Mindfulness Mobile App to Reduce Adolescent Substance Use
Phase: NA
Conditions: Adolescent Drinking, Adolescent Problem Behavior
Sponsor: Oregon Research Behavioral Intervention Strategies, Inc.

 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOL AND STATISTICAL PLAN 
 
Mindfulness Mobile App to Reduce Adolescent Substance Use 
(The Qlarity Study) 
 
Grant Number/Protocol ID:  DA043288-02 
Clinical Trials.gov ID: NCT04027075 
Federal Award Date: 5/17/2019 
 
 
 
 

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This Phase II SBIR will be conducted in two stages: 1) Product development and usability testing, and 2) 
product evaluation testing. Stage 1 and Stage 2 are outlined below and are expected to take approximately 12 
months each. 
 
Stage 1: Product development 
The Qlarity app is proposed to include 12 modules focused on mindfulness techniques for substance use 
cessation, each of which will involve 2 components: a teaching component and a practice component. During 
Phase I, we developed the initial 4 modules of the Qlarity app in order to examine the feasibility and usability 
of the app, as well as the likeability and satisfaction among our target audience. The initial 4 modules 
developed during Phase I are as follows: 1) Introduction to Mindfulness: Understanding its Application to 
Substance Use and Cessation, 2) Focusing on Current Mind and Body States: Becoming Aware of Internal 
States and their Connection to Substance Use, 3) Being In the Moment: Observing without Judging, and 4) 
Making Mindful Decisions About Substance Use. We propose to use feedback from Phase I to inform the 
development of the full 24-component a; (12 teaching + 12 practice components) that will include the following 
additional concepts aimed at reducing and eliminating substance use: 5) Understanding and Taking Charge of 
Your Emotions: Using Mindfulness Techniques to Manage Emotional States, 6) Identifying Personal and 
Contextual Triggers for Use, 7) Managing High-Stress Situations: Advanced Mindfulness Skills, 8) Mindful 
Decision-making and Refusal Skills, 9) Establishing a Support System, 10) Effectively Utilizing Existing 
Supports, 11) Planning for the Future: Maintaining Sobriety, and 12) Emergency Planning: Getting Back on 
Track When You Slip-up. 
We will use feedback from the Phase I evaluation of the initial four modules to inform and guide the 
development of the full app. Feedback on usability and attractiveness will be used to modify the initial modules 
and to provide consistency in the development of the modules. Based on this information, we will develop 
prototype versions of each module using Marvel, a design and rapid prototype development tool that yields 
functional mockups for users to interact with before any programming takes place. During an iterative process 
we will refine the mockups, present them to five test users, solicit their feedback, and continue to modify and 
refine the mockups until we arrive at an acceptable design and feature set. We will recruit adolescent test 
users who report current substance use from the community for this iterative process. 
Next, we will finalize and create all the media assets for the app, including text and graphics, images, and 
narration or other audio elements; build all program screens and user controls, and determine scoring 
algorithms and programming logic for knowledge checks and quizzes. We will incorporate a simple user 
registration component to allow for tracking of app usage while also ensuring security of user-collected data. 
 
Stage 2: Product evaluation 
We will conduct an evaluation of the Qlarity app with 380 high-risk adolescents who are involved in the 
juvenile justice system. Feasibility, usability, participant satisfaction, and intervention outcomes of substance 
use will be evaluated in an efficacy trial. Data on: 1) frequency and duration of app use, 2) number of modules 
completed, 3) changes in attitudes, emotions and behaviors, and 4) type and frequency of substance use will be 
examined. Participants will be compensated using gift cards to Amazon in the following increments: $20 for each 
of the baseline, 4 week and 3-month assessments, and $50 bonus for completion off all three assessments. 
Participants in the focus groups and usability testing will receive a $30 gift card for their time and effort. 
 
Study Design: Our evaluation of the program will be conducted with 380 adolescents ages 13- 18 who are 
referred from the Oregon Department of Youth Services (DYS) in Lane and Multnomah Counties, Oregon. 
Adolescents will be randomly and equally assigned to one of two conditions: 1) Qlarity, or 2) an active 
comparison condition that is standard treatment through the DYS (i.e., drug court, group therapy, and case 
management). All participants will be instructed to attempt to reduce substance use with a target quit date of 
1 month after program initiation (day 28). Self-reported 7-day and 30-day point prevalence abstinence for all 
substances will be measured 1 and 3 months after treatment initiation. In addition, we will collect 
biochemical verification of self-reported substance use; urinary drug tests will be conducted at the baseline, 
1- and 3-month follow ups and will follow the same UA drug testing protocol that we have found to be 
successful in our current NIH funded study with adolescents in the juvenile justice system. 
 
 

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 Participants: Participants will include both male and female high risk adolescents recruited from the 
Department of Youth Services (DYS) in Lane and Multnomah Counties, Oregon. We have a long history of 
successful collaborations with the DYS and have received their support for the current proposal. Inclusion 
criteria will be as follows: 1) ages 13-18, 2) involvement with the juvenile justice system, 3) documented 
substance use, 4) English-speaking, and 5) living in the community (e.g., biological/adoptive/foster parents). 
 
Focus Groups and Usability Testing: Twenty high-risk adolescents will be recruited to participate as 
test users in the development phase to give us initial reactions to mockup of modules, and a subgroup of 
10 of these participants will be recruited to participate in preliminary usability testing of the modules. 
Feedback from usability testing will be used to inform adaptations to the app. The prototype app will then 
be evaluated in an efficacy trial with 380 additional high-risk adolescents. The primary outcomes of the 
evaluation-testing phase will be changes in adolescent substance use attitudes and behaviors and 
emotion regulation measured at three time points: baseline, 4 weeks post- baseline (end of treatment), 
and three months post-baseline. The proposed efficacy trial will evaluate the extent that the Qlarity app 
influences positive behavior change and will provide power estimates for later larger scale evaluation.  
 
Efficacy Trial: Based on our power calculations, we will recruit 380 adolescents who are involved in 
the juvenile justice system. We have a long history of cooperation with the DYS and have well-
established recruitment procedures. Eligible adolescents and their consenting parents will be 
recruited on a continual basis and will be included in the study for 3 months post-baseline. The 
participants will be randomly and equally assigned to the Qlarity condition (n = 190) or the DC 
standard treatment condition (n = 190) following adolescent assent and parent consent. Given that 
all youth will be involved in the juvenile justice system, we will assess all services offered and 
accessed by youth in both conditions. 
Based on our prior experience, we expect many of the youth to be under orders to be participating in urine 
screening or other intervention services through DYS. Data from our current and prior studies with this 
population suggest that despite receiving random urine screens as part of their probationary status, 90% of 
youth are involved in ongoing alcohol, tobacco or other drug use (79% alcohol; 68% tobacco; 81% marijuana, 
and 53% other drug; 90% positive for one or more substance) at the time of referral. We will track additional 
services, including mandated urine screens, via official DYS reports and using a services utilization measure at 
each follow-up time point. 
 
Overview of the Proposed Intervention Conditions 
We propose to randomize youth into one of two conditions, outlined below. 
Qlarity. Subjects randomized to Qlarity will be provided in-person assistance in loading the Qlarity app 
onto their phone immediately following their baseline interview and assessment. Once the app is loaded onto 
their phone, participants will generate a username and password. The proposed modules will each include a 
teaching and a practice component that uses mindfulness techniques to reduce or avoid substance use. 
Modules will be “unlocked” in ascending order as participants move through the program (i.e., module 2 will be 
“unlocked” after completion of module 1, etc.). 
Drug Court, Group Therapy and Case Management (DC). The DC youth will receive the usual services 
provided by the DYS for youth who present with drug and alcohol use, which includes involvement in drug 
court, and case management services for the youth and their parents that span the duration of the youth’s 
probation or formal accountability contract. The drug court and case management services are provided by 
probation officers through the DYS. The DYS will manage each case and will make all decisions on referrals to 
community resources, including individual therapy, family therapy, mandated urine screens, and/or inpatient or 
outpatient substance use treatment that might occur in addition to the typical youth skill building groups and 
case management services. None of the usual services that youth in the respective study conditions receive 
will be affected by their participation in the study. We will track the youths’ and parents’ use of services as part 
of the interviews with a service utilization measure and official DYS reports of urine screens at each 
assessment. With these data, we will examine the type and length of treatment received for youth in both 
conditions, as well as the timing and outcome of urine screens over the course of the study. This services 
utilization measure has been used in previous work and has been useful for examining treatment impact. 
 
 

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Table 1. Measures 
Assessments 
Measure 
Adolescent Attitudes Questionnaire 
Alcohol and Drug Use Survey 
(MAST/DAST) 
Qlarity Usability and Satisfaction 
Cigarette Use 
Demographics 
Emotion Regulation Scale 
Five Facet Mindfulness 
Urine Drug Screens 
Youth Substance Use Interview 
(Services Utilization) 
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Data Collection Procedures 
 
Overview and timeline for the proposed data collection: In the proposed study, a total of at least 380 
youth will be recruited and baseline assessed for the study. We anticipate that approximately 10% of these will 
fail to complete the study, resulting in a sample of at least 342 youth with complete data and an intent-to-treat 
analysis strategy which will include all 380 youth. We will conduct baseline assessments and follow-up 
assessments at treatment completion (1 month), and at 3 month post-baseline.  
 
Assessments: The baseline assessment primarily measures youth risk factors, as well as past and current 
substance use, and will consist of an in-person interview including questionnaires with the youth. 
The treatment completion (1-month), and 3-month assessments are aimed at assessing short and longer 
term outcomes and will consist of two components: (a) an in-person interview and questionnaires with the youth, 
and (b) usability and satisfaction ratings for the Qlarity app. Because every participant has unique needs, we 
have standardized guidelines that allow for minor modifications to our procedures when needed. For example, 
staff will read aloud questionnaires for participants who are nonreaders, and computer-assisted questionnaires 
will be available in hardcopy format. We will travel to participant residences or other locations to conduct the 
interviews as needed. 
 
Measures: The following measures will be used to examine baseline demographic and pre- and post- 
changes in mindfulness skills, emotion regulation, and substance use: 1) Demographics, 2) Alcohol and Drug 
Use Survey, 3) Cigarette Use, 4) Adolescent Attitudes Questionnaire, 5) Emotion Regulation Scale, 6) Five 
Facet Mindfulness Questionnaire, 7) Youth Substance Use Interview (including Services Utilization), and 
8) Qlarity usability and satisfaction rating. The Alcohol and Drug Use Survey is a 48-item scale that combines 
the Michigan Alcohol Screening Test (MAST) and the Drug Abuse Screening Test (DAST) and the Self- 
Efficacy for Limiting Substance Use. These scales are widely used as measures to assess the level and 
frequency of alcohol and drug use, use of mindfulness skills, as well as the ability to limit substance use, and 
have been shown to have good psychometric 
properties. In addition, urinary drug tests will be 
conducted at the baseline, 1- and 3-month follow 
ups. UA results will be photocopied after completion, 
and the UA cups will be discarded immediately; no 
identifying information will be recorded on the UA 
cups. We will use the same UA drug testing 
procedure that we have found to be successful in our 
current NIH funded study with adolescents in the 
juvenile justice system. All data will immediately be 
moved to a secure, locked location within 
ORI/Influents Innovations accessible only to the PI 
and research staff. The Services Utilization Survey is 
an interviewer-administered instrument that collects 
information about a respondent's use of a wide range 
of services such as in- and out-patient medical care 
(hospital, clinic, or office based), mental health 
treatment, drug and alcohol abuse treatment, and 
health-related groups (e.g., Narcotics or Alcoholics Anonymous, or physical health groups). For each type of 
service accessed, there are questions regarding frequency, reason for the service (e.g., physical, mental 
health, substance-use related), insurance coverage and out-of-pocket expenses. The Five Facet Mindfulness 
Questionnaire is a 36-item self-reported questionnaire that queries aspects of mindfulness such as non- 
judgment. The Adolescent Attitudes Questionnaire is a measure of attitudes and beliefs regarding drug and 
alcohol that was adapted from an interview developed to test 12 mediators of drug use in adolescents. For this 
study, we will use the normative beliefs, lifestyle incongruence, beliefs about consequences, and commitment 
scales. The Emotion Regulation Scale is a 36-item self-report questionnaire designed to assess multiple 
aspects of emotion dysregulation. Program navigation and usability will be assessed for all participants and 
will include reports of: 1) ease of use, 2) perceived benefits of using the app, 3) likeability, and 
 
Baseline 
1 Month 
3 Month 

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4) suggestions for product development and modifications. Participants will provide ratings on 
product satisfaction and usability on a 7-point Likert Scale. Qualitative data gathered from the 
focus groups will be recorded and evaluated with the goal of identifying challenges to using the 
app, product satisfaction, and suggested product modifications. In addition to qualitative data 
gathered during the pilot evaluation study, login tracking information from the app will be used to 
assess each participant’s: 1) frequency and duration of app use and 2) number of modules 
completed. These data will be used to evaluate treatment engagement and adherence. 
 
Statistical design and power overview: This project will test the efficacy of the Qlarity app in 
Year 2 with a randomized trial that nests multiple assessments nested with 380 youth within each 
of two conditions. Half of the participants will receive the Qlarity app intervention and half will 
maintain business-as-usual. We hypothesize that Qlarity app will increase youth’s emotional 
regulation, mindfulness and self-efficacy and decrease alcohol, tobacco, and other drug use. 
Within this study design, we will test for main effects, moderation, mediation, and acceptability of 
the Qlarity app intervention and expect to detect effect sizes of 0.25 standard deviations. Program 
feasibility will be demonstrated via significant pre-post differences, a high and consistent level of 
app use, and a high degree of youth satisfaction ratings. See Human Subjects Statistical Design 
and Power section for complete details. 
 
Feasibility benchmarks: Program feasibility will be demonstrated by the achievement of the 
following benchmarks: (a) significant pre-post increases (e.g., Cohen’s d > .35) in emotional 
regulation, mindfulness, and self-efficacy, (b) significantly greater decreases in alcohol, tobacco, 
and other drug use for Qlarity participants; (c) a high consistent level of app usage (e.g., over 
70% of users used the app at least 12 times over the 12 weeks); and (d) a high degree of youth 
satisfaction and ratings of app acceptability and usability (mean ratings > 4.0 on the 5-point 
scale). Benchmarks are based on meta-analysis quantitative methods that recommend effect 
sizes of at least d >.25 to demonstrate educationally meaningful change; a desire to show at least 
an average of weekly app use by a majority of participants; and a level of participant satisfaction 
that meets or exceeds that of Phase I. 
 
 

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Data Analysis 
 
Preliminary analyses. Prior to analysis, all variables will be checked for out-of-range values and 
inter- and intra-measure consistency; frequency distributions and plots will be examined for 
unusual data distributions or data points. Any necessary data transformations will be employed. 
Initial analyses will evaluate the baseline equivalence of conditions and examine attrition effects. 
Baseline equivalence will consist of chi-square and grouped t-tests analyses comparing 
intervention condition on demographic characteristics and all baseline measures. Results of the 
baseline equivalency will be a test of the effectiveness of randomization. Any group differences 
will be treated as covariates in subsequent main-effect, moderation, and mediation analyses. 
Attrition analyses will consist of chi-square and grouped t-tests comparing proportion of 
participants in each condition who fail to complete follow-up assessments (i.e., drop-outs vs. 
completers); the independent variables will include intervention condition, demographic 
characteristics, and baseline measures. Results of main effects concerning attrition will provide 
information about the external validity of the study, and interaction effects will provide information 
about potential confounding. 
 
Main-effects analyses. Tests of the general effectiveness of the Qlarity app within this three-panel 
(pretest, 1- month, and 3-month follow-up) randomized trial requires an analysis that accounts for 
the dependence of multiple assessments nested within participants that were assigned to 
conditions. Thus, we will test most of our research hypotheses with random effects growth models 
within the hierarchical and structural equation modeling (SEM) frameworks with individual variability 
in change in study outcomes from pretest to 3-months nested within individuals. Following Singer 
and Willet when constructing the longitudinal model, we will (a) examine empirical growth plots; (b) 
fit an unconditional means model; (c) fit an unconditional linear growth model; (d) fit unconditional 
non-linear models; and (e) compare models of longitudinal change from the previous two steps 
using the Akaike Information Criterion. Individual variability change in the outcomes from baseline 
to the 3-month follow-up assessment will be modeled as a function of intervention condition. 
Intervention condition by time interactions will test whether groups differ on individual 
trajectories over the course of the study period. We will also use logistic regression models 
reporting odds ratios (OR) to test for differential rates of abstinence at the 3-month follow-up 
assessments with intervention condition a two-level predictor. 
 
Moderator effects. Moderating effects of demographics (gender and minority status) and number 
of baseline offenses will be explored by adding the moderator to the random effects growth 
models described above. The multiplicative interaction term between the participant level 
moderators constitute a three-way cross-level interaction with time in the growth models and 
addresses whether the level of the baseline moderator impacted the magnitude of intervention 
condition on change in the outcome. All significant cross-level interactions will be probed by 
computing sample-estimated intercepts and slopes of the trajectories of the outcomes at 
conditional levels of the moderator, separately, within the Qlarity and usual care group (i.e., simple 
trajectories) using methods described by Curran (Curran, Bauer et al. 2006). 
 
Mediation effects. Growth-curve models implemented in an SEM framework will be used to 
explore whether observed condition effects on tobacco, alcohol, and drug use are mediated by 
adolescent attitudes and mindfulness. Following Preacher et al., models will be constructed by 
individually fitting growth models for mediators and outcomes using the growth curve model-
building sequence described above to develop the best longitudinal change model. Then mediator 
and outcome growth curves will be combined in a single model. We will test whether (a) condition 
predicts change in each mediator, (b) condition predicts change in each outcome, (c) mediator 
change predicts outcome change, and (d) the condition effect on the outcome is significantly 
weaker when controlling for level or change in the mediator. Significance of indirect effects will be 
tested using bias-corrected bootstrapped confidence intervals. 
 
Process analyses. A critical element to the program evaluation is the acceptability of the 
intervention to the target population, which will be assessed via rate of attrition, level of program 

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use, and degree of program satisfaction. Dose-response analyses will be conducted to examine the 
degree to which treatment engagement and retention (e.g., frequency and duration of app use, 
number of modules completed) predict change in the outcome measures at the post-intervention 
and follow-up assessments. Canonical correlation analyses will be used to examine the association 
between the dosage measures and outcome measures within the Qlarity condition. We will also 
test the hypothesis that those participants who report greater satisfaction with the intervention will 
have greater improvement in baseline-post scores using residual gain score analyses. Lastly, 
treating participant satisfaction as a process variable, we will examine the correlations between the 
satisfaction ratings and the amount of treatment engagement/retention. 
 
Missing data. Missing data in outcome measures may result from dropout or item non-response. 
The mixed- growth models described above make use of maximum likelihood estimates and allow 
for use of all available outcome data from all assessments, reducing bias and increasing power. In 
general, maximum likelihood procedures, as well as imputation methods, will be used as they can 
provide unbiased estimates even in instances of substantial attrition. Multiple imputation procedures 
will follow best-practice recommendations. 
Power considerations. The assumptions for the power estimates include a sample size of 380 
participants, Type II error rate of 20% (β = .20) and a 2-tailed alpha = .05. Power estimates for 
multilevel growth models require assumptions that are not easily established in longitudinal studies 
(e.g., complete data, homogeneous random-effects covariance structures within conditions). Thus 
we rely on the fact that power for multilevel growth models has been shown to surpass that of the 
mixed-model ANCOVA. The proposed growth models, then, will detect smaller differences between 
conditions than the ANCOVA models on which power estimates were based. Allowing for intent-to-
treat analyses that makes use of all available data using missing data techniques described above 
and a pretest covariate r2= .25, there is sufficient power to detect main effects for condition of 
Cohen’s d = .25 (small effect size) and detect condition by moderator effects of d = .35 (small to 
medium effect). The smallest subsample expected for decomposition of significant moderating 
effects is approximately 150 minority participants (75 per condition) which will provide sufficient 
power (>.80) to detect condition effects of d = .40 (medium effect). The study is also powered to 
detect small to medium between condition effect size differences (ORs = 2.05 – 2.25) for the logistic 
regression models predicting an estimated 15-20% substance use abstinence rates at follow-up. 
Using mediation effect size guidelines from Kenny for a model containing a dichotomous 
independent variable and a continuous mediator, effect sizes of .02, .15, and .40 derived from the 
product of d and r, represent small, medium, and large effect sizes respectively. 
Assuming small to moderate effects for the indirect pathway (r = .20), the proposed sample size 
has sufficient power (>.94) to detect small effect sizes or greater (dr = .04) for tests of mediation. 
Process analyses involving correlation coefficients will have adequate power to detect small to 
medium effects (r = .20). 
Feasibility benchmarks. Program feasibility will be demonstrated by the achievement of the 
following benchmarks: (a) significant pre-post increases (e.g., Cohen’s d > .35) in emotional 
regulation, mindfulness, and self-efficacy, (b) significantly greater decreases in alcohol, tobacco, 
and other drug use for Qlarity participants; (c) a high consistent level of app usage (e.g., over 70% 
of users used the app at least 12 times over the 12 weeks); and (d) a high degree of youth 
satisfaction and ratings of app acceptability and usability (mean ratings > 4.0 on the 5-point scale). 
Benchmarks are based on meta-analysis quantitative methods that recommend effect sizes of at 
least d >.25 to demonstrate educationally meaningful change; a desire to show at least an average 
of weekly app use by a majority of participants; and a level of participant satisfaction that meets or 
exceeds that of Phase I.