- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05362357
iSTART: A Campus & Community Initiative for Services in Tec-health (iSTART)
February 5, 2024 updated by: Bethany Rainisch, California State University, Northridge
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bethany Rainisch, PhD, MPH
- Phone Number: 818-677-2341
- Email: bethany.rainisch@csun.edu
Study Contact Backup
- Name: Linn Dahlman, MPhil
- Phone Number: 818-677-5397
- Email: linn.dahlman@csun.edu
Study Locations
-
-
California
-
Northridge, California, United States, 91330
- California State University, Northridge
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prevention Group
Web-app with five weekly substance modules.
Each module is approximately 15 minutes long.
|
30-day substance prevention web-app for students at a Hispanic Serving Institution.
|
Active Comparator: Comparison Group
Web-app with single abbreviated module combining all five substances.
Module is approximately 20 minutes long.
|
30-day substance prevention web-app for students at a Hispanic Serving Institution.
|
No Intervention: Control Group
No access to web-app.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline alcohol use behavior at 3 months.
Time Frame: Baseline and 90-days following intervention completion.
|
Measured as the number of days drinking alcohol in past 30-days
|
Baseline and 90-days following intervention completion.
|
Change from baseline binge drinking at 3 months.
Time Frame: Baseline and 90-days following intervention completion.
|
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.
|
Baseline and 90-days following intervention completion.
|
Change from baseline tobacco use at 3 months.
Time Frame: Baseline and 90-days following intervention completion.
|
Measured as the number of days using cigarettes, pipe tobacco, chewing tobacco, snus in past 30-days.
|
Baseline and 90-days following intervention completion.
|
Change from baseline electronic vaping at 3 months.
Time Frame: Baseline and 90-days following intervention completion.
|
Measured as the number of days vaped in past 30-days.
|
Baseline and 90-days following intervention completion.
|
Change from baseline marijuana use at 3 months.
Time Frame: Baseline and 90-days following intervention completion.
|
Measured as the number of days smoked marijuana in past 30-days.
|
Baseline and 90-days following intervention completion.
|
Change from baseline non-prescribed prescription drug use at 3 months.
Time Frame: Baseline and 90-days following intervention completion.
|
Measured as the number of days used stimulants, sedatives, benzodiazepines, and prescription opioids in past 30-days.
|
Baseline and 90-days following intervention completion.
|
Change from baseline illicit drug use at 3 months.
Time Frame: Baseline and 90-days following intervention completion.
|
Measured as the number of days used cocaine, amphetamines, MDMA/Ecstasy, heroin, fentanyl, and non-Rx opioids in past 30-days.
|
Baseline and 90-days following intervention completion.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline behavioral intent at 3 months.
Time Frame: Baseline and 90-days following intervention completion.
|
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.
|
Baseline and 90-days following intervention completion.
|
Change from baseline alcohol-specific outcomes at 3 months.
Time Frame: Baseline and 90-days following intervention completion.
|
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.
|
Baseline and 90-days following intervention completion.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline risk perceptions at 3 months.
Time Frame: Baseline and 90-days following intervention completion.
|
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'.
|
Baseline and 90-days following intervention completion.
|
Change from baseline subjective norms at 3 months.
Time Frame: Baseline and 90-days following intervention completion.
|
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%.
|
Baseline and 90-days following intervention completion.
|
Change from baseline refusal self-efficacy at 3 months.
Time Frame: Baseline and 90-days following intervention completion.
|
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'.
|
Baseline and 90-days following intervention completion.
|
Socio-demographics
Time Frame: Baseline
|
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
|
Baseline
|
Adverse Childhood Experiences (ACE)
Time Frame: Baseline
|
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.
|
Baseline
|
Developmental transition
Time Frame: Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 20, 2021
Primary Completion (Actual)
November 15, 2023
Study Completion (Actual)
December 4, 2023
Study Registration Dates
First Submitted
April 28, 2022
First Submitted That Met QC Criteria
May 2, 2022
First Posted (Actual)
May 5, 2022
Study Record Updates
Last Update Posted (Actual)
February 7, 2024
Last Update Submitted That Met QC Criteria
February 5, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H79SP021733
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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