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Enhancing Quality in Protective Strategies

Examining Motivations for and Quality of Alcohol and Marijuana Protective Behavior Strategy Use: Improving Prevention of Hazardous Young Adult Substance Use

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04978129
Acronym
EQUIP
Enrollment
162
Registered
2021-07-27
Start date
2023-08-15
Completion date
2025-04-01
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Risk Behaviors, Risk Reduction Behavior

Brief 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.

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.

Interventions

BEHAVIORALOnline and Text Messaging Intervention

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.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of North Texas Health Science Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age 18-24 2. Live in Texas 3. Valid email address 4. Own a cell phone with text messaging capabilities 5. Okay with receiving messages 6. Typically drink at least 2 days a week 7. Typically use marijuana at least 2 days a week 8. Report having at least 1 alcohol-related and 1 marijuana-related consequence in the past month 9. Report being in contemplation or action stage based on readiness to change scale for alcohol or marijuana (i.e., not in precontemplation stage) 10. If female, not pregnant or trying to become pregnant 11. Not currently in treatment for alcohol or substance use 12. 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) \[Phase II\] 13. 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

1. Not meeting inclusion criteria 2. Unwillingness to participate 3. Failure to provide consent 4. Providing inconsistent responses (e.g., age), and 5. Having already participated in the study as identified by overlap or consistency in email addresses, contact information, and demographics.

Design outcomes

Primary

MeasureTime frameDescription
Typical Number of Drinks Per OccasionBaselineMeasures the typical number of drinks consumed per occasion.
Young Adult Alcohol Consequences QuestionnaireBaselineThe Young Adult Alcohol Consequences Questionnaire will asses consequences from drinking.
Alcohol Protective Behavioral StrategiesBaselineAlcohol 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 MonthsBaselineThis measure will assess typical days cannabis was used the past two months.
Cannabis Protective Behavioral StrategiesBaselineCannabis 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 QuestionnaireBaselineThe Marijuana Consequences Questionnaire and a modified version will measure a broad range of negative cannabis consequences.
Simultaneous Alcohol and Marijuana UseBaselineQuestions regarding SAM use will be adapted from MTF.
Feasibility- Number of Participants Who Visited the Online Intervention2 MonthThe Number of Participants who Visited the Online Intervention
Feasibility- Number of Online Modules SelectedBaselineThe number of modules participants in the intervention condition selected to view.
Acceptability- System Usability ScalePost-InterventionScores 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.

Countries

United States

Participant flow

Recruitment details

Participants were recruited from Texas state using a variety of recruitment methods. Individuals were invited to complete an online eligibility survey for participation in a randomized clinical trial to test the effect of an online and text message personalized feedback intervention. Recruitment/enrollment and data collection period went from August 2023 to October 2024.

Participants by arm

ArmCount
Online and Text Message Intervention
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.
83
Assessment Only Control
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.
79
Total162

Baseline characteristics

CharacteristicOnline and Text Message InterventionTotalAssessment Only Control
Age, Continuous22.18 Years22.09 Years22 Years
Current Student45 Participants86 Participants41 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
32 Participants62 Participants30 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
51 Participants100 Participants49 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
4 Participants9 Participants5 Participants
Race (NIH/OMB)
Asian
8 Participants16 Participants8 Participants
Race (NIH/OMB)
Black or African American
18 Participants37 Participants19 Participants
Race (NIH/OMB)
More than one race
5 Participants10 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
48 Participants90 Participants42 Participants
Sex: Female, Male
Female
53 Participants104 Participants51 Participants
Sex: Female, Male
Male
30 Participants58 Participants28 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 830 / 79
other
Total, other adverse events
0 / 830 / 79
serious
Total, serious adverse events
0 / 830 / 79

Outcome results

Primary

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.

Time frame: Post-Intervention

Population: The number of participants represents those who provided data for this outcome measure. Only the intervention group completed this measure. The control group did not receive this measure.

ArmMeasureValue (MEAN)Dispersion
Online and Text Message InterventionAcceptability- System Usability Scale76.60 Mean SUS scoreStandard Deviation 13.2
Primary

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).

Time frame: 2 Month

Population: The number of participants represents those who provided data for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Online and Text Message InterventionAlcohol Protective Behavioral Strategies3.83 Units on a 1-6 scaleStandard Deviation 0.878
Assessment Only ControlAlcohol Protective Behavioral Strategies3.78 Units on a 1-6 scaleStandard Deviation 1.059
Primary

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).

Time frame: Baseline

Population: The number of participants represents those who provided data for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Online and Text Message InterventionAlcohol Protective Behavioral Strategies3.67 Units on a 1-6 scaleStandard Deviation 0.706
Assessment Only ControlAlcohol Protective Behavioral Strategies3.63 Units on a 1-6 scaleStandard Deviation 0.867
Primary

Average Days Cannabis Use Past Two Months

This measure will assess typical days cannabis was used the past two months.

Time frame: 2 Month

Population: The number of participants represents those who provided data for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Online and Text Message InterventionAverage Days Cannabis Use Past Two Months4.46 Average days cannabis use past two monthStandard Deviation 3.42
Assessment Only ControlAverage Days Cannabis Use Past Two Months4.60 Average days cannabis use past two monthStandard Deviation 3.06
Primary

Average Days Cannabis Use Past Two Months

This measure will assess typical days cannabis was used the past two months.

Time frame: Baseline

Population: The number of participants represents those who provided data for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Online and Text Message InterventionAverage Days Cannabis Use Past Two Months5.74 Average days cannabis use past two monthStandard Deviation 3.01
Assessment Only ControlAverage Days Cannabis Use Past Two Months6.09 Average days cannabis use past two monthStandard Deviation 3.15
Primary

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).

Time frame: Baseline

Population: The number of participants represents those who provided data for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Online and Text Message InterventionCannabis Protective Behavioral Strategies3.20 Units on a 1-6 scaleStandard Deviation 0.677
Assessment Only ControlCannabis Protective Behavioral Strategies3.22 Units on a 1-6 scaleStandard Deviation 0.985
Primary

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).

Time frame: 2 Month

Population: The number of participants represents those who provided data for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Online and Text Message InterventionCannabis Protective Behavioral Strategies3.56 Units on a 1-6 scaleStandard Deviation 1.03
Assessment Only ControlCannabis Protective Behavioral Strategies3.61 Units on a 1-6 scaleStandard Deviation 1.23
Primary

Feasibility- Number of Online Modules Selected

The number of modules participants in the intervention condition selected to view.

Time frame: Baseline

Population: The number of participants represents those who provided data for this outcome measure. Only the intervention group completed this measure.

ArmMeasureValue (MEAN)Dispersion
Online and Text Message InterventionFeasibility- Number of Online Modules Selected8.80 Mean modules selectedStandard Deviation 2.8
Primary

Feasibility- Number of Participants Who Visited the Online Intervention

The Number of Participants who Visited the Online Intervention

Time frame: 2 Month

Population: The number of participants represents those who provided data for this outcome measure. Only the intervention group was assessed.

ArmMeasureValue (NUMBER)
Online and Text Message InterventionFeasibility- Number of Participants Who Visited the Online Intervention78 Participants
Primary

Marijuana Consequences Questionnaire

The Marijuana Consequences Questionnaire and a modified version will measure a broad range of negative cannabis consequences.

Time frame: Baseline

Population: The number of participants represents those who provided data for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Online and Text Message InterventionMarijuana Consequences Questionnaire28.16 Number of cannabis consequencesStandard Deviation 16.41
Assessment Only ControlMarijuana Consequences Questionnaire28.83 Number of cannabis consequencesStandard Deviation 20.73
Primary

Marijuana Consequences Questionnaire

The Marijuana Consequences Questionnaire and a modified version will measure a broad range of negative cannabis consequences.

Time frame: 2 Month

Population: The number of participants represents those who provided data for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Online and Text Message InterventionMarijuana Consequences Questionnaire20.76 Number of cannabis consequencesStandard Deviation 20.34
Assessment Only ControlMarijuana Consequences Questionnaire21.38 Number of cannabis consequencesStandard Deviation 18.2
Primary

Simultaneous Alcohol and Marijuana Use

Questions regarding SAM use will be adapted from MTF.

Time frame: 2 Month

Population: The number of participants represents those who provided data for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Online and Text Message InterventionSimultaneous Alcohol and Marijuana Use.88 Number of times SAM use past two monthsStandard Deviation 0.332
Assessment Only ControlSimultaneous Alcohol and Marijuana Use.83 Number of times SAM use past two monthsStandard Deviation 0.377
Primary

Simultaneous Alcohol and Marijuana Use

Questions regarding SAM use will be adapted from MTF.

Time frame: Baseline

Population: The number of participants represents those who provided data for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Online and Text Message InterventionSimultaneous Alcohol and Marijuana Use.93 Number of times SAM use past two monthsStandard Deviation 0.251
Assessment Only ControlSimultaneous Alcohol and Marijuana Use.93 Number of times SAM use past two monthsStandard Deviation 0.25
Primary

Typical Number of Drinks Per Occasion

Measures the typical number of drinks consumed per occasion.

Time frame: 2 Month

Population: The number of participants represents those who provided data for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Online and Text Message InterventionTypical Number of Drinks Per Occasion2.85 Typical number of drinks per occasionStandard Deviation 2.396
Assessment Only ControlTypical Number of Drinks Per Occasion3.05 Typical number of drinks per occasionStandard Deviation 3.027
Primary

Typical Number of Drinks Per Occasion

Measures the typical number of drinks consumed per occasion.

Time frame: Baseline

Population: The number of participants represents those who provided data for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Online and Text Message InterventionTypical Number of Drinks Per Occasion3.75 Typical number of drinks per occasionStandard Deviation 2.857
Assessment Only ControlTypical Number of Drinks Per Occasion3.67 Typical number of drinks per occasionStandard Deviation 3.027
Primary

Young Adult Alcohol Consequences Questionnaire

The Young Adult Alcohol Consequences Questionnaire will asses consequences from drinking.

Time frame: Baseline

Population: The number of participants represents those who provided data for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Online and Text Message InterventionYoung Adult Alcohol Consequences Questionnaire9.66 Number of ConsequencesStandard Deviation 5.92
Assessment Only ControlYoung Adult Alcohol Consequences Questionnaire8.80 Number of ConsequencesStandard Deviation 6.37
Primary

Young Adult Alcohol Consequences Questionnaire

The Young Adult Alcohol Consequences Questionnaire will asses consequences from drinking.

Time frame: 2 Month

Population: The number of participants represents those who provided data for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Online and Text Message InterventionYoung Adult Alcohol Consequences Questionnaire5.97 Number of ConsequencesStandard Deviation 6.07
Assessment Only ControlYoung Adult Alcohol Consequences Questionnaire5.78 Number of ConsequencesStandard Deviation 6.37

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026