An interventional study of iSTART Web-app in Substance Use, Binge Drinking and Marijuana Use, sponsored by California State University, Northridge. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by California State University, Northridge · Not applicable, Interventional, and Prevention
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.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's enrollment of 1,100 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →California State University, Northridge is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Web-app with five weekly substance modules. Each module is approximately 15 minutes long.
Behavioral: iSTART Web-app
Web-app with single abbreviated module combining all five substances. Module is approximately 20 minutes long.
Behavioral: iSTART Web-app
No access to web-app.
30-day substance prevention web-app for students at a Hispanic Serving Institution.
Change from baseline alcohol use behavior at 3 months.
Measured as the number of days drinking alcohol in past 30-days
Time frame: Baseline and 90-days following intervention completion.
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.
Time frame: Baseline and 90-days following intervention completion.
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.
Time frame: Baseline and 90-days following intervention completion.
Change from baseline electronic vaping at 3 months.
Measured as the number of days vaped in past 30-days.
Time frame: Baseline and 90-days following intervention completion.
Change from baseline marijuana use at 3 months.
Measured as the number of days smoked marijuana in past 30-days.
Time frame: Baseline and 90-days following intervention completion.
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.
Time frame: Baseline and 90-days following intervention completion.
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.
Time frame: Baseline and 90-days following intervention completion.
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.
Time frame: Baseline and 90-days following intervention completion.
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.
Time frame: Baseline and 90-days following intervention completion.
Change from baseline risk perceptions at 3 months.
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.
Change from baseline subjective norms at 3 months.
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.
Change from baseline refusal self-efficacy at 3 months.
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.
Socio-demographics
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
Adverse Childhood Experiences (ACE)
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
Developmental transition
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
Plan to share: Undecided — 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.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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California State University, Northridge