NCT06553196

Brief Summary

The MATAspire intervention is a web-app designed to promote substance misuse prevention education and bolster protective coping skills whereby students complete six weekly interactive modules using a smart device or computer. Each module is approximately 15-20 minutes long and focuses on select substances and coping strategies: (i) adaptive coping strategies, (ii) alcohol, (iii) cannabis, (iv) nicotine, (v) prescription drugs and opioids, (vi) final module. The modules are based on key theoretical constructs, behavior change strategies, and practical module components: attitudes (knowledge), perceived susceptibility (risk perceptions), and subjective norms (normative re-education). The intervention will be evaluated via a time series design using a sample of (\~1000 students) randomly assigned to either the intervention or the control conditions at a public institution in Southern California.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Aug 2024

Longer than P75 for not_applicable

Status
not yet recruiting

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 Progress42%
Aug 2024Dec 2028

First Submitted

Initial submission to the registry

August 8, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

August 24, 2024

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

3.7 years

First QC Date

August 8, 2024

Last Update Submit

August 12, 2024

Conditions

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 cannabis use at 3 months

    Measured as the number of days smoking, vaping, dabbing, oral (edibles/gummies/drinks), sprays, tinctures, and topically in past 30-days

    Baseline and 90-days following intervention completion

  • Change from baseline nicotine use at 3 months

    Measured as the number of days using menthol cigarettes, regular cigarettes, loose tobacco rolled into cigarettes or cigars, pipe tobacco, snuff, chewing tobacco, dipping tobacco, snus, and others in past 30-days

    Baseline and 90-days following intervention completion

  • Change from baseline electronic vape use products at 3 months

    Measured as the number of days using vaporizers, vape pens, hookah pens, electronic cigarettes, e-pens, or electronic nicotine delivery systems in past 30-days

    Baseline and 90-days following intervention

  • Change from baseline non-prescribed prescription drug use behavior 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 coping skills at 3 months

    Measured as the degree of effective and ineffective ways to cope with a stressful life event in ...

    Baseline and 90-days following intervention completion

Secondary Outcomes (4)

  • Change from baseline alcohol use related outcomes at 3 months

    Baseline and 90-days following intervention completion

  • Change from baseline nicotine use related outcomes at 3 months

    Baseline and 90-days following intervention completion

  • Change from baseline cannabis use related outcomes at 3 months

    Baseline and 90-days following intervention completion

  • Change from baseline non-prescribed prescription drug use related outcomes at 3 months

    Baseline and 90-days following completion of intervention

Other Outcomes (11)

  • 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 attitudes at 3 months

    Baseline and 90-days following intervention completion

  • +8 more other outcomes

Study Arms (2)

Prevention group

EXPERIMENTAL

Web-app with 6 weekly coping \& substance modules

Behavioral: MATAspire Web-app

Control Group

NO INTERVENTION

No access to web-app

Interventions

Substance misuse prevention education and adaptive coping skills

Prevention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current Cal State Northridge (CSUN) matriculated students with active CSUN email
  • Age 18 and older

You may not qualify if:

  • Not currently a CSUN student
  • CSUN students under the age of 18 years
  • Have previously participated in this study
  • Identified as having an alcohol or substance use disorder (AUD or SUD) as determined by the brief Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 screener

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Alcohol DrinkingOpioid-Related Disorders

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Bethany Rainisch, PhD, MPH

CONTACT

Linn Dahlman, MPhil

CONTACT

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, Department Chair, Professor

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 14, 2024

Study Start

August 24, 2024

Primary Completion (Estimated)

May 15, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

August 14, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share