Adolescent DrinkingQlarityNCT04027075
Mindfulness Mobile App to Reduce Adolescent Substance Use
A study testing Qlarity app users in people with Adolescent Drinking and Adolescent Problem Behavior, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Drinking, Adolescent Problem Behavior
- What is being tested?
- Qlarity app users
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- any gender, age 13-18
- recent involvement with juvenile justice system
- documented substance use
- English speaking
- living in the community (e.g., with biological/adoptive/foster parents)
Who cannot join
- non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Research Behavioral Intervention Strategies, Inc.
Springfield, Oregon, 97477
About this study
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.
Read the detailed description
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.
- Conditions
- Adolescent Drinking, Adolescent Problem Behavior
- Being tested
- Qlarity app users
- Keywords
- Adolescent, Alcohol, Marijuana, Mindfulness
- Medical subject headings
- Underage Drinking, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qlarity app usersBehavioural
Use of the Qlarity app involves completing 12 modules and 12 practice sessions over 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Qlarity app users |
| Services as usual | No intervention | This group will receive services as usual from the Department of Youth Services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Marijuana Use
An EZ Split Key 10 panel cup was used to detect marijuana in a urine sample.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start10 Feb 2020
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adolescent DrinkingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will recruit 400 adolescents to test an app designed to increase mindfulness skills and reduce substance use. Participants will be randomly assigned in equal numbers to the intervention group (and will use the app) or the control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dana Smith, PhD, Principal investigator, Oregon Research Behavioral Intervention Strategies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027075
- Sponsor's protocol ID
- DA043288-02
- Acronym
- Qlarity
- Status last verified
- Dec 2024
- First submitted
- 17 Jul 2019
- Last updated
- 12 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Mobile App to Reduce Adolescent Substance Use
- ClinicalTrials.gov ID
- NCT04027075
- Acronym / sponsor ID
- Qlarity / DA043288-02
- Conditions
- Adolescent Drinking, Adolescent Problem Behavior
- Keywords
- Adolescent, Alcohol, Marijuana, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Posted 12 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will recruit 400 adolescents to test an app designed to increase mindfulness skills and reduce substance use. Participants will be randomly assigned in equal numbers to the intervention group (and will use the app) or the control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Qlarity app usersThis 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. |
| Services as usual | No intervention | –This group will receive services as usual from the Department of Youth Services. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- any gender, age 13-18
- recent involvement with juvenile justice system
- documented substance use
- English speaking
- living in the community (e.g., with biological/adoptive/foster parents)
Key exclusion criteria (1 listed)
- non-English speaking
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 |
|---|---|---|
| Qlarity app usersUse of the Qlarity app involves completing 12 modules and 12 practice sessions over 30 days. | Behavioural | Intervention |
Primary outcome
Number of Participants With Marijuana Use
Time frame: Baseline, 3 months
An EZ Split Key 10 panel cup was used to detect marijuana in a urine sample.
Number of Participants With Prescribed Drugs Use
Time frame: Baseline, 3 months
An EZ Split Key 10 panel cup was used to detect prescribed drugs in a urine sample.
Number of Participants With Hard Drug Use
Time frame: Baseline, 3 months
An EZ Split Key 10 panel cup was used to detect hard drugs in a urine sample.
Change in Adolescent Use of Cigarettes
Time frame: Baseline, 1 month, 3 months
Change in nicotine use (frequency of use and amount consumed) as measured by Youth Substance Use Interview
Change in Adolescent Use of Alcohol
Time frame: Baseline, 1 month, 3 months
Change in alcohol use (frequency of use and amount consumed) as measured by Youth Substance Use Interview
Change in Adolescent Use of Marijuana
Time frame: Baseline, 1 month, 3 months
Change in marijuana use (frequency of use and amount consumed) as measured by Youth Substance Use Interview
Change in Adolescent Use of Other Recreational Substances
Time frame: Baseline, 1 month, 3 months
Change in use of hard drugs as measured by the Youth Substance Use Interview
Change in Ability to Limit Substance Use
Time frame: Baseline, 1 month, 3 months
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
Change in Emotion Regulation
Time frame: Baseline, 1 month, 3 months
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.
Change in Mindfulness Behavior - Observing Subscale
Time frame: Baseline, 1 month, 3 months
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.
Change in Mindfulness Behavior - Describing Subscale
Time frame: Baseline, 1 month, 3 months
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.
Change in Mindfulness Behavior - Acting With Awareness Subscale
Time frame: Baseline, 1 month, 2 months
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.
Change in Mindfulness Behavior - Non-judging of Inner Experience Subscale
Time frame: Baseline, 1 month, 3 months
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.
Change in Mindfulness Behavior - Non-reactivity to Inner Experience Subscale
Time frame: Baseline, 1 month, 3 months
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.
Change in Attitude Toward Substance Use - Beliefs and Consequences Subscale
Time frame: Baseline, 1 month, 3 months
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.
Change in Attitudes Towards Substance Use - Lifestyle and Value Incompatibility Subscale
Time frame: Baseline, 1 month, 3 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Dana Smith, PhD principal investigator
Oregon Research Behavioral Intervention Strategies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qlarity app users in people with Adolescent Drinking and Adolescent Problem Behavior, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 12 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Marijuana Use (time frame: Baseline, 3 months). The study lists 16 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 12 Dec 2024.