iSTART: A Campus & Community Initiative for Services in Tec-health

Study Overview
=================
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.

Official Title
-----------------
iSTART: A Campus & Community Initiative for Services in Tec-health

Conditions
-----------------
Substance Use, Binge Drinking, Marijuana Use, Alcohol Drinking, Prescription Opioid Misuse, Illicit Drug Use

Intervention / Treatment
-----------------
* Behavioral: iSTART Web-app


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention Group<br>Web-app with five weekly substance modules. Each module is approximately 15 minutes long. | Behavioral: iSTART Web-app<br>* 30-day substance prevention web-app for students at a Hispanic Serving Institution.<br>|
| Active Comparator: Comparison Group<br>Web-app with single abbreviated module combining all five substances. Module is approximately 20 minutes long. | Behavioral: iSTART Web-app<br>* 30-day substance prevention web-app for students at a Hispanic Serving Institution.<br>|
| No Intervention: Control Group<br>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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Web-app, Module, mHealth