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

Alcohol Drinking Clinical Trial

— iSTART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05362357
• Other study ID #: H79SP021733
• Status: Completed
• Phase: N/A
• Start date: February 20, 2021
• Est. completion date: December 4, 2023

Study information

• Verified date: February 2024
• Source: California State University, Northridge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: December 4, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Binge Drinking
• Illicit Drug Use
• Marijuana Use
• Opioid-Related Disorders
• Prescription Opioid Misuse
• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• iSTART Web-app
30-day substance prevention web-app for students at a Hispanic Serving Institution.

Locations

Country	Name	City	State
United States	California State University, Northridge	Northridge	California

Sponsors (1)

Lead Sponsor	Collaborator
California State University, Northridge

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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'.	Baseline and 90-days following intervention completion.
Other	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%.	Baseline and 90-days following intervention completion.
Other	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'.	Baseline and 90-days following intervention completion.
Other	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	Baseline
Other	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.	Baseline
Other	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.	Baseline
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.