N/A
N=162
Enhancing Quality in Protective Strategies
Health Risk Behaviors · Risk Reduction Behavior
Bottom Line
View on ClinicalTrials.gov: NCT04978129 ↗Enrolled (actual)
162
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Typical Number of Drinks Per Occasion — 3.75; 3.67 Typical number of drinks per occasion
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Online and Text Messaging Intervention (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Texas Health Science Center
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Typical Number of Drinks Per Occasion |
2.85; 3.05 | — |
| PRIMARY Typical Number of Drinks Per Occasion |
2.85; 3.05 | — |
| PRIMARY Young Adult Alcohol Consequences Questionnaire |
5.97; 5.78 | — |
| PRIMARY Young Adult Alcohol Consequences Questionnaire |
5.97; 5.78 | — |
| PRIMARY Alcohol Protective Behavioral Strategies |
3.83; 3.78 | — |
| PRIMARY Alcohol Protective Behavioral Strategies |
3.83; 3.78 | — |
| PRIMARY Average Days Cannabis Use Past Two Months |
4.46; 4.60 | — |
| PRIMARY Average Days Cannabis Use Past Two Months |
4.46; 4.60 | — |
| PRIMARY Cannabis Protective Behavioral Strategies |
3.56; 3.61 | — |
| PRIMARY Cannabis Protective Behavioral Strategies |
3.56; 3.61 | — |
| PRIMARY Marijuana Consequences Questionnaire |
20.76; 21.38 | — |
| PRIMARY Marijuana Consequences Questionnaire |
20.76; 21.38 | — |
| PRIMARY Simultaneous Alcohol and Marijuana Use |
.88; .83 | — |
| PRIMARY Simultaneous Alcohol and Marijuana Use |
.88; .83 | — |
| PRIMARY Feasibility- Number of Participants Who Visited the Online Intervention |
78 | — |
| PRIMARY Feasibility- Number of Online Modules Selected |
8.80 | — |
| PRIMARY Acceptability- System Usability Scale |
76.60 | — |
Summary
The most successful young adult alcohol or marijuana interventions involve the provision of accurate, nonjudgmental personalized feedback, but notably the inclusion and effectiveness of protective behavioral strategies (PBS) content is inconsistent. Moreover, active components of brief interventions are not well understood, and findings have been inconclusive regarding whether PBS mediates intervention efficacy of college student personalized feedback interventions (PFIs), with only some studies showing evidence of mediation. One possible reason for these findings is that investigators often do not know young adults' motivations for using (or not using) PBS or the quality of PBS use across individuals or across drinking occasions. The proposed study will provide an in-depth examination of which PBS young adults are motivated to use (including implementation quality) and reasons that young adults may or may not use PBS. Understanding why young adults are choosing not to use PBS on specific occasions or do not engage in effective or high-quality PBS use on certain occasions has significant clinical implications, whereby interventions may need to spend more time increasing motivations to use PBS in an effective manner or work on reducing perceived barriers (i.e., reasons individuals are not using PBS). Clinicians may then be better able to work with young adults in various settings to reduce or prevent excessive alcohol and marijuana use and related consequences. The proposed research has high potential for making a substantial impact on the field and public health (particularly as more states permit legal access to marijuana for those over 21) as it will address a problem of high importance (alcohol and marijuana use) by being the first to develop and refine a PBS intervention that specifically focuses on motivations for alcohol and marijuana PBS use and non-use as well as quality of use, which is an overlooked aspect of current PBS-related intervention approaches. The development of more efficacious interventions to reduce the proportion of young adults who engage in excessive alcohol use and who experience consequences is a key priority of the NIAAA. Related, development of more effective interventions to reduce risk from marijuana use is an area of great importance for the NIDA.
Eligibility Criteria
Inclusion Criteria
- Age 18-24
- Live in Texas
- Valid email address
- Own a cell phone with text messaging capabilities
- Okay with receiving messages
- Typically drink at least 2 days a week
- Typically use marijuana at least 2 days a week
- Report having at least 1 alcohol-related and 1 marijuana-related consequence in the past month
- Report being in contemplation or action stage based on readiness to change scale for alcohol or marijuana (i.e., not in precontemplation stage)
- If female, not pregnant or trying to become pregnant
- Not currently in treatment for alcohol or substance use
- Willing to participate in either online focus group or online cognitive interview (Phase I) or pilot study with daily morning surveys (Phase II), and willing to receive study notifications on phone (e.g., survey reminders) [Phase II]
- Their device must meet the system requirements to participate in the online focus group or cognitive interview (have iOS 8.0 or later, Android 4.0x, or later, or have another video-enabled device) [Phase I]
Exclusion Criteria
- Not meeting inclusion criteria
- Unwillingness to participate
- Failure to provide consent
- Providing inconsistent responses (e.g., age), and
- Having already participated in the study as identified by overlap or consistency in email addresses, contact information, and demographics.
Data sourced from ClinicalTrials.gov (NCT04978129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.