA/Ecstasy, heroin, fentanyl, and non-Rx opioids in past 30-days.
Secondary Outcome Measures
Change from baseline behavioral intent at 3 months.
Measured as the intent to smoke marijuana/cigarettes, binge drink, and use non-prescribed drugs. Participants are asked to rate the likelihood of use in the next 30 days on a four-point Likert scale from 1=very likely to 4=very unlikely.
Change from baseline alcohol-specific outcomes at 3 months.
Measured as participants who report any past 30-day alcohol use indicate how many times they have experienced ten select outcomes in the last 30 days while drinking alcohol, or as the result of their alcohol use. Example items include: 'Not being able to do your homework or study for a test', 'Missed out on other things because you spent too much money on alcohol', 'Went to work or school high or drunk', 'Felt that you needed more alcohol than you used to use in order to get the same effect', and 'Had withdrawal symptoms, that is, felt sick because you stopped or cut down on drinking'. Participants respond: 'never', '1-2 times', '3-5 times', '6-10 times', and 'more than 10 times' in the past 30-days.
Full Information
NCT ID
NCT05362357
First Posted
April 28, 2022
Last Updated
May 2, 2022
Sponsor
California State University, Northridge
1. Study Identification
Unique Protocol Identification Number
NCT05362357
Brief Title
iSTART: A Campus & Community Initiative for Services in Tec-health
Acronym
iSTART
Official Title
iSTART: A Campus & Community Initiative for Services in Tec-health
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2021 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California State University, Northridge
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The iSTART intervention is a 30-day substance prevention web-app whereby students complete five weekly interactive modules using a smart device or computer. Each module is approximately 15 minutes long, and focuses on a select substance: (i) alcohol, (ii) marijuana, (iii) nicotine, (iv) prescription drugs, and (v) illicit drugs. The modules are based on key theoretical constructs, behavior change strategies, and practical module components: attitudes (knowledge), perceived susceptibility (risk perceptions), subjective norms (normative re-education), and self-efficacy (refusal skills). This intervention will be evaluated via a time series design using a sample of 600 students randomly assigned to either the intervention, comparison, or control condition at a public institution in southern California.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Binge Drinking, Marijuana Use, Alcohol Drinking, Prescription Opioid Misuse, Illicit Drug Use
Keywords
Web-app, Module, mHealth
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prevention Group
Arm Type
Experimental
Arm Description
Web-app with five weekly substance modules. Each module is approximately 15 minutes long.
Arm Title
Comparison Group
Arm Type
Active Comparator
Arm Description
Web-app with single abbreviated module combining all five substances. Module is approximately 20 minutes long.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No access to web-app.
Intervention Type
Behavioral
Intervention Name(s)
iSTART Web-app
Intervention Description
30-day substance prevention web-app for students at a Hispanic Serving Institution.
Primary Outcome Measure Information:
Title
Change from baseline alcohol use behavior at 3 months.
Description
Measured as the number of days drinking alcohol in past 30-days
Time Frame
Baseline and 90-days following intervention completion.
Title
Change from baseline binge drinking at 3 months.
Description
Measured as the number of days consumed five or more alcoholic beverages at the same time for males; four or more for females in past 30-days.
Time Frame
Baseline and 90-days following intervention completion.
Title
Change from baseline tobacco use at 3 months.
Description
Measured as the number of days using cigarettes, pipe tobacco, chewing tobacco, snus in past 30-days.
Time Frame
Baseline and 90-days following intervention completion.
Title
Change from baseline electronic vaping at 3 months.
Description
Measured as the number of days vaped in past 30-days.
Time Frame
Baseline and 90-days following intervention completion.
Title
Change from baseline marijuana use at 3 months.
Description
Measured as the number of days smoked marijuana in past 30-days.
Time Frame
Baseline and 90-days following intervention completion.
Title
Change from baseline non-prescribed prescription drug use at 3 months.
Description
Measured as the number of days used stimulants, sedatives, benzodiazepines, and prescription opioids in past 30-days.
Time Frame
Baseline and 90-days following intervention completion.
Title
Change from baseline illicit drug use at 3 months.
Description
Measured as the number of days used cocaine, amphetamines, MDMA/Ecstasy, heroin, fentanyl, and non-Rx opioids in past 30-days.
Time Frame
Baseline and 90-days following intervention completion.
Secondary Outcome Measure Information:
Title
Change from baseline behavioral intent at 3 months.
Description
Measured as the intent to smoke marijuana/cigarettes, binge drink, and use non-prescribed drugs. Participants are asked to rate the likelihood of use in the next 30 days on a four-point Likert scale from 1=very likely to 4=very unlikely.
Time Frame
Baseline and 90-days following intervention completion.
Title
Change from baseline alcohol-specific outcomes at 3 months.
Description
Measured as participants who report any past 30-day alcohol use indicate how many times they have experienced ten select outcomes in the last 30 days while drinking alcohol, or as the result of their alcohol use. Example items include: 'Not being able to do your homework or study for a test', 'Missed out on other things because you spent too much money on alcohol', 'Went to work or school high or drunk', 'Felt that you needed more alcohol than you used to use in order to get the same effect', and 'Had withdrawal symptoms, that is, felt sick because you stopped or cut down on drinking'. Participants respond: 'never', '1-2 times', '3-5 times', '6-10 times', and 'more than 10 times' in the past 30-days.
Time Frame
Baseline and 90-days following intervention completion.
Other Pre-specified Outcome Measures:
Title
Change from baseline risk perceptions at 3 months.
Description
Measured by participants' evaluation of their perceived risk level for the following six substance use behaviors: binge drinking once or twice a week, tobacco use once or twice a week, marijuana use once or twice a week, prescription opioid use once or twice a week, non-prescription opioid use once or twice a week, sharing needles/injection equipment, injecting drugs, and illicit drug use. Response options for each behavior include 1='no risk', 2='slight risk', 3='moderate risk', 4='great risk', or 9='don't know'.
Time Frame
Baseline and 90-days following intervention completion.
Title
Change from baseline subjective norms at 3 months.
Description
Measured by participants' indication of what percentage of students on campus they perceive use a variety of substances within the last 30 days, (i.e., alcohol, cigarettes, marijuana, different prescription drugs, and several illicit drugs) choosing one of ten percentile intervals from 0-100%.
Time Frame
Baseline and 90-days following intervention completion.
Title
Change from baseline refusal self-efficacy at 3 months.
Description
Self-efficacy will be evaluated through two refusal skills statements: "I would be able to say no if a friend offered me a drink of alcohol" and "I would be able to refuse if a friend offered me drugs, including marijuana", by indicating their level of agreement on a four-point Likert scale from 1='strongly agree' to 4='strongly disagree'.
Time Frame
Baseline and 90-days following intervention completion.
Title
Socio-demographics
Description
Participant characteristics, including age, Hispanic origin, race, sex at birth, gender identification, sexual orientation, living situation, college status, military service/veteran status, arrest history, parole/probation status, and household income
Time Frame
Baseline
Title
Adverse Childhood Experiences (ACE)
Description
ACE are conceptualized as maltreatment (e.g., verbal, emotional, physical, and sexual abuse), and household dysfunction (e.g., parent/caregiver substance use, intimate partner violence, incarceration, homelessness, mental illness, separation/divorce (71). Participants respond to each of the ten ACE items as 1=Yes or 0=No. An ACE score will be computed with a range from 0-10.
Time Frame
Baseline
Title
Developmental transition
Description
Participants respond 1=Yes or 0=No to a list of 18 major life events within the last three years. Example life events include: getting into a new romantic relationship; breaking up with a girlfriend or boyfriend; losing a job; being unemployed and not able to find work; caring for a parent or relative; getting extremely ill; having a baby; losing a baby; or having family separated due to immigration. A total score will be computed with a range from 0-18.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Current Cal State Northridge (CSUN) matriculated students
Age 18-30
Exclusion Criteria:
Not currently a CSUN student
Not 18-30 years of age
Identified as having an alcohol or substance use disorder (AUD or SUD) as determined by the brief DSM-5 screener
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bethany Rainisch, PhD, MPH
Phone
818-677-2341
Email
bethany.rainisch@csun.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Linn Dahlman, MPhil
Phone
818-677-5397
Email
linn.dahlman@csun.edu
Facility Information:
Facility Name
California State University, Northridge
City
Northridge
State/Province
California
ZIP/Postal Code
91330
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bethany Rainisch, PhD, MPH
Phone
818-677-2341
Email
bethany.rainisch@csun.edu
First Name & Middle Initial & Last Name & Degree
Linn Dahlman, MPhil
Phone
818-677-5397
Email
linn.dahlman@csun.edu
First Name & Middle Initial & Last Name & Degree
Bethany Rainisch, PhD, MPH
First Name & Middle Initial & Last Name & Degree
Myriam Forster, PhD, MPH
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Once the study is complete, the PI and evaluator will determine whether IPD will be made available to other researchers beyond traditional research dissemination via peer-reviewed journal articles and conference presentations.
Citations:
PubMed Identifier
35705975
Citation
Rainisch BKW, Dahlman L, Vigil J, Forster M. Using a multi-module web-app to prevent substance use among students at a Hispanic Serving Institution: development and evaluation design. BMC Public Health. 2022 Jun 15;22(1):1198. doi: 10.1186/s12889-022-13428-x.
Results Reference
derived
Learn more about this trial
iSTART: A Campus & Community Initiative for Services in Tec-health
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