NCT05362357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

2.7 years

First QC Date

April 28, 2022

Last Update Submit

February 5, 2024

Conditions

Keywords

Web-appModulemHealth

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (2)

  • Change from baseline behavioral intent at 3 months.

    Baseline and 90-days following intervention completion.

  • Change from baseline alcohol-specific outcomes at 3 months.

    Baseline and 90-days following intervention completion.

Other Outcomes (6)

  • Change from baseline risk perceptions at 3 months.

    Baseline and 90-days following intervention completion.

  • Change from baseline subjective norms at 3 months.

    Baseline and 90-days following intervention completion.

  • Change from baseline refusal self-efficacy at 3 months.

    Baseline and 90-days following intervention completion.

  • +3 more other outcomes

Study Arms (3)

Prevention Group

EXPERIMENTAL

Web-app with five weekly substance modules. Each module is approximately 15 minutes long.

Behavioral: iSTART Web-app

Comparison Group

ACTIVE COMPARATOR

Web-app with single abbreviated module combining all five substances. Module is approximately 20 minutes long.

Behavioral: iSTART Web-app

Control Group

NO INTERVENTION

No access to web-app.

Interventions

iSTART Web-appBEHAVIORAL

30-day substance prevention web-app for students at a Hispanic Serving Institution.

Comparison GroupPrevention Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Current Cal State Northridge (CSUN) matriculated students
  • Age 18-30

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California State University, Northridge

Northridge, California, 91330, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Substance-Related DisordersBinge DrinkingMarijuana UseAlcohol DrinkingOpioid-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAlcohol-Related DisordersDrinking BehaviorBehaviorNarcotic-Related Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Associate Professor

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 5, 2022

Study Start

February 20, 2021

Primary Completion

November 15, 2023

Study Completion

December 4, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations