Health Risk BehaviorsEQUIPNCT04978129
Enhancing Quality in Protective Strategies
A study testing Online and Text Messaging Intervention in people with Health Risk Behaviors and Risk Reduction Behavior, run by University of North Texas Health Science Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Risk Behaviors, Risk Reduction Behavior
- What is being tested?
- Online and Text Messaging Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 13Show fewer
- 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]
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Texas Health Science Center
Fort Worth, Texas, 76107
About this study
Official title: Examining Motivations for and Quality of Alcohol and Marijuana Protective Behavior Strategy Use: Improving Prevention of Hazardous Young Adult Substance Use
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.
Read the detailed description
The majority of young adults who use both alcohol and marijuana do so simultaneously. Simultaneous Alcohol and Marijuana (SAM) use is defined as using alcohol and marijuana at the same time so that their effects overlap. Individuals who engage in Concurrent Alcohol and Marijuana (CAM) use are often characterized as those who report both alcohol and marijuana use within the same time period (e.g., past month, past week). An increasing body of literature has documented CAM and SAM use on a given day among young adults. Event-level findings show SAM use is associated with increased risk for consequences, compared to marijuana use alone or CAM use. Given that the investigators' focus in this application is on daily-level substance use behaviors, the investigators define CAM use as using both substances on the same day, but not so that their effects overlap. Interventions should focus on reducing drinking as well as drinking that occurs in conjunction with marijuana use to provide a more comprehensive evaluation of intervention efficacy. The proposed research in this application will develop and test a novel online and text message (TM) protective behavioral strategies (PBS) intervention to reduce alcohol, marijuana, CAM, and SAM use and related negative consequences among young adults.
One way interventions could prevent or reduce alcohol- and marijuana-related consequences is by promoting the use of PBS, which are behaviors that individuals can use to limit consequences and/or reduce substance use. PBS are often incorporated into brief interventions or TM interventions in the form of skills training. Despite the empirical support for including PBS content in brief interventions, findings have been inconclusive regarding whether PBS mediate intervention efficacy among college students. One possible explanation is that skills-based PBS interventions prematurely focus on "how" to use PBS, but not "why" PBS might be used or used with high quality. Research is needed to determine motivations for when and why young adults may or may not decide to use PBS to reduce harm while using alcohol and/or marijuana, which can then enable investigators to better address these motivations in brief interventions. Research has yet to examine how alcohol and marijuana PBS use on a given day relates to an individual's use of alcohol alone or marijuana alone in comparison to CAM or SAM use. The proposed study will fill these critical gaps by identifying the extent to which motivations for PBS use and nonuse (marijuana or alcohol) and quality of PBS use (degree of effectiveness or degree of implementation) differ when using alcohol alone versus concurrently or simultaneously with marijuana. The overall goal of this research is to inform a pilot study of a newly developed alcohol and marijuana PBS intervention. The proposed research will (1) collect pilot data to establish feasibility and acceptability and test the interactive online and TM PBS intervention (baseline, 2-month) while also (2) collecting event-level data to examine daily-level associations among PBS motivation/quality, PBS use and non-use, alcohol and/or marijuana use, and negative consequences with a focus on how PBS may differ on CAM or SAM use days compared to alcohol-only days.
Aim 1: Examine motivations for alcohol and marijuana PBS use (and non-use of PBS) as well as quality of PBS use among young adults (ages 18-24) who use both alcohol and marijuana. The present study will conduct online focus groups (10 groups, N=10 individuals per group) and cognitive interviews (N=10) to determine why young adults use or do not use specific PBS related to alcohol and/or marijuana use. Focus groups will address how PBS use or motivations to avoid consequences may differ by gender (male, female, non-binary). Focus groups and cognitive interviews will discuss the level of quality in which PBS are used and various contexts in which PBS may or may not be used. Discussions will consider use of either substance alone on a given day as well as SAM or CAM use on a given day and will include ways in which the motivations and quality of PBS could be incorporated into an online and TM PBS intervention, as well as elicit feedback on mock intervention material. Using an exploratory sequential mixed methods design, an iterative process of focus groups and cognitive interviews will inform the development and delivery of the intervention to be tested in the pilot study (Aim 2). Aim 1 is not a clinical trial.
Aim 2: Conduct a pilot study with young adults (N=200; ages 18-24), who typically use alcohol and marijuana at least two days per week, to determine feasibility, acceptability, and preliminary effect sizes (to inform a future R01 application). Participants will be randomized to either the intervention or wait-list control. The intervention is a brief interactive online intervention focusing on self-selected alcohol and marijuana PBS messages and motives for using alcohol- and marijuana-related PBS and includes intervention content delivered via TMs three days a week (random day, Friday, Saturday) over eight consecutive weekends. All participants will report PBS use, motivations for PBS use (and non-use), quality of PBS use, readiness to change, and alcohol and marijuana use in morning surveys timed to occur the day after the intervention TMs for those in the intervention group. The proposed research in this application will provide an in-depth understanding of young adults' PBS use and has potential to develop a more efficacious intervention for these co-occurring or simultaneous alcohol and marijuana behaviors. Aim 2 is the clinical trial.
- Conditions
- Health Risk Behaviors, Risk Reduction Behavior
- Being tested
- Online and Text Messaging Intervention
- Medical subject headings
- Health Risk Behaviors, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online and Text Messaging InterventionBehavioural
The online and TM intervention, and its delivery, will be designed and adapted based on the results of the formative focus groups and cognitive interviews and is meant to be non-confrontational in tone, seeks to increase motivation to increase the quality use of PBS and decrease motivations for non-use of PBS.
| Study group | Role | What they receive |
|---|---|---|
| Online and Text Message Intervention | Experimental | Participants randomized to the intervention will receive a link to the online intervention following baseline completion. The online and Text Message intervention, and its delivery, will be designed and adapted based on the results of the formative focus groups and cognitive interviews and is meant to be non-confrontational in tone, seeks to increase motivation to increase the quality use of PBS and decrease motivations for non-use of PBS. Intervention participants will receive personalized PBS Text Messages 3x per week (based on self-selections from the interactive online intervention) for 8 consecutive weeks timed to occur on a random weekday as well as Friday and Saturday. Receives: Behavioral: Online and Text Messaging Intervention |
| Assessment Only Control | No intervention | The assessment only control condition will not receive any intervention content during the 8-week period of data collection, but will complete baseline, 2-month, and daily surveys according to the same schedule as the intervention group in order to assess event-level PBS use, PBS non-use, alcohol and marijuana use, CAM and SAM use, and related consequences for up to 24 days over an 8-week period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Typical Number of Drinks Per Occasion
Measures the typical number of drinks consumed per occasion.
Measured: Baseline
Typical Number of Drinks Per Occasion
Measures the typical number of drinks consumed per occasion.
Measured: 2 Month
Young Adult Alcohol Consequences Questionnaire
The Young Adult Alcohol Consequences Questionnaire will asses consequences from drinking.
Measured: Baseline
Young Adult Alcohol Consequences Questionnaire
The Young Adult Alcohol Consequences Questionnaire will asses consequences from drinking.
Measured: 2 Month
Alcohol Protective Behavioral Strategies
Alcohol Protective Behavioral Strategies (i.e., tips and strategies used to reduce harm when drinking) will be assessed with the Protective Behavioral Strategies Survey-20. Protective Behavioral Strategies were assessed using the full Protective Behavioral Strategies Scale-20 (PBSS-20), which measures the frequency of using strategies to limit alcohol use and related consequences. The PBSS-20 consists of 20 items rated on a 6-point Likert-type scale (1 = Never to 6 = Always). Scores are averaged across items, with higher values indicating greater use of protective behavioral strategies (i.e., a more favorable outcome).
Measured: Baseline
Alcohol Protective Behavioral Strategies
Alcohol Protective Behavioral Strategies (i.e., tips and strategies used to reduce harm when drinking) will be assessed with the Protective Behavioral Strategies Survey-20. Protective Behavioral Strategies were assessed using the full Protective Behavioral Strategies Scale-20 (PBSS-20), which measures the frequency of using strategies to limit alcohol use and related consequences. The PBSS-20 consists of 20 items rated on a 6-point Likert-type scale (1 = Never to 6 = Always). Scores are averaged across items, with higher values indicating greater use of protective behavioral strategies (i.e., a more favorable outcome).
Measured: 2 Month
Average Days Cannabis Use Past Two Months
This measure will assess typical days cannabis was used the past two months.
Measured: Baseline
Average Days Cannabis Use Past Two Months
This measure will assess typical days cannabis was used the past two months.
Measured: 2 Month
Cannabis Protective Behavioral Strategies
Cannabis Protective Behavioral Strategies were assessed using the Protective Behavioral Strategies for Marijuana Scale, a 26-item measure evaluating the frequency of strategies used to reduce cannabis use and related harm. Items are rated on a 6-point Likert scale (1 = Never to 6 = Always). Scores are averaged across items, with higher scores indicating greater use of protective behavioral strategies (i.e., a more favorable outcome).
Measured: Baseline
Cannabis Protective Behavioral Strategies
Cannabis Protective Behavioral Strategies were assessed using the Protective Behavioral Strategies for Marijuana Scale, a 26-item measure evaluating the frequency of strategies used to reduce cannabis use and related harm. Items are rated on a 6-point Likert scale (1 = Never to 6 = Always). Scores are averaged across items, with higher scores indicating greater use of protective behavioral strategies (i.e., a more favorable outcome).
Measured: 2 Month
Marijuana Consequences Questionnaire
The Marijuana Consequences Questionnaire and a modified version will measure a broad range of negative cannabis consequences.
Measured: Baseline
Marijuana Consequences Questionnaire
The Marijuana Consequences Questionnaire and a modified version will measure a broad range of negative cannabis consequences.
Measured: 2 Month
Simultaneous Alcohol and Marijuana Use
Questions regarding SAM use will be adapted from MTF.
Measured: Baseline
Simultaneous Alcohol and Marijuana Use
Questions regarding SAM use will be adapted from MTF.
Measured: 2 Month
Feasibility- Number of Participants Who Visited the Online Intervention
The Number of Participants who Visited the Online Intervention
Measured: 2 Month
Feasibility- Number of Online Modules Selected
The number of modules participants in the intervention condition selected to view.
Measured: Baseline
Acceptability- System Usability Scale
Scores on a measure of subjective assessments of usability (SUS) from participants in the intervention condition. Total score from 0 to 100 with higher scores indicating higher usability.
Measured: Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start15 Aug 2023
- Primary completion1 Nov 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Health Risk BehaviorsStudies 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
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Melissa Lewis, PhD, The University of Texas at Arlington
- Investigators
- Melissa A Lewis, PhD, Principal investigator, University of North Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978129
- Sponsor's protocol ID
- 7R34AA028730-04
- Other IDs
- 7R34AA028730-04
- Acronym
- EQUIP
- Status last verified
- Nov 2025
- First submitted
- 24 Jun 2021
- Last updated
- 3 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A select number of researchers will have access to unidentified participant data at the close of the study.
Publications
National Institute on Alcohol Abuse and Alcoholism (2019). Planning alcohol interventions using NIAAA's College Alcohol Intervention Matrix (CollegeAIM). Bethesda, MD: National Institutes of Health, (NIH Publication No. 19-AA-8017, Updated December 2019).
Miller, W. R., & Rollnick, S. (2013). Motivational interviewing: Helping people change (3rd ed.). New York, NY: Guilford Press.
Gaume J, McCambridge J, Bertholet N, Daeppen JB. Mechanisms of action of brief alcohol interventions remain largely unknown - a narrative review. Front Psychiatry. 2014 Aug 26;5:108. doi: 10.3389/fpsyt.2014.00108. eCollection 2014.
PubMed 25206342Reid AE, Carey KB. Interventions to reduce college student drinking: State of the evidence for mechanisms of behavior change. Clin Psychol Rev. 2015 Aug;40:213-24. doi: 10.1016/j.cpr.2015.06.006. Epub 2015 Jun 24.
PubMed 26164065Subbaraman MS, Kerr WC. Simultaneous versus concurrent use of alcohol and cannabis in the National Alcohol Survey. Alcohol Clin Exp Res. 2015 May;39(5):872-9. doi: 10.1111/acer.12698.
PubMed 25872596Egan KL, Cox MJ, Suerken CK, Reboussin BA, Song EY, Wagoner KG, Wolfson M. More drugs, more problems? Simultaneous use of alcohol and marijuana at parties among youth and young adults. Drug Alcohol Depend. 2019 Sep 1;202:69-75. doi: 10.1016/j.drugalcdep.2019.07.003. Epub 2019 Jul 6.
PubMed 31319362Lipperman-Kreda S, Gruenewald PJ, Grube JW, Bersamin M. Adolescents, alcohol, and marijuana: Context characteristics and problems associated with simultaneous use. Drug Alcohol Depend. 2017 Oct 1;179:55-60. doi: 10.1016/j.drugalcdep.2017.06.023. Epub 2017 Jul 20.
PubMed 28755540Martens MP, Taylor KK, Damann KM, Page JC, Mowry ES, Cimini MD. Protective behavioral strategies when drinking alcohol and their relationship to negative alcohol-related consequences in college students. Psychol Addict Behav. 2004 Dec;18(4):390-3. doi: 10.1037/0893-164X.18.4.390.
PubMed 15631613Pedersen ER, Hummer JF, Rinker DV, Traylor ZK, Neighbors C. Measuring Protective Behavioral Strategies for Marijuana Use Among Young Adults. J Stud Alcohol Drugs. 2016 May;77(3):441-50. doi: 10.15288/jsad.2016.77.441.
PubMed 27172576Murphy JG, Dennhardt AA, Skidmore JR, Borsari B, Barnett NP, Colby SM, Martens MP. A randomized controlled trial of a behavioral economic supplement to brief motivational interventions for college drinking. J Consult Clin Psychol. 2012 Oct;80(5):876-86. doi: 10.1037/a0028763. Epub 2012 Jun 4.
PubMed 22663899Riggs NR, Conner BT, Parnes JE, Prince MA, Shillington AM, George MW. Marijuana eCHECKUPTO GO: Effects of a personalized feedback plus protective behavioral strategies intervention for heavy marijuana-using college students. Drug Alcohol Depend. 2018 Sep 1;190:13-19. doi: 10.1016/j.drugalcdep.2018.05.020. Epub 2018 Jun 23.
PubMed 29960918Cadigan JM, Martens MP, Dworkin ER, Sher KJ. The Efficacy of an Event-Specific, Text Message, Personalized Drinking Feedback Intervention. Prev Sci. 2019 Aug;20(6):873-883. doi: 10.1007/s11121-018-0939-9.
PubMed 30054777Lewis MA, Cadigan JM, Cronce JM, Kilmer JR, Suffoletto B, Walter T, Lee CM. Developing Text Messages to Reduce Community College Student Alcohol Use. Am J Health Behav. 2018 Jul 1;42(4):70-79. doi: 10.5993/AJHB.42.4.7.
PubMed 29973312Miller MB, Leffingwell T, Claborn K, Meier E, Walters S, Neighbors C. Personalized feedback interventions for college alcohol misuse: an update of Walters & Neighbors (2005). Psychol Addict Behav. 2013 Dec;27(4):909-20. doi: 10.1037/a0031174. Epub 2012 Dec 31.
PubMed 23276309Collins RL, Parks GA, Marlatt GA. Social determinants of alcohol consumption: the effects of social interaction and model status on the self-administration of alcohol. J Consult Clin Psychol. 1985 Apr;53(2):189-200. doi: 10.1037//0022-006x.53.2.189. No abstract available.
PubMed 3998247
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Motivations for and Quality of Alcohol and Marijuana Protective Behavior Strategy Use: Improving Prevention of Hazardous Young Adult Substance Use
- ClinicalTrials.gov ID
- NCT04978129
- Acronym / sponsor ID
- EQUIP / 7R34AA028730-04
- Conditions
- Health Risk Behaviors, Risk Reduction Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Posted 3 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The majority of young adults who use both alcohol and marijuana do so simultaneously. Simultaneous Alcohol and Marijuana (SAM) use is defined as using alcohol and marijuana at the same time so that their effects overlap. Individuals who engage in Concurrent Alcohol and Marijuana (CAM) use are often characterized as those who report both alcohol and marijuana use within the same time period (e.g., past month, past week). An increasing body of literature has documented CAM and SAM use on a given day among young adults. Event-level findings show SAM use is associated with increased risk for consequences, compared to marijuana use alone or CAM use. Given that the investigators' focus in this application is on daily-level substance use behaviors, the investigators define CAM use as using both substances on the same day, but not so that their effects overlap. Interventions should focus on reducing drinking as well as drinking that occurs in conjunction with marijuana use to provide a more comprehensive evaluation of intervention efficacy. The proposed research in this application will develop and test a novel online and text message (TM) protective behavioral strategies (PBS) intervention to reduce alcohol, marijuana, CAM, and SAM use and related negative consequences among young adults.
One way interventions could prevent or reduce alcohol- and marijuana-related consequences is by promoting the use of PBS, which are behaviors that individuals can use to limit consequences and/or reduce substance use. PBS are often incorporated into brief interventions or TM interventions in the form of skills training. Despite the empirical support for including PBS content in brief interventions, findings have been inconclusive regarding whether PBS mediate intervention efficacy among college students. One possible explanation is that skills-based PBS interventions prematurely focus on "how" to use PBS, but not "why" PBS might be used or used with high quality. Research is needed to determine motivations for when and why young adults may or may not decide to use PBS to reduce harm while using alcohol and/or marijuana, which can then enable investigators to better address these motivations in brief interventions. Research has yet to examine how alcohol and marijuana PBS use on a given day relates to an individual's use of alcohol alone or marijuana alone in comparison to CAM or SAM use. The proposed study will fill these critical gaps by identifying the extent to which motivations for PBS use and nonuse (marijuana or alcohol) and quality of PBS use (degree of effectiveness or degree of implementation) differ when using alcohol alone versus concurrently or simultaneously with marijuana. The overall goal of this research is to inform a pilot study of a newly developed alcohol and marijuana PBS intervention. The proposed research will (1) collect pilot data to establish feasibility and acceptability and test the interactive online and TM PBS intervention (baseline, 2-month) while also (2) collecting event-level data to examine daily-level associations among PBS motivation/quality, PBS use and non-use, alcohol and/or marijuana use, and negative consequences with a focus on how PBS may differ on CAM or SAM use days compared to alcohol-only days.
Aim 1: Examine motivations for alcohol and marijuana PBS use (and non-use of PBS) as well as quality of PBS use among young adults (ages 18-24) who use both alcohol and marijuana. The present study will conduct online focus groups (10 groups, N=10 individuals per group) and cognitive interviews (N=10) to determine why young adults use or do not use specific PBS related to alcohol and/or marijuana use. Focus groups will address how PBS use or motivations to avoid consequences may differ by gender (male, female, non-binary). Focus groups and cognitive interviews will discuss the level of quality in which PBS are used and various contexts in which PBS may or may not be used. Discussions will consider use of either substance alone on a given day as well as SAM or CAM use on a given day and will include ways in which the motivations and quality of PBS could be incorporated into an online and TM PBS intervention, as well as elicit feedback on mock intervention material. Using an exploratory sequential mixed methods design, an iterative process of focus groups and cognitive interviews will inform the development and delivery of the intervention to be tested in the pilot study (Aim 2). Aim 1 is not a clinical trial.
Aim 2: Conduct a pilot study with young adults (N=200; ages 18-24), who typically use alcohol and marijuana at least two days per week, to determine feasibility, acceptability, and preliminary effect sizes (to inform a future R01 application). Participants will be randomized to either the intervention or wait-list control. The intervention is a brief interactive online intervention focusing on self-selected alcohol and marijuana PBS messages and motives for using alcohol- and marijuana-related PBS and includes intervention content delivered via TMs three days a week (random day, Friday, Saturday) over eight consecutive weekends. All participants will report PBS use, motivations for PBS use (and non-use), quality of PBS use, readiness to change, and alcohol and marijuana use in morning surveys timed to occur the day after the intervention TMs for those in the intervention group. The proposed research in this application will provide an in-depth understanding of young adults' PBS use and has potential to develop a more efficacious intervention for these co-occurring or simultaneous alcohol and marijuana behaviors. Aim 2 is the clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online and Text Message Intervention | Experimental | Behavioral: Online and Text Messaging InterventionParticipants randomized to the intervention will receive a link to the online intervention following baseline completion. The online and Text Message intervention, and its delivery, will be designed and adapted based on the results of the formative focus groups and cognitive interviews and is meant to be non-confrontational in tone, seeks to increase motivation to increase the quality use of PBS and decrease motivations for non-use of PBS. Intervention participants will receive personalized PBS Text Messages 3x per week (based on self-selections from the interactive online intervention) for 8 consecutive weeks timed to occur on a random weekday as well as Friday and Saturday. |
| Assessment Only Control | No intervention | –The assessment only control condition will not receive any intervention content during the 8-week period of data collection, but will complete baseline, 2-month, and daily surveys according to the same schedule as the intervention group in order to assess event-level PBS use, PBS non-use, alcohol and marijuana use, CAM and SAM use, and related consequences for up to 24 days over an 8-week period. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Age 18-24
- Live in Texas
- Valid email address
- Own a cell phone with text messaging capabilities
- Okay with receiving messages
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Online and Text Messaging InterventionThe online and TM intervention, and its delivery, will be designed and adapted based on the results of the formative focus groups and cognitive interviews and is meant to be non-confrontational in tone, seeks to increase motivation to increase the quality use of PBS and decrease motivations for non-use of PBS. | Behavioural | Online and Text Message Intervention |
Primary outcome
Typical Number of Drinks Per Occasion
Time frame: Baseline
Measures the typical number of drinks consumed per occasion.
Typical Number of Drinks Per Occasion
Time frame: 2 Month
Measures the typical number of drinks consumed per occasion.
Young Adult Alcohol Consequences Questionnaire
Time frame: Baseline
The Young Adult Alcohol Consequences Questionnaire will asses consequences from drinking.
Young Adult Alcohol Consequences Questionnaire
Time frame: 2 Month
The Young Adult Alcohol Consequences Questionnaire will asses consequences from drinking.
Alcohol Protective Behavioral Strategies
Time frame: Baseline
Alcohol Protective Behavioral Strategies (i.e., tips and strategies used to reduce harm when drinking) will be assessed with the Protective Behavioral Strategies Survey-20. Protective Behavioral Strategies were assessed using the full Protective Behavioral Strategies Scale-20 (PBSS-20), which measures the frequency of using strategies to limit alcohol use and related consequences. The PBSS-20 consists of 20 items rated on a 6-point Likert-type scale (1 = Never to 6 = Always). Scores are averaged across items, with higher values indicating greater use of protective behavioral strategies (i.e., a more favorable outcome).
Alcohol Protective Behavioral Strategies
Time frame: 2 Month
Alcohol Protective Behavioral Strategies (i.e., tips and strategies used to reduce harm when drinking) will be assessed with the Protective Behavioral Strategies Survey-20. Protective Behavioral Strategies were assessed using the full Protective Behavioral Strategies Scale-20 (PBSS-20), which measures the frequency of using strategies to limit alcohol use and related consequences. The PBSS-20 consists of 20 items rated on a 6-point Likert-type scale (1 = Never to 6 = Always). Scores are averaged across items, with higher values indicating greater use of protective behavioral strategies (i.e., a more favorable outcome).
Average Days Cannabis Use Past Two Months
Time frame: Baseline
This measure will assess typical days cannabis was used the past two months.
Average Days Cannabis Use Past Two Months
Time frame: 2 Month
This measure will assess typical days cannabis was used the past two months.
Cannabis Protective Behavioral Strategies
Time frame: Baseline
Cannabis Protective Behavioral Strategies were assessed using the Protective Behavioral Strategies for Marijuana Scale, a 26-item measure evaluating the frequency of strategies used to reduce cannabis use and related harm. Items are rated on a 6-point Likert scale (1 = Never to 6 = Always). Scores are averaged across items, with higher scores indicating greater use of protective behavioral strategies (i.e., a more favorable outcome).
Cannabis Protective Behavioral Strategies
Time frame: 2 Month
Cannabis Protective Behavioral Strategies were assessed using the Protective Behavioral Strategies for Marijuana Scale, a 26-item measure evaluating the frequency of strategies used to reduce cannabis use and related harm. Items are rated on a 6-point Likert scale (1 = Never to 6 = Always). Scores are averaged across items, with higher scores indicating greater use of protective behavioral strategies (i.e., a more favorable outcome).
Marijuana Consequences Questionnaire
Time frame: Baseline
The Marijuana Consequences Questionnaire and a modified version will measure a broad range of negative cannabis consequences.
Marijuana Consequences Questionnaire
Time frame: 2 Month
The Marijuana Consequences Questionnaire and a modified version will measure a broad range of negative cannabis consequences.
Simultaneous Alcohol and Marijuana Use
Time frame: Baseline
Questions regarding SAM use will be adapted from MTF.
Simultaneous Alcohol and Marijuana Use
Time frame: 2 Month
Questions regarding SAM use will be adapted from MTF.
Feasibility- Number of Participants Who Visited the Online Intervention
Time frame: 2 Month
The Number of Participants who Visited the Online Intervention
Feasibility- Number of Online Modules Selected
Time frame: Baseline
The number of modules participants in the intervention condition selected to view.
Acceptability- System Usability Scale
Time frame: Post-Intervention
Scores on a measure of subjective assessments of usability (SUS) from participants in the intervention condition. Total score from 0 to 100 with higher scores indicating higher usability.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundNational Institute on Alcohol Abuse and Alcoholism (2019). Planning alcohol interventions using NIAAA's College Alcohol Intervention Matrix (CollegeAIM). Bethesda, MD: National Institutes of Health, (NIH Publication No. 19-AA-8017, Updated December 2019).
- BackgroundMiller, W. R., & Rollnick, S. (2013). Motivational interviewing: Helping people change (3rd ed.). New York, NY: Guilford Press.
- Background: PubMed 25206342Gaume J, McCambridge J, Bertholet N, Daeppen JB. Mechanisms of action of brief alcohol interventions remain largely unknown - a narrative review. Front Psychiatry. 2014 Aug 26;5:108. doi: 10.3389/fpsyt.2014.00108. eCollection 2014.
- Background: PubMed 26164065Reid AE, Carey KB. Interventions to reduce college student drinking: State of the evidence for mechanisms of behavior change. Clin Psychol Rev. 2015 Aug;40:213-24. doi: 10.1016/j.cpr.2015.06.006. Epub 2015 Jun 24.
- Background: PubMed 25872596Subbaraman MS, Kerr WC. Simultaneous versus concurrent use of alcohol and cannabis in the National Alcohol Survey. Alcohol Clin Exp Res. 2015 May;39(5):872-9. doi: 10.1111/acer.12698.
- Background: PubMed 31319362Egan KL, Cox MJ, Suerken CK, Reboussin BA, Song EY, Wagoner KG, Wolfson M. More drugs, more problems? Simultaneous use of alcohol and marijuana at parties among youth and young adults. Drug Alcohol Depend. 2019 Sep 1;202:69-75. doi: 10.1016/j.drugalcdep.2019.07.003. Epub 2019 Jul 6.
- Background: PubMed 28755540Lipperman-Kreda S, Gruenewald PJ, Grube JW, Bersamin M. Adolescents, alcohol, and marijuana: Context characteristics and problems associated with simultaneous use. Drug Alcohol Depend. 2017 Oct 1;179:55-60. doi: 10.1016/j.drugalcdep.2017.06.023. Epub 2017 Jul 20.
- Background: PubMed 15631613Martens MP, Taylor KK, Damann KM, Page JC, Mowry ES, Cimini MD. Protective behavioral strategies when drinking alcohol and their relationship to negative alcohol-related consequences in college students. Psychol Addict Behav. 2004 Dec;18(4):390-3. doi: 10.1037/0893-164X.18.4.390.
- Background: PubMed 27172576Pedersen ER, Hummer JF, Rinker DV, Traylor ZK, Neighbors C. Measuring Protective Behavioral Strategies for Marijuana Use Among Young Adults. J Stud Alcohol Drugs. 2016 May;77(3):441-50. doi: 10.15288/jsad.2016.77.441.
- Background: PubMed 22663899Murphy JG, Dennhardt AA, Skidmore JR, Borsari B, Barnett NP, Colby SM, Martens MP. A randomized controlled trial of a behavioral economic supplement to brief motivational interventions for college drinking. J Consult Clin Psychol. 2012 Oct;80(5):876-86. doi: 10.1037/a0028763. Epub 2012 Jun 4.
- Background: PubMed 29960918Riggs NR, Conner BT, Parnes JE, Prince MA, Shillington AM, George MW. Marijuana eCHECKUPTO GO: Effects of a personalized feedback plus protective behavioral strategies intervention for heavy marijuana-using college students. Drug Alcohol Depend. 2018 Sep 1;190:13-19. doi: 10.1016/j.drugalcdep.2018.05.020. Epub 2018 Jun 23.
- Background: PubMed 30054777Cadigan JM, Martens MP, Dworkin ER, Sher KJ. The Efficacy of an Event-Specific, Text Message, Personalized Drinking Feedback Intervention. Prev Sci. 2019 Aug;20(6):873-883. doi: 10.1007/s11121-018-0939-9.
- Individual participant dataSharing planned: No. A select number of researchers will have access to unidentified participant data at the close of the study.
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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.
Melissa A Lewis, PhD principal investigator
University of North Texas Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online and Text Messaging Intervention in people with Health Risk Behaviors and Risk Reduction Behavior, run by University of North Texas Health Science Center 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 13 inclusion and 5 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 3 Dec 2025. 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?
Yes. Results are posted in the registry (first posted 3 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Typical Number of Drinks Per Occasion (time frame: Baseline). The study lists 17 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 NCT04978129, which also lists 42 linked publications.
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 3 Dec 2025.