Trial Outcomes & Findings for Enhancing Quality in Protective Strategies (NCT NCT04978129)

NCT ID: NCT04978129

Last Updated: 2025-12-03

Results Overview

Measures the typical number of drinks consumed per occasion.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 162 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2025-12-03

Participant Flow

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	83	79
Overall Study COMPLETED	78	75
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enhancing Quality in Protective Strategies

Baseline characteristics by cohort

Measure	Online and Text Message Intervention n=83 Participants 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.	Assessment Only Control n=79 Participants 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.	Total n=162 Participants Total of all reporting groups
Age, Continuous	22.18 Years n=3 Participants	22 Years n=3 Participants	22.09 Years n=6 Participants
Sex: Female, Male Female	53 Participants n=3 Participants	51 Participants n=3 Participants	104 Participants n=6 Participants
Sex: Female, Male Male	30 Participants n=3 Participants	28 Participants n=3 Participants	58 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=3 Participants	5 Participants n=3 Participants	9 Participants n=6 Participants
Race (NIH/OMB) Asian	8 Participants n=3 Participants	8 Participants n=3 Participants	16 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	18 Participants n=3 Participants	19 Participants n=3 Participants	37 Participants n=6 Participants
Race (NIH/OMB) White	48 Participants n=3 Participants	42 Participants n=3 Participants	90 Participants n=6 Participants
Race (NIH/OMB) More than one race	5 Participants n=3 Participants	5 Participants n=3 Participants	10 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants n=3 Participants	30 Participants n=3 Participants	62 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=3 Participants	49 Participants n=3 Participants	100 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Current Student	45 Participants n=3 Participants	41 Participants n=3 Participants	86 Participants n=6 Participants

PRIMARY outcome

Timeframe: Baseline

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

Measures the typical number of drinks consumed per occasion.

Outcome measures

Measure	Online and Text Message Intervention n=77 Participants 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.	Assessment Only Control n=75 Participants 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.
Typical Number of Drinks Per Occasion	3.75 Typical number of drinks per occasion Standard Deviation 2.857	3.67 Typical number of drinks per occasion Standard Deviation 3.027

PRIMARY outcome

Timeframe: 2 Month

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

Measures the typical number of drinks consumed per occasion.

Outcome measures

Measure	Online and Text Message Intervention n=72 Participants 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.	Assessment Only Control n=73 Participants 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.
Typical Number of Drinks Per Occasion	2.85 Typical number of drinks per occasion Standard Deviation 2.396	3.05 Typical number of drinks per occasion Standard Deviation 3.027

PRIMARY outcome

Timeframe: Baseline

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

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

Outcome measures

Measure	Online and Text Message Intervention n=77 Participants 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.	Assessment Only Control n=75 Participants 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.
Young Adult Alcohol Consequences Questionnaire	9.66 Number of Consequences Standard Deviation 5.92	8.80 Number of Consequences Standard Deviation 6.37

PRIMARY outcome

Timeframe: 2 Month

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

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

Outcome measures

Measure	Online and Text Message Intervention n=73 Participants 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.	Assessment Only Control n=72 Participants 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.
Young Adult Alcohol Consequences Questionnaire	5.97 Number of Consequences Standard Deviation 6.07	5.78 Number of Consequences Standard Deviation 6.37

PRIMARY outcome

Timeframe: Baseline

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

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).

Outcome measures

Measure	Online and Text Message Intervention n=75 Participants 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.	Assessment Only Control n=74 Participants 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.
Alcohol Protective Behavioral Strategies	3.67 Units on a 1-6 scale Standard Deviation .706	3.63 Units on a 1-6 scale Standard Deviation .867

PRIMARY outcome

Timeframe: 2 Month

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

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).

Outcome measures

Measure	Online and Text Message Intervention n=72 Participants 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.	Assessment Only Control n=71 Participants 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.
Alcohol Protective Behavioral Strategies	3.83 Units on a 1-6 scale Standard Deviation .878	3.78 Units on a 1-6 scale Standard Deviation 1.059

PRIMARY outcome

Timeframe: Baseline

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

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

Outcome measures

Measure	Online and Text Message Intervention n=76 Participants 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.	Assessment Only Control n=75 Participants 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.
Average Days Cannabis Use Past Two Months	5.74 Average days cannabis use past two month Standard Deviation 3.01	6.09 Average days cannabis use past two month Standard Deviation 3.15

PRIMARY outcome

Timeframe: 2 Month

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

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

Outcome measures

Measure	Online and Text Message Intervention n=72 Participants 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.	Assessment Only Control n=73 Participants 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.
Average Days Cannabis Use Past Two Months	4.46 Average days cannabis use past two month Standard Deviation 3.42	4.60 Average days cannabis use past two month Standard Deviation 3.06

PRIMARY outcome

Timeframe: Baseline

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

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).

Outcome measures

Measure	Online and Text Message Intervention n=75 Participants 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.	Assessment Only Control n=74 Participants 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.
Cannabis Protective Behavioral Strategies	3.20 Units on a 1-6 scale Standard Deviation .677	3.22 Units on a 1-6 scale Standard Deviation .985

PRIMARY outcome

Timeframe: 2 Month

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

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).

Outcome measures

Measure	Online and Text Message Intervention n=71 Participants 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.	Assessment Only Control n=71 Participants 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.
Cannabis Protective Behavioral Strategies	3.56 Units on a 1-6 scale Standard Deviation 1.03	3.61 Units on a 1-6 scale Standard Deviation 1.23

PRIMARY outcome

Timeframe: Baseline

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

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

Outcome measures

Measure	Online and Text Message Intervention n=76 Participants 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.	Assessment Only Control n=74 Participants 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.
Marijuana Consequences Questionnaire	28.16 Number of cannabis consequences Standard Deviation 16.41	28.83 Number of cannabis consequences Standard Deviation 20.73

PRIMARY outcome

Timeframe: 2 Month

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

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

Outcome measures

Measure	Online and Text Message Intervention n=73 Participants 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.	Assessment Only Control n=71 Participants 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.
Marijuana Consequences Questionnaire	20.76 Number of cannabis consequences Standard Deviation 20.34	21.38 Number of cannabis consequences Standard Deviation 18.20

PRIMARY outcome

Timeframe: Baseline

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

Questions regarding SAM use will be adapted from MTF.

Outcome measures

Measure	Online and Text Message Intervention n=75 Participants 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.	Assessment Only Control n=75 Participants 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.
Simultaneous Alcohol and Marijuana Use	.93 Number of times SAM use past two months Standard Deviation .251	.93 Number of times SAM use past two months Standard Deviation .250

PRIMARY outcome

Timeframe: 2 Month

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

Questions regarding SAM use will be adapted from MTF.

Outcome measures

Measure	Online and Text Message Intervention n=74 Participants 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.	Assessment Only Control n=71 Participants 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.
Simultaneous Alcohol and Marijuana Use	.88 Number of times SAM use past two months Standard Deviation .332	.83 Number of times SAM use past two months Standard Deviation .377

PRIMARY outcome

Timeframe: 2 Month

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

The Number of Participants who Visited the Online Intervention

Outcome measures

Measure	Online and Text Message Intervention n=78 Participants 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.	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.
Feasibility- Number of Participants Who Visited the Online Intervention	78 Participants	—

PRIMARY outcome

Timeframe: Baseline

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

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

Outcome measures

Measure	Online and Text Message Intervention n=78 Participants 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.	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.
Feasibility- Number of Online Modules Selected	8.80 Mean modules selected Standard Deviation 2.80	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Online and Text Message Intervention n=78 Participants 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.	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.
Acceptability- System Usability Scale	76.60 Mean SUS score Standard Deviation 13.20	—

Adverse Events

Online and Text Message Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Assessment Only Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Melissa Lewis

University of Texas at Arlington

Phone: 817-272-9833

Email: Melissa.Lewis@uta.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place