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

Not Applicable

Completed

• Conditions: Binge Drinking; Marijuana Use; Alcohol Drinking; Prescription Opioid Misuse; Substance Use; Illicit Drug Use
• Interventions: Behavioral: iSTART Web-app

• Registration Number: NCT05362357
• Lead Sponsor: California State University, Northridge

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-20
• Study First Submitted: 2022-04-28
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-05
• Primary Completion: 2023-11-15
• Study Completion: 2023-12-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prevention Group	iSTART Web-app	Web-app with five weekly substance modules. Each module is approximately 15 minutes long.
Comparison Group	iSTART Web-app	Web-app with single abbreviated module combining all five substances. Module is approximately 20 minutes long.

Primary Outcome Measures

Name	Time	Method
Change from baseline alcohol use behavior at 3 months.	Baseline and 90-days following intervention completion.	Measured as the number of days drinking alcohol in past 30-days
Change from baseline illicit drug use at 3 months.	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.
Change from baseline binge drinking at 3 months.	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.
Change from baseline tobacco use at 3 months.	Baseline and 90-days following intervention completion.	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.	Baseline and 90-days following intervention completion.	Measured as the number of days vaped in past 30-days.
Change from baseline marijuana use at 3 months.	Baseline and 90-days following intervention completion.	Measured as the number of days smoked marijuana in past 30-days.
Change from baseline non-prescribed prescription drug use at 3 months.	Baseline and 90-days following intervention completion.	Measured as the number of days used stimulants, sedatives, benzodiazepines, and prescription opioids in past 30-days.

Secondary Outcome Measures

Name	Time	Method
Change from baseline behavioral intent at 3 months.	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.
Change from baseline alcohol-specific outcomes at 3 months.	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.

Trial Locations

Locations (1)

California State University, Northridge; 🇺🇸 Northridge, California, United States