Substance UseiSTARTNCT05362357
iSTART: A Campus & Community Initiative for Services in Tec-health
A study testing iSTART Web-app in people with Substance Use and Binge Drinking, run by California State University, Northridge at 1 site in United States.
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)… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Binge Drinking, Marijuana Use
- What is being tested?
- iSTART Web-app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2021to 4 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current Cal State Northridge (CSUN) matriculated students
- Age 18-30
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
California State University, Northridge
Northridge, California, 91330
About this study
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.
- Conditions
- Substance Use, Binge Drinking, Marijuana Use, Alcohol Drinking, Prescription Opioid Misuse, Illicit Drug Use
- Being tested
- iSTART Web-app
- Keywords
- Web-app, Module, mHealth
- Medical subject headings
- Substance-Related Disorders, Binge Drinking, Marijuana Use, Alcohol Drinking, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSTART Web-appBehavioural
30-day substance prevention web-app for students at a Hispanic Serving Institution.
| Study group | Role | What they receive |
|---|---|---|
| Prevention Group | Experimental | Web-app with five weekly substance modules. Each module is approximately 15 minutes long. Receives: Behavioral: iSTART Web-app |
| Comparison Group | Active comparator | Web-app with single abbreviated module combining all five substances. Module is approximately 20 minutes long. Receives: Behavioral: iSTART Web-app |
| Control Group | No intervention | No access to web-app. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline alcohol use behavior at 3 months.
Measured as the number of days drinking alcohol in past 30-days
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 90-days following intervention completion.
Secondary outcomes (2)
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.
Measured: Baseline and 90-days following intervention completion.
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.
Measured: Baseline and 90-days following intervention completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start20 Feb 2021
- Primary completion15 Nov 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- California State University, Northridge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bethany Rainisch, California State University, Northridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362357
- Sponsor's protocol ID
- H79SP021733
- Acronym
- iSTART
- Status last verified
- Feb 2024
- First submitted
- 28 Apr 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 35705975
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iSTART: A Campus & Community Initiative for Services in Tec-health
- ClinicalTrials.gov ID
- NCT05362357
- Acronym / sponsor ID
- iSTART / H79SP021733
- Conditions
- Substance Use, Binge Drinking, Marijuana Use, Alcohol Drinking, Prescription Opioid Misuse, Illicit Drug Use
- Keywords
- Web-app, Module, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- California State University, NorthridgeUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prevention Group | Experimental | Behavioral: iSTART Web-appWeb-app with five weekly substance modules. Each module is approximately 15 minutes long. |
| Comparison Group | Active comparator | Behavioral: iSTART Web-appWeb-app with single abbreviated module combining all five substances. Module is approximately 20 minutes long. |
| Control Group | No intervention | –No access to web-app. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Current Cal State Northridge (CSUN) matriculated students
- Age 18-30
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iSTART Web-app30-day substance prevention web-app for students at a Hispanic Serving Institution. | Behavioural | Comparison Group, Prevention Group |
Primary outcome
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.
2 secondary outcomes
Change from baseline behavioral intent at 3 months.
Time frame: Baseline and 90-days following intervention completion.
Change from baseline alcohol-specific outcomes at 3 months.
Time frame: Baseline and 90-days following intervention completion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Derived from this study: PubMed 35705975Rainisch 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iSTART Web-app in people with Substance Use and Binge Drinking, run by California State University, Northridge at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline alcohol use behavior at 3 months. (time frame: Baseline and 90-days following intervention completion.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05362357, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.