Substance-related DisordersNCT07655609
LaunchPad: Supporting Healthy Decisions and Preventing Drug Use After High School
A study testing Introduction, Norms re: Protective Behavior Strategies (PBS) and Life Skills in people with Substance-related Disorders and Alcohol-Related Disorders, run by Prevention Strategies, LLC.
Trial summary
LaunchPad is an online substance use prevention program for high school seniors. The program is designed to help seniors develop skills and make informed decisions as they transition from high school to young adulthood. Read more about this study
- Who is it for?
- Ages 15 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance-related Disorders, Alcohol-Related Disorders, Tobacco Use Disorder
- What is being tested?
- Introduction, Norms re: Protective Behavior Strategies (PBS) and Life Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Schools:
- Public or private school in the U.S. enrolling 12th grade students
- Agree to (1) provide us contact information for students and parents (or to send study information to students and parents themselves), (2) identify a school contact person (typically a school counselor) who will work with us to carry out the study (recruitment, pretest survey, intervention deployment, posttest survey), and (3) either provide school time to complete the intervention or integrate the intervention into a class (e.g., as an out-of-class assignment)
Students:
- Enrolled as a 12th grade student at one of the participating schools
- Have not completed a previous version of the intervention before
- Between the ages of 15 and 21 years of age
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preventing Drug Use Onset and Progression Toward Addiction During a Critical Transition Period: Optimizing an Online Intervention for High School Seniors
LaunchPad is an online substance use prevention program for high school seniors. The program is designed to help seniors develop skills and make informed decisions as they transition from high school to young adulthood.
The purpose of this clinical trial is to learn whether individual LaunchPad lessons improve the specific attitudes, intentions, and skills they are designed to address. For example, researchers will examine whether the stress management lesson increases students' intentions to use healthy ways of managing stress.
Read more
The main question this study aims to answer is: Does each individual LaunchPad lesson improve the specific outcomes it was designed to address?
Researchers will compare students who receive a particular lesson with students who do not receive that lesson to determine whether the lesson changes the intended outcome.
Participants will:
- Complete a brief baseline survey
- Complete two introductory online lessons
- Complete one or more randomly assigned LaunchPad lessons
- Complete a brief follow-up survey
All surveys and lessons will be completed online.
Read the detailed description
LaunchPad is an online substance use prevention program designed for high school seniors as they prepare for the transition to young adulthood. The program is being developed and optimized using the Multiphase Optimization Strategy (MOST), an engineering-inspired framework for building effective and efficient behavioral interventions. Rather than evaluating the program as a single intervention "package", researchers evaluate individual lessons and determine which lessons contribute meaningfully to desired outcomes before assembling an effective and efficient (i.e., "optimized") intervention package.
The current study, Trial I, is the first of two planned trials in the Optimization Phase of MOST. Trial I is designed to evaluate whether five theory-informed LaunchPad lessons produce their intended short-term effects on risk and protective factors associated with substance use during the transition out of high school. All participating students will receive two introductory lessons. Students will then receive different combinations of five additional lessons that target factors such as perceptions of substance use among young adults, stress management skills, making friends without using alcohol or other drugs, and other skills and beliefs associated lower risk of substance use among young adults.
The study will recruit approximately 48 high schools across the United States. To make it easier for schools and because students within a school may discuss intervention content, schools will be assigned to study conditions rather than individual students. Participating schools will be randomly assigned to one of 16 experimental conditions using a cluster-randomized fractional factorial design. This design allows researchers to efficiently estimate the effect of each lesson on its targeted outcomes.
Parents or guardians of seniors at each participating high school will be notified about the study and provided an opportunity to opt their child out of participation. Students whose parents do not opt them out and who provide assent (<18 years old) or consent (18 or older), will be eligible to participate. When required by participating schools, active (opt in) consent procedures will be used for parents or guardians. Schools will be able to implement the program between September 1 and April 2, depending on when it works for them. Participating schools will complete: a brief baseline survey, the LaunchPad lessons assigned to their school, and an immediate post-intervention survey.
Students will access LaunchPad through a learning management system using a computer, tablet, or smartphone. Survey responses will be linked across assessment periods using unique study identifiers generated within the course management system.
The primary purpose of Trial I is to determine whether each lesson changes the factors it was designed to influence. Primary outcomes include changes in the targeted attitudes, beliefs, perceptions, and skills assessed immediately following intervention completion. Information from participant surveys, behavioral engagement data, and participant feedback will also be used to assess the acceptability and usability of the lessons and to identify opportunities for improvement.
Findings from Trial I will be used to identify which lessons do not yet achieve the desired effects on their targeted outcomes. Findings will be combined with feedback from participating students, young adults, school staff, and expert consultants to inform revisions to lesson content and delivery. The revised lessons will be tested in a subsequent optimization trial.
- Conditions
- Substance-related Disorders, Alcohol-Related Disorders, Tobacco Use Disorder, Marijuana Use
- Being tested
- Introduction, Norms re: Protective Behavior Strategies (PBS), Life Skills, Norms re: Bystander Intervention Strategies, Making Friends
- Keywords
- Adolescence, Adolescent and Young Adult, Alcohol, Behavior, Decision Making, Development, Expectancy, High School Student, Intervention, Marijuana, Schools, Substance Use Prevention, Transition out of high school, Multi-phase Optimization Strategy, Normative Education
- Medical subject headings
- Substance-Related Disorders, Alcohol-Related Disorders, Tobacco Use Disorder, Marijuana Use, Behavior, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntroductionBehavioural
Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans.
Norms re: Protective Behavior Strategies (PBS)Behavioural
Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using protective strategies to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use.
Life SkillsBehavioural
Teaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety.
Norms re: Bystander Intervention StrategiesBehavioural
Provides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers.
Making FriendsBehavioural
Teaches strategies to make friends without SU.
Norms about Substance UseBehavioural
Corrects misperceptions about prevalence of SU among young adults and young adults' approval of SU.
| Study group | Role | What they receive |
|---|---|---|
| Introduction + Norms re: Bystander Intervention | Experimental | (1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Provides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers. Receives: Behavioral: Introduction; Behavioral: Norms re: Bystander Intervention Strategies |
| Introduction + Norms re: Protective Behavior Strategies (PBS) | Experimental | (1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using protective strategies to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use. Receives: Behavioral: Introduction; Behavioral: Norms re: Protective Behavior Strategies (PBS) |
| Introduction + Life Skills | Experimental | (1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Teaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety. Receives: Behavioral: Introduction; Behavioral: Life Skills |
| Introduction + Life Skills + Norms re: PBS + Norms re: Bystander Intervention | Experimental | (1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Teaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety. (3) Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using protective strategies to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use. (4) Provides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers. Receives: Behavioral: Introduction; Behavioral: Norms re: Protective Behavior Strategies (PBS); Behavioral: Life Skills; Behavioral: Norms re: Bystander Intervention Strategies |
| Introduction + Making Friends | Experimental | (1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Teaches strategies to make friends without SU. Receives: Behavioral: Introduction; Behavioral: Making Friends |
| Introduction + Making Friends + Norms re: PBS + Norms re: Bystander Intervention | Experimental | (1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans.(2) Teaches strategies to make friends without SU. (3) Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using protective strategies to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use. (4) Provides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers. Receives: Behavioral: Introduction; Behavioral: Norms re: Protective Behavior Strategies (PBS); Behavioral: Norms re: Bystander Intervention Strategies; Behavioral: Making Friends |
| Introduction + Making Friends + Life Skills + Norms re: Bystander Intervention | Experimental | (1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Teaches strategies to make friends without SU. (3) Teaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety. (4) Provides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers. Receives: Behavioral: Introduction; Behavioral: Life Skills; Behavioral: Norms re: Bystander Intervention Strategies; Behavioral: Making Friends |
| Introduction + Making Friends + Life Skills + Norms re: Protective Behavior Strategies | Experimental | (1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Teaches strategies to make friends without SU. (3) Teaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety. (4) Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using protective strategies to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use. Receives: Behavioral: Introduction; Behavioral: Norms re: Protective Behavior Strategies (PBS); Behavioral: Life Skills; Behavioral: Making Friends |
| Introduction + Norms about Substance Use | Experimental | (1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Corrects misperceptions about prevalence of SU among young adults and young adults' approval of SU. Receives: Behavioral: Introduction; Behavioral: Norms about Substance Use |
| Introduction + Norms about Substance Use + Norms re: PBS + Norms re: Bystander Intervention | Experimental | (1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Corrects misperceptions about prevalence of SU among young adults and young adults' approval of SU. (3) Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using protective strategies to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use. (4) Provides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers. Receives: Behavioral: Introduction; Behavioral: Norms re: Protective Behavior Strategies (PBS); Behavioral: Norms re: Bystander Intervention Strategies; Behavioral: Norms about Substance Use |
| Introduction + Norms about Substance Use + Life Skills + Norms re: Bystander Intervention | Experimental | (1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Corrects misperceptions about prevalence of SU among young adults and young adults' approval of SU. (3) Teaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety. (4) Provides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers. Receives: Behavioral: Introduction; Behavioral: Life Skills; Behavioral: Norms re: Bystander Intervention Strategies; Behavioral: Norms about Substance Use |
| Introduction + Norms about Substance Use + Life Skills + Norms re: Protective Behavior Strategies | Experimental | (1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Corrects misperceptions about prevalence of SU among young adults and young adults' approval of SU. (3) Teaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety. (4) Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using protective strategies to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use. Receives: Behavioral: Introduction; Behavioral: Norms re: Protective Behavior Strategies (PBS); Behavioral: Life Skills; Behavioral: Norms about Substance Use |
| Introduction + Norms about Substance Use + Making Friends + Norms re: Bystander Intervention | Experimental | (1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Corrects misperceptions about prevalence of SU among young adults and young adults' approval of SU. (3) Teaches strategies to make friends without SU. (4) Provides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers. Receives: Behavioral: Introduction; Behavioral: Norms re: Bystander Intervention Strategies; Behavioral: Making Friends; Behavioral: Norms about Substance Use |
| Introduction + Norms about Substance Use + Making Friends + Norms re: PBS | Experimental | (1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Corrects misperceptions about prevalence of SU among young adults and young adults' approval of SU. (3) Teaches strategies to make friends without SU. (4) Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using protective strategies to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use. Receives: Behavioral: Introduction; Behavioral: Norms re: Protective Behavior Strategies (PBS); Behavioral: Making Friends; Behavioral: Norms about Substance Use |
| Introduction + Norms about Substance Use + Making Friends + Life Skills | Experimental | (1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Corrects misperceptions about prevalence of SU among young adults and young adults' approval of SU. (3) Teaches strategies to make friends without SU. (4) Teaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety. Receives: Behavioral: Introduction; Behavioral: Life Skills; Behavioral: Making Friends; Behavioral: Norms about Substance Use |
| Intro + Norms re SU + Making Friends + Life Skills + Norms re PBS + Norms re: Bystander Intervention | Experimental | (1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Corrects misperceptions about prevalence of SU among young adults and young adults' approval of SU. (3) Teaches strategies to make friends without SU. (4) Teaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety. (5) Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using PBS to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use. (6) Provides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers. Receives: Behavioral: Introduction; Behavioral: Norms re: Protective Behavior Strategies (PBS); Behavioral: Life Skills; Behavioral: Norms re: Bystander Intervention Strategies; Behavioral: Making Friends; Behavioral: Norms about Substance Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance Use Injunctive Norms
To capture students' perceived approval of substance use among their peers, they will indicate how much typical same-sex college students and typical same-sex young adults not in college approve of: Drinking daily; Having 4-5 drinks nearly every day; Having 5 or more drinks once or twice each weekend; Trying marijuana once or twice; Using marijuana occasionally; Using marijuana regularly; Smoking one or packs of cigarettes a day; Using e-cigarettes/vaping. Response options will be 1=strongly disapprove to 7=strongly approve. Responses will be averaged across reference groups but each substance will be analyzed separately.
Measured: This measure will be completed at the pretest and immediate posttest
Substance Use Descriptive Norms
To capture students' perceived frequency of substance use among their peers, students will indicate what percentage of typical same-sex college students and typical same sex young adults not in college have done the following in the past 30 days: Drank alcohol, been drunk, used marijuana, smoked cigarettes, used e-cigarettes / vaped. Students will also indicate what percentage of each group they think have had 5 or more drinks in the past 2 weeks. The questions will allow open ended responses ranging from 0-100. Responses will be averaged across reference groups but each substance will be analyzed separately.
Measured: This measure will be completed at the pretest and immediate posttest.
Social self-efficacy
Students will report how confident they are that they could do things to meet new people in real situations. For example ("Start a conversation with someone you don't know or just met"; "Get to know new people without using alcohol or other drugs"). Response options will be 1 = Not at all confident to 4 = Completely confident. Responses will be averaged across items.
Measured: This measure will be completed at the pretest and immediate posttest.
Beliefs about social belonging without substance use
Students will indicate how much they agree with statements about the importance of substance use for young adults to make friends. Response options will range from 1 = strongly disagree to 6 = strongly agree. Responses will be averaged across items.
Measured: This measure will be completed at the pretest and immediate posttest.
Substance use refusal self efficacy
Students will indicate how confident they are that they could resist drinking or using drugs in different situations. There are three subscales: For emotional relief (e.g., When I feel upset), opportunistic situations (e.g., when I am at a party), and in situations where there is social facilitation (e.g., when I want to feel more accepted by my friends). Response options will range from 1 = I am very sure I could NOT resist drinking or using drugs to 6 = I am very sure I could resist drinking or using drugs. Responses will be averaged across items to create a single measure.
Measured: This measure will be completed at the pretest and immediate posttest.
Injunctive norms about Protective Behavioral Strategies
Students will report "how you think young adults feel if their friends did the following." Item content will be adapted from measures of alcohol, marijuana, and smoking / vaping harm prevention / protective behavioral strategies (e.g., "Refused to ride with a driver who had been drinking alcohol"; "Refused to play a drinking game even when everyone else is playing"). Response options will be 1=strongly disapprove to 6=strongly approve. Responses will be averaged across items.
Measured: This measure will be completed at the pretest and immediate posttest.
Injunctive norms about consequences of substance use
Students will report "how you think young adults feel if their friends did the following." Item content will be adapted from measures of alcohol, marijuana, and smoking / vaping consequences (e.g., "Said or did embarrassing things while drinking or using marijuana"; "Got into an argument or fight with someone after they had been drinking or using marijuana"). Response options will be 1=strongly disapprove to 6=strongly approve. Responses will be averaged across items.
Measured: This measure will be completed at the pretest and immediate posttest.
Attitudes about using Protective Behavioral Strategies
Students will identify how they feel about using protective behavioral strategies. Response options will be on a 5 point scale with anchors such as 1 = harmful vs 5 = beneficial and 1 = not worth it and 5 = worth it. Responses will be averaged across items.
Measured: This measure will be completed at the pretest and immediate posttest.
Intentions to use stress management skills
Students will complete a measure adapted from several subscales from the Brief COPE to indicate how often they intend to use different strategies to cope with stress over the next 3 months. The substance use items are: "Use alcohol to feel better", "Use marijuana (weed) to relax or feel better" and "Use nicotine pouches to relax". Response options will range from 1 = Never to 4 = Often. Responses will be averaged across items within the same subscale.
Measured: This measure will be completed at the pretest and immediate posttest.
Self efficacy to use different stress management skills
Students will complete a measure adapted from several subscales from the Brief COPE to indicate how confident they are that they could use different adaptive coping strategies. For example, "Break a big problem into smaller, manageable steps" and "Refrain from using alcohol, marijuana, nicotine (smoking, vapes, pouches) or other substances." Response options will range from 1 = Not at all confident" to 4 = Completely confident. Responses will be averaged across items.
Measured: This measure will be completed at the pretest and immediate posttest.
Injunctive norms about Bystander Intervention
To capture students' norms around the social acceptability of bystander intervention, they will indicate how they think most young adults would feel about their friends intervening in different ways, such as "Suggested their friends create a plan to stay safe before drinking or using drugs" and "Call for emergency help if someone is passed out, even if that person could get in trouble". Response options will range from 1 = Strongly disapprove to 6 = Strongly approve. Responses will be averaged across items.
Measured: This measure will be completed at the pretest and immediate posttest.
Attitudes about Bystander Intervention
Students will indicate how much they agree with several statements about bystander intervention: "It's my responsibility to look out for my friends when alcohol or drugs are involved" and "It's important for me to say or do something if a friend's drinking or drug use seems risky, even if it feels awkward". Response options will range from 1 = Strongly disagree to 6 = Strongly agree. Responses will be averaged across items.
Measured: This measure will be completed at the pretest and immediate posttest.
Self efficacy to intervene
Students will rate how confident they are that they could engage in different bystander behaviors, such as "Ask a peer who seems very drunk or high if they are okay, even if you don't know them well" and "Tell a friend you are worried about how much they had been drinking or using drugs."
Measured: This measure will be completed at the pretest and immediate posttest.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-related DisordersStudies 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
- Factorial
- Model description
- This study uses a 2\^(5-1) fractional factorial design. LaunchPad has 7 lessons. All students will receive the two introductory lessons, as they provide foundational information. Researchers will experimentally manipulate the other 5 components, which requires 16 intervention conditions. Each condition will consist of the introduction lessons plus one or more other lessons. To avoid contagion across conditions, the study uses a cluster-randomized design, with schools as clusters. Each school will be assigned to one of the 16 intervention conditions.
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prevention Strategies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), NORC at the University of Chicago
- Responsible party
- Sponsor
- Investigators
- Kelly Rulison, PhD, Principal investigator, Prevention Strategies, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655609
- Sponsor's protocol ID
- LaunchPad
- Other IDs
- 5R01DA058697-02
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected as part of the trial
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Drug Use Onset and Progression Toward Addiction During a Critical Transition Period: Optimizing an Online Intervention for High School Seniors
- ClinicalTrials.gov ID
- NCT07655609
- Acronym / sponsor ID
- LaunchPad
- Conditions
- Substance-related Disorders, Alcohol-Related Disorders, Tobacco Use Disorder, Marijuana Use
- Keywords
- Adolescence, Adolescent and Young Adult, Alcohol, Behavior, Decision Making, Development, Expectancy, High School Student
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Prevention Strategies, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), NORC at the University of Chicago
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LaunchPad is an online substance use prevention program for high school seniors. The program is designed to help seniors develop skills and make informed decisions as they transition from high school to young adulthood.
The purpose of this clinical trial is to learn whether individual LaunchPad lessons improve the specific attitudes, intentions, and skills they are designed to address. For example, researchers will examine whether the stress management lesson increases students' intentions to use healthy ways of managing stress.
The main question this study aims to answer is: Does each individual LaunchPad lesson improve the specific outcomes it was designed to address?
Researchers will compare students who receive a particular lesson with students who do not receive that lesson to determine whether the lesson changes the intended outcome.
Participants will:
- Complete a brief baseline survey
- Complete two introductory online lessons
- Complete one or more randomly assigned LaunchPad lessons
- Complete a brief follow-up survey
All surveys and lessons will be completed online.
Detailed description
LaunchPad is an online substance use prevention program designed for high school seniors as they prepare for the transition to young adulthood. The program is being developed and optimized using the Multiphase Optimization Strategy (MOST), an engineering-inspired framework for building effective and efficient behavioral interventions. Rather than evaluating the program as a single intervention "package", researchers evaluate individual lessons and determine which lessons contribute meaningfully to desired outcomes before assembling an effective and efficient (i.e., "optimized") intervention package.
The current study, Trial I, is the first of two planned trials in the Optimization Phase of MOST. Trial I is designed to evaluate whether five theory-informed LaunchPad lessons produce their intended short-term effects on risk and protective factors associated with substance use during the transition out of high school. All participating students will receive two introductory lessons. Students will then receive different combinations of five additional lessons that target factors such as perceptions of substance use among young adults, stress management skills, making friends without using alcohol or other drugs, and other skills and beliefs associated lower risk of substance use among young adults.
The study will recruit approximately 48 high schools across the United States. To make it easier for schools and because students within a school may discuss intervention content, schools will be assigned to study conditions rather than individual students. Participating schools will be randomly assigned to one of 16 experimental conditions using a cluster-randomized fractional factorial design. This design allows researchers to efficiently estimate the effect of each lesson on its targeted outcomes.
Parents or guardians of seniors at each participating high school will be notified about the study and provided an opportunity to opt their child out of participation. Students whose parents do not opt them out and who provide assent (<18 years old) or consent (18 or older), will be eligible to participate. When required by participating schools, active (opt in) consent procedures will be used for parents or guardians. Schools will be able to implement the program between September 1 and April 2, depending on when it works for them. Participating schools will complete: a brief baseline survey, the LaunchPad lessons assigned to their school, and an immediate post-intervention survey.
Students will access LaunchPad through a learning management system using a computer, tablet, or smartphone. Survey responses will be linked across assessment periods using unique study identifiers generated within the course management system.
The primary purpose of Trial I is to determine whether each lesson changes the factors it was designed to influence. Primary outcomes include changes in the targeted attitudes, beliefs, perceptions, and skills assessed immediately following intervention completion. Information from participant surveys, behavioral engagement data, and participant feedback will also be used to assess the acceptability and usability of the lessons and to identify opportunities for improvement.
Findings from Trial I will be used to identify which lessons do not yet achieve the desired effects on their targeted outcomes. Findings will be combined with feedback from participating students, young adults, school staff, and expert consultants to inform revisions to lesson content and delivery. The revised lessons will be tested in a subsequent optimization trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 16
- Model description
- This study uses a 2^(5-1) fractional factorial design. LaunchPad has 7 lessons. All students will receive the two introductory lessons, as they provide foundational information. Researchers will experimentally manipulate the other 5 components, which requires 16 intervention conditions. Each condition will consist of the introduction lessons plus one or more other lessons. To avoid contagion across conditions, the study uses a cluster-randomized design, with schools as clusters. Each school will be assigned to one of the 16 intervention conditions.
| Arm | Type | Receives |
|---|---|---|
| Introduction + Norms re: Bystander Intervention | Experimental | Behavioral: Introduction, Behavioral: Norms re: Bystander Intervention Strategies(1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Provides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers. |
| Introduction + Norms re: Protective Behavior Strategies (PBS) | Experimental | Behavioral: Introduction, Behavioral: Norms re: Protective Behavior Strategies (PBS)(1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using protective strategies to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use. |
| Introduction + Life Skills | Experimental | Behavioral: Introduction, Behavioral: Life Skills(1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Teaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety. |
| Introduction + Life Skills + Norms re: PBS + Norms re: Bystander Intervention | Experimental | Behavioral: Introduction, Behavioral: Norms re: Protective Behavior Strategies (PBS), Behavioral: Life Skills, Behavioral: Norms re: Bystander Intervention Strategies(1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Teaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety. (3) Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using protective strategies to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use. (4) Provides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers. |
| Introduction + Making Friends | Experimental | Behavioral: Introduction, Behavioral: Making Friends(1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Teaches strategies to make friends without SU. |
| Introduction + Making Friends + Norms re: PBS + Norms re: Bystander Intervention | Experimental | Behavioral: Introduction, Behavioral: Norms re: Protective Behavior Strategies (PBS), Behavioral: Norms re: Bystander Intervention Strategies, Behavioral: Making Friends(1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans.(2) Teaches strategies to make friends without SU. (3) Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using protective strategies to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use. (4) Provides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers. |
| Introduction + Making Friends + Life Skills + Norms re: Bystander Intervention | Experimental | Behavioral: Introduction, Behavioral: Life Skills, Behavioral: Norms re: Bystander Intervention Strategies, Behavioral: Making Friends(1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Teaches strategies to make friends without SU. (3) Teaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety. (4) Provides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers. |
| Introduction + Making Friends + Life Skills + Norms re: Protective Behavior Strategies | Experimental | Behavioral: Introduction, Behavioral: Norms re: Protective Behavior Strategies (PBS), Behavioral: Life Skills, Behavioral: Making Friends(1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Teaches strategies to make friends without SU. (3) Teaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety. (4) Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using protective strategies to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use. |
| Introduction + Norms about Substance Use | Experimental | Behavioral: Introduction, Behavioral: Norms about Substance Use(1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Corrects misperceptions about prevalence of SU among young adults and young adults' approval of SU. |
| Introduction + Norms about Substance Use + Norms re: PBS + Norms re: Bystander Intervention | Experimental | Behavioral: Introduction, Behavioral: Norms re: Protective Behavior Strategies (PBS), Behavioral: Norms re: Bystander Intervention Strategies, Behavioral: Norms about Substance Use(1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Corrects misperceptions about prevalence of SU among young adults and young adults' approval of SU. (3) Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using protective strategies to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use. (4) Provides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers. |
| Introduction + Norms about Substance Use + Life Skills + Norms re: Bystander Intervention | Experimental | Behavioral: Introduction, Behavioral: Life Skills, Behavioral: Norms re: Bystander Intervention Strategies, Behavioral: Norms about Substance Use(1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Corrects misperceptions about prevalence of SU among young adults and young adults' approval of SU. (3) Teaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety. (4) Provides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers. |
| Introduction + Norms about Substance Use + Life Skills + Norms re: Protective Behavior Strategies | Experimental | Behavioral: Introduction, Behavioral: Norms re: Protective Behavior Strategies (PBS), Behavioral: Life Skills, Behavioral: Norms about Substance Use(1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Corrects misperceptions about prevalence of SU among young adults and young adults' approval of SU. (3) Teaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety. (4) Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using protective strategies to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use. |
| Introduction + Norms about Substance Use + Making Friends + Norms re: Bystander Intervention | Experimental | Behavioral: Introduction, Behavioral: Norms re: Bystander Intervention Strategies, Behavioral: Making Friends, Behavioral: Norms about Substance Use(1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Corrects misperceptions about prevalence of SU among young adults and young adults' approval of SU. (3) Teaches strategies to make friends without SU. (4) Provides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers. |
| Introduction + Norms about Substance Use + Making Friends + Norms re: PBS | Experimental | Behavioral: Introduction, Behavioral: Norms re: Protective Behavior Strategies (PBS), Behavioral: Making Friends, Behavioral: Norms about Substance Use(1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Corrects misperceptions about prevalence of SU among young adults and young adults' approval of SU. (3) Teaches strategies to make friends without SU. (4) Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using protective strategies to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use. |
| Introduction + Norms about Substance Use + Making Friends + Life Skills | Experimental | Behavioral: Introduction, Behavioral: Life Skills, Behavioral: Making Friends, Behavioral: Norms about Substance Use(1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Corrects misperceptions about prevalence of SU among young adults and young adults' approval of SU. (3) Teaches strategies to make friends without SU. (4) Teaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety. |
| Intro + Norms re SU + Making Friends + Life Skills + Norms re PBS + Norms re: Bystander Intervention | Experimental | Behavioral: Introduction, Behavioral: Norms re: Protective Behavior Strategies (PBS), Behavioral: Life Skills, Behavioral: Norms re: Bystander Intervention Strategies, Behavioral: Making Friends, Behavioral: Norms about Substance Use(1) Discusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. (2) Corrects misperceptions about prevalence of SU among young adults and young adults' approval of SU. (3) Teaches strategies to make friends without SU. (4) Teaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety. (5) Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using PBS to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use. (6) Provides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers. |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| IntroductionDiscusses choices and challenges students face as they transition out of high school to promote participant buy-in. Explains the consequences of SU, focusing on how these consequences can interfere with their life plans. | Behavioural | Intro + Norms re SU + Making Friends + Life Skills + Norms re PBS + Norms re: Bystander Intervention, Introduction + Life Skills, Introduction + Life Skills + Norms re: PBS + Norms re: Bystander Intervention, Introduction + Making Friends, Introduction + Making Friends + Life Skills + Norms re: Bystander Intervention, Introduction + Making Friends + Life Skills + Norms re: Protective Behavior Strategies, Introduction + Making Friends + Norms re: PBS + Norms re: Bystander Intervention, Introduction + Norms about Substance Use, Introduction + Norms about Substance Use + Life Skills + Norms re: Bystander Intervention, Introduction + Norms about Substance Use + Life Skills + Norms re: Protective Behavior Strategies, Introduction + Norms about Substance Use + Making Friends + Life Skills, Introduction + Norms about Substance Use + Making Friends + Norms re: Bystander Intervention, Introduction + Norms about Substance Use + Making Friends + Norms re: PBS, Introduction + Norms about Substance Use + Norms re: PBS + Norms re: Bystander Intervention, Introduction + Norms re: Bystander Intervention, Introduction + Norms re: Protective Behavior Strategies (PBS) |
| Norms re: Protective Behavior Strategies (PBS)Provides messages from young adults that reveal positive attitudes (i.e., high injunctive norms) about using protective strategies to limit exposure to risky situations and behaviors. Messages will also emphasize low approval toward negative consequences of SU to motivate the need for PBS use. | Behavioural | Intro + Norms re SU + Making Friends + Life Skills + Norms re PBS + Norms re: Bystander Intervention, Introduction + Life Skills + Norms re: PBS + Norms re: Bystander Intervention, Introduction + Making Friends + Life Skills + Norms re: Protective Behavior Strategies, Introduction + Making Friends + Norms re: PBS + Norms re: Bystander Intervention, Introduction + Norms about Substance Use + Life Skills + Norms re: Protective Behavior Strategies, Introduction + Norms about Substance Use + Making Friends + Norms re: PBS, Introduction + Norms about Substance Use + Norms re: PBS + Norms re: Bystander Intervention, Introduction + Norms re: Protective Behavior Strategies (PBS) |
| Life SkillsTeaches social and decision-making skills such as SU refusal skills and strategies for coping with stress and anxiety. | Behavioural | Intro + Norms re SU + Making Friends + Life Skills + Norms re PBS + Norms re: Bystander Intervention, Introduction + Life Skills, Introduction + Life Skills + Norms re: PBS + Norms re: Bystander Intervention, Introduction + Making Friends + Life Skills + Norms re: Bystander Intervention, Introduction + Making Friends + Life Skills + Norms re: Protective Behavior Strategies, Introduction + Norms about Substance Use + Life Skills + Norms re: Bystander Intervention, Introduction + Norms about Substance Use + Life Skills + Norms re: Protective Behavior Strategies, Introduction + Norms about Substance Use + Making Friends + Life Skills |
| Norms re: Bystander Intervention StrategiesProvides normative feedback about intervening on behalf of peers and teaches strategies to intervene on behalf of peers. | Behavioural | Intro + Norms re SU + Making Friends + Life Skills + Norms re PBS + Norms re: Bystander Intervention, Introduction + Life Skills + Norms re: PBS + Norms re: Bystander Intervention, Introduction + Making Friends + Life Skills + Norms re: Bystander Intervention, Introduction + Making Friends + Norms re: PBS + Norms re: Bystander Intervention, Introduction + Norms about Substance Use + Life Skills + Norms re: Bystander Intervention, Introduction + Norms about Substance Use + Making Friends + Norms re: Bystander Intervention, Introduction + Norms about Substance Use + Norms re: PBS + Norms re: Bystander Intervention, Introduction + Norms re: Bystander Intervention |
| Making FriendsTeaches strategies to make friends without SU. | Behavioural | Intro + Norms re SU + Making Friends + Life Skills + Norms re PBS + Norms re: Bystander Intervention, Introduction + Making Friends, Introduction + Making Friends + Life Skills + Norms re: Bystander Intervention, Introduction + Making Friends + Life Skills + Norms re: Protective Behavior Strategies, Introduction + Making Friends + Norms re: PBS + Norms re: Bystander Intervention, Introduction + Norms about Substance Use + Making Friends + Life Skills, Introduction + Norms about Substance Use + Making Friends + Norms re: Bystander Intervention, Introduction + Norms about Substance Use + Making Friends + Norms re: PBS |
| Norms about Substance UseCorrects misperceptions about prevalence of SU among young adults and young adults' approval of SU. | Behavioural | Intro + Norms re SU + Making Friends + Life Skills + Norms re PBS + Norms re: Bystander Intervention, Introduction + Norms about Substance Use, Introduction + Norms about Substance Use + Life Skills + Norms re: Bystander Intervention, Introduction + Norms about Substance Use + Life Skills + Norms re: Protective Behavior Strategies, Introduction + Norms about Substance Use + Making Friends + Life Skills, Introduction + Norms about Substance Use + Making Friends + Norms re: Bystander Intervention, Introduction + Norms about Substance Use + Making Friends + Norms re: PBS, Introduction + Norms about Substance Use + Norms re: PBS + Norms re: Bystander Intervention |
Primary outcome
Substance Use Injunctive Norms
Time frame: This measure will be completed at the pretest and immediate posttest
To capture students' perceived approval of substance use among their peers, they will indicate how much typical same-sex college students and typical same-sex young adults not in college approve of: Drinking daily; Having 4-5 drinks nearly every day; Having 5 or more drinks once or twice each weekend; Trying marijuana once or twice; Using marijuana occasionally; Using marijuana regularly; Smoking one or packs of cigarettes a day; Using e-cigarettes/vaping. Response options will be 1=strongly disapprove to 7=strongly approve. Responses will be averaged across reference groups but each substance will be analyzed separately.
Substance Use Descriptive Norms
Time frame: This measure will be completed at the pretest and immediate posttest.
To capture students' perceived frequency of substance use among their peers, students will indicate what percentage of typical same-sex college students and typical same sex young adults not in college have done the following in the past 30 days: Drank alcohol, been drunk, used marijuana, smoked cigarettes, used e-cigarettes / vaped. Students will also indicate what percentage of each group they think have had 5 or more drinks in the past 2 weeks. The questions will allow open ended responses ranging from 0-100. Responses will be averaged across reference groups but each substance will be analyzed separately.
Social self-efficacy
Time frame: This measure will be completed at the pretest and immediate posttest.
Students will report how confident they are that they could do things to meet new people in real situations. For example ("Start a conversation with someone you don't know or just met"; "Get to know new people without using alcohol or other drugs"). Response options will be 1 = Not at all confident to 4 = Completely confident. Responses will be averaged across items.
Beliefs about social belonging without substance use
Time frame: This measure will be completed at the pretest and immediate posttest.
Students will indicate how much they agree with statements about the importance of substance use for young adults to make friends. Response options will range from 1 = strongly disagree to 6 = strongly agree. Responses will be averaged across items.
Substance use refusal self efficacy
Time frame: This measure will be completed at the pretest and immediate posttest.
Students will indicate how confident they are that they could resist drinking or using drugs in different situations. There are three subscales: For emotional relief (e.g., When I feel upset), opportunistic situations (e.g., when I am at a party), and in situations where there is social facilitation (e.g., when I want to feel more accepted by my friends). Response options will range from 1 = I am very sure I could NOT resist drinking or using drugs to 6 = I am very sure I could resist drinking or using drugs. Responses will be averaged across items to create a single measure.
Injunctive norms about Protective Behavioral Strategies
Time frame: This measure will be completed at the pretest and immediate posttest.
Students will report "how you think young adults feel if their friends did the following." Item content will be adapted from measures of alcohol, marijuana, and smoking / vaping harm prevention / protective behavioral strategies (e.g., "Refused to ride with a driver who had been drinking alcohol"; "Refused to play a drinking game even when everyone else is playing"). Response options will be 1=strongly disapprove to 6=strongly approve. Responses will be averaged across items.
Injunctive norms about consequences of substance use
Time frame: This measure will be completed at the pretest and immediate posttest.
Students will report "how you think young adults feel if their friends did the following." Item content will be adapted from measures of alcohol, marijuana, and smoking / vaping consequences (e.g., "Said or did embarrassing things while drinking or using marijuana"; "Got into an argument or fight with someone after they had been drinking or using marijuana"). Response options will be 1=strongly disapprove to 6=strongly approve. Responses will be averaged across items.
Attitudes about using Protective Behavioral Strategies
Time frame: This measure will be completed at the pretest and immediate posttest.
Students will identify how they feel about using protective behavioral strategies. Response options will be on a 5 point scale with anchors such as 1 = harmful vs 5 = beneficial and 1 = not worth it and 5 = worth it. Responses will be averaged across items.
Intentions to use stress management skills
Time frame: This measure will be completed at the pretest and immediate posttest.
Students will complete a measure adapted from several subscales from the Brief COPE to indicate how often they intend to use different strategies to cope with stress over the next 3 months. The substance use items are: "Use alcohol to feel better", "Use marijuana (weed) to relax or feel better" and "Use nicotine pouches to relax". Response options will range from 1 = Never to 4 = Often. Responses will be averaged across items within the same subscale.
Self efficacy to use different stress management skills
Time frame: This measure will be completed at the pretest and immediate posttest.
Students will complete a measure adapted from several subscales from the Brief COPE to indicate how confident they are that they could use different adaptive coping strategies. For example, "Break a big problem into smaller, manageable steps" and "Refrain from using alcohol, marijuana, nicotine (smoking, vapes, pouches) or other substances." Response options will range from 1 = Not at all confident" to 4 = Completely confident. Responses will be averaged across items.
Injunctive norms about Bystander Intervention
Time frame: This measure will be completed at the pretest and immediate posttest.
To capture students' norms around the social acceptability of bystander intervention, they will indicate how they think most young adults would feel about their friends intervening in different ways, such as "Suggested their friends create a plan to stay safe before drinking or using drugs" and "Call for emergency help if someone is passed out, even if that person could get in trouble". Response options will range from 1 = Strongly disapprove to 6 = Strongly approve. Responses will be averaged across items.
Attitudes about Bystander Intervention
Time frame: This measure will be completed at the pretest and immediate posttest.
Students will indicate how much they agree with several statements about bystander intervention: "It's my responsibility to look out for my friends when alcohol or drugs are involved" and "It's important for me to say or do something if a friend's drinking or drug use seems risky, even if it feels awkward". Response options will range from 1 = Strongly disagree to 6 = Strongly agree. Responses will be averaged across items.
Self efficacy to intervene
Time frame: This measure will be completed at the pretest and immediate posttest.
Students will rate how confident they are that they could engage in different bystander behaviors, such as "Ask a peer who seems very drunk or high if they are okay, even if you don't know them well" and "Tell a friend you are worried about how much they had been drinking or using drugs."
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Yes. All IPD collected as part of the trial
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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.
Kelly Rulison, PhD principal investigator
Prevention Strategies, LLC
Questions about this trial
What is this clinical trial studying?
A study testing Introduction, Norms re: Protective Behavior Strategies (PBS) and Life Skills in people with Substance-related Disorders and Alcohol-Related Disorders, run by Prevention Strategies, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheryl Wyrick, PhD (336-324-1397, cheryl@preventionstrategies.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance Use Injunctive Norms (time frame: This measure will be completed at the pretest and immediate posttest). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2026.