Clinical trial NCT05362357: iSTART: A Campus & Community Initiative for Services in Tec-health
Official title: iSTART: A Campus & Community Initiative for Services in Tec-health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Binge Drinking
Marijuana Use
Alcohol Drinking
Prescription Opioid Misuse
Illicit Drug Use
Keywords: Web-app
Module
mHealth
Lead sponsor: California State University, Northridge
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change from baseline alcohol use behavior at 3 months.
timeFrame: Baseline and 90-days following intervention completion.
measure: Change from baseline binge drinking at 3 months.
timeFrame: Baseline and 90-days following intervention completion.
measure: Change from baseline tobacco use at 3 months.
timeFrame: Baseline and 90-days following intervention completion.
measure: Change from baseline electronic vaping at 3 months.
timeFrame: Baseline and 90-days following intervention completion.
measure: Change from baseline marijuana use at 3 months.
timeFrame: Baseline and 90-days following intervention completion.
measure: Change from baseline non-prescribed prescription drug use at 3 months.
timeFrame: Baseline and 90-days following intervention completion.
measure: Change from baseline illicit drug use at 3 months.
timeFrame: Baseline and 90-days following intervention completion.
Secondary outcomes:
measure: Change from baseline behavioral intent at 3 months.
timeFrame: Baseline and 90-days following intervention completion.
measure: Change from baseline alcohol-specific outcomes at 3 months.
timeFrame: Baseline and 90-days following intervention completion.
Other outcomes:
measure: Change from baseline risk perceptions at 3 months.
timeFrame: Baseline and 90-days following intervention completion.
measure: Change from baseline subjective norms at 3 months.
timeFrame: Baseline and 90-days following intervention completion.
measure: Change from baseline refusal self-efficacy at 3 months.
timeFrame: Baseline and 90-days following intervention completion.
measure: Socio-demographics
timeFrame: Baseline
measure: Adverse Childhood Experiences (ACE)
timeFrame: Baseline
measure: Developmental transition
timeFrame: Baseline
Locations:
city: Northridge
country: United States
facility: California State University, Northridge
state: California
Study officials:
References:
citation: Rainisch BKW, Dahlman L, Vigil J, Forster M. Using a multi-module web-app to prevent substance use among students at a Hispanic Serving Institution: development and evaluation design. BMC Public Health. 2022 Jun 15;22(1):1198. doi: 10.1186/s12889-022-13428-x.