We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05362357
Recruitment Status : Recruiting
First Posted : May 5, 2022
Last Update Posted : May 5, 2022
Sponsor:
Information provided by (Responsible Party):
Bethany Rainisch, California State University, Northridge

Tracking Information
First Submitted Date  ICMJE April 28, 2022
First Posted Date  ICMJE May 5, 2022
Last Update Posted Date May 5, 2022
Actual Study Start Date  ICMJE February 20, 2021
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2022)
  • Change from baseline alcohol use behavior at 3 months. [ Time Frame: Baseline and 90-days following intervention completion. ]
    Measured as the number of days drinking alcohol in past 30-days
  • Change from baseline binge drinking at 3 months. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Baseline and 90-days following intervention completion. ]
    Measured as the number of days used stimulants, sedatives, benzodiazepines, and prescription opioids in past 30-days.
  • Change from baseline illicit drug use at 3 months. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2022)
  • Change from baseline behavioral intent at 3 months. [ Time Frame: 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. [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 2, 2022)
  • Change from baseline risk perceptions at 3 months. [ Time Frame: Baseline and 90-days following intervention completion. ]
    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'.
  • Change from baseline subjective norms at 3 months. [ Time Frame: Baseline and 90-days following intervention completion. ]
    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%.
  • Change from baseline refusal self-efficacy at 3 months. [ Time Frame: Baseline and 90-days following intervention completion. ]
    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'.
  • Socio-demographics [ Time Frame: Baseline ]
    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
  • Adverse Childhood Experiences (ACE) [ Time Frame: Baseline ]
    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.
  • Developmental transition [ Time Frame: Baseline ]
    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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE iSTART: A Campus & Community Initiative for Services in Tec-health
Official Title  ICMJE iSTART: A Campus & Community Initiative for Services in Tec-health
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Substance Use
  • Binge Drinking
  • Marijuana Use
  • Alcohol Drinking
  • Prescription Opioid Misuse
  • Illicit Drug Use
Intervention  ICMJE Behavioral: iSTART Web-app
30-day substance prevention web-app for students at a Hispanic Serving Institution.
Study Arms  ICMJE
  • Experimental: Prevention Group
    Web-app with five weekly substance modules. Each module is approximately 15 minutes long.
    Intervention: Behavioral: iSTART Web-app
  • Active Comparator: Comparison Group
    Web-app with single abbreviated module combining all five substances. Module is approximately 20 minutes long.
    Intervention: Behavioral: iSTART Web-app
  • No Intervention: Control Group
    No access to web-app.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2022)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Bethany Rainisch, PhD, MPH 818-677-2341 bethany.rainisch@csun.edu
Contact: Linn Dahlman, MPhil 818-677-5397 linn.dahlman@csun.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05362357
Other Study ID Numbers  ICMJE H79SP021733
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Once the study is complete, the PI and evaluator will determine whether IPD will be made available to other researchers beyond traditional research dissemination via peer-reviewed journal articles and conference presentations.
Current Responsible Party Bethany Rainisch, California State University, Northridge
Original Responsible Party Same as current
Current Study Sponsor  ICMJE California State University, Northridge
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account California State University, Northridge
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP