An interventional study of Qlarity app users in Adolescent Drinking and Adolescent Problem Behavior, sponsored by Oregon Research Behavioral Intervention Strategies, Inc.. Completed at 1 site in United States. Open to participants aged 13 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by Oregon Research Behavioral Intervention Strategies, Inc. (part of Influents Innovations) · Not applicable, Interventional, and Treatment
Substance-abusing youth - especially those who are involved in the juvenile justice system - are at higher risk than nonusers for mental health problems, including depression, conduct problems, personality disorders, suicidal thoughts, attempted suicide, and completed suicide. The proposed Phase II project aims to develop and test the efficacy of a mobile app, called Qlarity, that is geared toward helping high risk adolescent substance users reduce or quit their substance use. The Qlarity app is based on the primary substance use cessation components tested in our previous work with juvenile justice-involved adolescents and on intervention components shown to be central to smoking cessation; it applies a mindfulness approach as the guiding framework for the intervention.
There is growing evidence that interventions based on mindfulness have been an efficacious intervention for a variety of problems, including substance use among adolescents. We propose to adapt and test the feasibility and efficacy of a smart phone application (app) intervention prototype that would help adolescent substance users reduce or quit their substance use through the development of stress reduction, emotion regulation, and mindfulness skills. During the development process, 20 high-risk adolescents will be recruited for participation in focus groups and usability testing of early versions of the app; their initial reactions to content and functionality will help guide final iterations. Qlarity is a twelve module program, and each module consists of a teaching component and a practice component. Modules take 5 minutes or less to complete. Module topics include developing an awareness of mind and body states, mindful decision making, and maintaining sobriety.
In this study, the Qlarity app will be evaluated with 400 high risk adolescents that are involved in the juvenile justice system; the first 20 adolescents will be involved in the development process and the remaining 380 participants will be randomly and equally assigned to the Qlarity condition (n = 190) or the Department of Youth Services standard treatment condition (n = 190). Youth will be assessed at baseline and will be instructed to attempt to reduce substance use with a target quit date of 28 days in the future. The Qlarity group will receive instructions for using the app in the 28 days following baseline. All youth will complete 1 and 3 month follow-ups. Assessments will consist of online surveys asking about substance use, emotion regulation, family demographics, and mindfulness practices. The Qlarity group will also be asked for their thoughts and opinions on the app. Biochemical verification of self-reported substance use, a urine sample, will be collected at each interview.
44 studies on the registry are indexed under Underage Drinking; 13 are open to participants now.
This study's enrollment of 257 is below the median of 360 across 43 interventional studies indexed under Underage Drinking.
Browse Underage Drinking studies →Oregon Research Behavioral Intervention Strategies, Inc. is the lead sponsor of 24 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
This group will be asked to use the Qlarity app daily in the month following the baseline assessment. This group will also receive services as usual from the Department of Youth Services.
Behavioral: Qlarity app users
This group will receive services as usual from the Department of Youth Services.
Use of the Qlarity app involves completing 12 modules and 12 practice sessions over 30 days.
Number of Participants With Marijuana Use
An EZ Split Key 10 panel cup was used to detect marijuana in a urine sample.
Time frame: Baseline, 3 months
Number of Participants With Prescribed Drugs Use
An EZ Split Key 10 panel cup was used to detect prescribed drugs in a urine sample.
Time frame: Baseline, 3 months
Number of Participants With Hard Drug Use
An EZ Split Key 10 panel cup was used to detect hard drugs in a urine sample.
Time frame: Baseline, 3 months
Change in Adolescent Use of Cigarettes
Change in nicotine use (frequency of use and amount consumed) as measured by Youth Substance Use Interview
Time frame: Baseline, 1 month, 3 months
Change in Adolescent Use of Alcohol
Change in alcohol use (frequency of use and amount consumed) as measured by Youth Substance Use Interview
Time frame: Baseline, 1 month, 3 months
Change in Adolescent Use of Marijuana
Change in marijuana use (frequency of use and amount consumed) as measured by Youth Substance Use Interview
Time frame: Baseline, 1 month, 3 months
Change in Adolescent Use of Other Recreational Substances
Change in use of hard drugs as measured by the Youth Substance Use Interview
Time frame: Baseline, 1 month, 3 months
Change in Ability to Limit Substance Use
Self-efficacy for limiting substance use consists of 6 items that assess the ability to abstain from drug use. Response options range from 0 = cannot do at all to 10 = certainly can do. A sum score was computed and thus, values can range between 0 and 60. Higher scores indicate greater ability to abstain
Time frame: Baseline, 1 month, 3 months
Change in Emotion Regulation
Emotion Regulation is measured by the Difficulties in Emotion Regulation Scale. Emotional regulation was assessed with a 5-point response option (1 = almost never, 5 = almost always). A sum score was computed and thus, values can range between 1 and 55. A higher score indicates greater levels of emotional regulation.
Time frame: Baseline, 1 month, 3 months
Change in Mindfulness Behavior - Observing Subscale
Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.
Time frame: Baseline, 1 month, 3 months
Change in Mindfulness Behavior - Describing Subscale
Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.
Time frame: Baseline, 1 month, 3 months
Change in Mindfulness Behavior - Acting With Awareness Subscale
Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.
Time frame: Baseline, 1 month, 2 months
Change in Mindfulness Behavior - Non-judging of Inner Experience Subscale
Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.
Time frame: Baseline, 1 month, 3 months
Change in Mindfulness Behavior - Non-reactivity to Inner Experience Subscale
Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.
Time frame: Baseline, 1 month, 3 months
Change in Attitude Toward Substance Use - Beliefs and Consequences Subscale
Change in attitude related to drug use is measured with Adolescent Attitudes toward Substance Use. Subscales are (1) Beliefs and Consequences (9 items) and (2) Lifestyle and Value incompatibility (5 items). Response options were 0 to 10. Standardized scores were computed and values could range from -2.0 to 2.0. Higher scores represent more prosocial attitudes.
Time frame: Baseline, 1 month, 3 months
Change in Attitudes Towards Substance Use - Lifestyle and Value Incompatibility Subscale
Change in attitude related to drug use is measured with Adolescent Attitudes toward Substance Use. Subscales are (1) Beliefs and Consequences (9 items) and (2) Lifestyle and Value incompatibility (5 items). Response options were 0 to 10. Standardized scores were computed and values could range from -2.0 to 2.0. Higher scores represent more prosocial attitudes.
Time frame: Baseline, 1 month, 3 months
| Milestone | Intervention | Services as Usual |
|---|---|---|
| Started | 129 | 128 |
| Completed | 88 | 106 |
| Not completed | 41 | 22 |
| Withdrew: Lost to follow-up | 41 | 22 |
An EZ Split Key 10 panel cup was used to detect marijuana in a urine sample.
| Participants | Intervention | Services as Usual |
|---|---|---|
| Baseline | 47 | 40 |
| 3 months | 41 | 41 |
An EZ Split Key 10 panel cup was used to detect prescribed drugs in a urine sample.
| Participants | Intervention | Services as Usual |
|---|---|---|
| Baseline | 55 | 46 |
| 3 months | 22 | 27 |
An EZ Split Key 10 panel cup was used to detect hard drugs in a urine sample.
| Participants | Intervention | Services as Usual |
|---|---|---|
| Baseline | 22 | 14 |
| 3 months | 15 | 14 |
Change in nicotine use (frequency of use and amount consumed) as measured by Youth Substance Use Interview
| Participants | Intervention | Services as Usual |
|---|---|---|
| Baseline | 20 | 14 |
| 1 month | 13 | 12 |
| 3 month | 16 | 13 |
Change in alcohol use (frequency of use and amount consumed) as measured by Youth Substance Use Interview
| Participants | Intervention | Services as Usual |
|---|---|---|
| Baseline | 23 | 15 |
| 1 month | 10 | 12 |
| 3 months | 18 | 17 |
Change in marijuana use (frequency of use and amount consumed) as measured by Youth Substance Use Interview
| Participants | Intervention | Services as Usual |
|---|---|---|
| Baseline | 52 | 35 |
| 1 month | 29 | 35 |
| 3 months | 40 | 35 |
Change in use of hard drugs as measured by the Youth Substance Use Interview
| Participants | Intervention | Services as Usual |
|---|---|---|
| Baseline | 52 | 54 |
| 1 month | 16 | 17 |
| 3 months | 18 | 17 |
Self-efficacy for limiting substance use consists of 6 items that assess the ability to abstain from drug use. Response options range from 0 = cannot do at all to 10 = certainly can do. A sum score was computed and thus, values can range between 0 and 60. Higher scores indicate greater ability to abstain
| units on a scale | Intervention | Services as Usual |
|---|---|---|
| Baseline | 46.60 ± 11.72 | 43.34 ± 14.23 |
| 1 month | 47.08 ± 12.63 | 47.27 ± 13.20 |
| 3 months | 44.36 ± 13.84 | 46.49 ± 12.57 |
Emotion Regulation is measured by the Difficulties in Emotion Regulation Scale. Emotional regulation was assessed with a 5-point response option (1 = almost never, 5 = almost always). A sum score was computed and thus, values can range between 1 and 55. A higher score indicates greater levels of emotional regulation.
| units on a scale | Intervention | Services as Usual |
|---|---|---|
| Baseline | 30.93 ± 26.75 | 30.38 ± 25.88 |
| 1 month | 31.28 ± 24.71 | 34.87 ± 24.05 |
| 3 months | 28.23 ± 25.44 | 30.31 ± 25.89 |
Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.
| units on a scale | Intervention | Services as Usual |
|---|---|---|
| Baseline | 25.57 ± 7.55 | 25.18 ± 5.90 |
| Pretest | 25.29 ± 6.15 | 24.98 ± 6.03 |
| Posttest | 25.91 ± 5.74 | 25.05 ± 6.10 |
Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.
| units on a scale | Intervention | Services as Usual |
|---|---|---|
| Baseline | 24.14 ± 5.45 | 23.39 ± 5.61 |
| 1 month | 23.63 ± 6.15 | 23.26 ± 5.81 |
| 3 months | 24.22 ± 5.68 | 23.41 ± 5.67 |
Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.
| units on a scale | Intervention | Services as Usual |
|---|---|---|
| Baseline | 21.86 ± 5.88 | 22.16 ± 6.07 |
| 1 month | 21.93 ± 6.02 | 23.38 ± 6.16 |
| 3 months | 22.49 ± 5.73 | 22.88 ± 6.35 |
Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.
| units on a scale | Intervention | Services as Usual |
|---|---|---|
| Baseline | 25.62 ± 6.98 | 25.53 ± 7.26 |
| 1 month | 26.49 ± 7.29 | 25.49 ± 7.67 |
| 3 months | 25.57 ± 7.65 | 25.55 ± 6.69 |
Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.
| units on a scale | Intervention | Services as Usual |
|---|---|---|
| Baseline | 19.97 ± 4.60 | 19.72 ± 4.56 |
| 1 month | 20.21 ± 5.16 | 19.60 ± 4.93 |
| 2 month | 21.07 ± 4.72 | 19.59 ± 4.71 |
Change in attitude related to drug use is measured with Adolescent Attitudes toward Substance Use. Subscales are (1) Beliefs and Consequences (9 items) and (2) Lifestyle and Value incompatibility (5 items). Response options were 0 to 10. Standardized scores were computed and values could range from -2.0 to 2.0. Higher scores represent more prosocial attitudes.
| units on a scale | Intervention | Services as Usual |
|---|---|---|
| Baseline | -0.04 ± 0.45 | 0.05 ± 0.47 |
| 1 month | 0.01 ± 0.53 | -0.01 ± 0.49 |
| 3 months | -0.00 ± 0.45 | 0.03 ± 0.52 |
Change in attitude related to drug use is measured with Adolescent Attitudes toward Substance Use. Subscales are (1) Beliefs and Consequences (9 items) and (2) Lifestyle and Value incompatibility (5 items). Response options were 0 to 10. Standardized scores were computed and values could range from -2.0 to 2.0. Higher scores represent more prosocial attitudes.
| units on a scale | Intervention | Services as Usual |
|---|---|---|
| Baseline | -0.04 ± 0.57 | -0.01 ± 0.65 |
| 1 month | -0.01 ± 0.60 | -0.02 ± 0.60 |
| 3 months | -0.04 ± 0.56 | 0.03 ± 0.66 |
Collected over Adverse events were monitored over the 3 month period that participants were involved in the study. Data was assessed for adverse events at all data collection timepoints: baseline, 1 month follow up, and 3 month follow up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/129 (0%) | 0/129 (0%) | 0/129 (0%) |
| Services as Usual | 0/128 (0%) | 0/128 (0%) | 0/128 (0%) |
| Age, Continuous(years) | Intervention | Services as Usual | Total |
|---|---|---|---|
| Mean | 15.30 ± 1.62 | 15.23 ± 1.68 | 15.26 ± 1.64 |
| Sex: Female, Male(Participants) | Intervention | Services as Usual | Total |
|---|---|---|---|
| Female | 50 | 51 | 101 |
| Male | 79 | 77 | 156 |
| Race (NIH/OMB)(Participants) | Intervention | Services as Usual | Total |
|---|---|---|---|
| American Indian or Alaska Native | 4 | 4 | 8 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 3 | 3 |
| Black or African American | 9 | 14 | 23 |
| White | 96 | 81 | 177 |
| More than one race | 12 | 14 | 26 |
| Unknown or Not Reported | 7 | 11 | 18 |
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