Skip to content

Mindfulness Mobile App to Reduce Adolescent Substance Use

Mindfulness Mobile App to Reduce Adolescent Substance Use

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04027075
Acronym
Qlarity
Enrollment
257
Registered
2019-07-19
Start date
2020-02-10
Completion date
2023-04-30
Last updated
2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Drinking, Adolescent Problem Behavior

Keywords

Adolescent, Alcohol, Marijuana, Mindfulness

Brief 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. 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.

Interventions

BEHAVIORALQlarity app users

Use of the Qlarity app involves completing 12 modules and 12 practice sessions over 30 days.

Sponsors

Oregon Research Behavioral Intervention Strategies, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* 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)

Exclusion criteria

* non-English speaking

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Marijuana UseBaseline, 3 monthsAn EZ Split Key 10 panel cup was used to detect marijuana in a urine sample.
Number of Participants With Prescribed Drugs UseBaseline, 3 monthsAn EZ Split Key 10 panel cup was used to detect prescribed drugs in a urine sample.
Number of Participants With Hard Drug UseBaseline, 3 monthsAn EZ Split Key 10 panel cup was used to detect hard drugs in a urine sample.
Change in Adolescent Use of CigarettesBaseline, 1 month, 3 monthsChange in nicotine use (frequency of use and amount consumed) as measured by Youth Substance Use Interview
Change in Adolescent Use of AlcoholBaseline, 1 month, 3 monthsChange in alcohol use (frequency of use and amount consumed) as measured by Youth Substance Use Interview
Change in Adolescent Use of MarijuanaBaseline, 1 month, 3 monthsChange in marijuana use (frequency of use and amount consumed) as measured by Youth Substance Use Interview
Change in Adolescent Use of Other Recreational SubstancesBaseline, 1 month, 3 monthsChange in use of hard drugs as measured by the Youth Substance Use Interview
Change in Ability to Limit Substance UseBaseline, 1 month, 3 monthsSelf-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 RegulationBaseline, 1 month, 3 monthsEmotion 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 SubscaleBaseline, 1 month, 3 monthsMindfulness 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 SubscaleBaseline, 1 month, 3 monthsMindfulness 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 SubscaleBaseline, 1 month, 2 monthsMindfulness 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 SubscaleBaseline, 1 month, 3 monthsMindfulness 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 SubscaleBaseline, 1 month, 3 monthsMindfulness 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 SubscaleBaseline, 1 month, 3 monthsChange 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 SubscaleBaseline, 1 month, 3 monthsChange 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention
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. Qlarity app users: Use of the Qlarity app involves completing 12 modules and 12 practice sessions over 30 days.
129
Services as Usual
This group will receive services as usual from the Department of Youth Services.
128
Total257

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up4122

Baseline characteristics

CharacteristicServices as UsualTotalIntervention
Age, Continuous15.23 years
STANDARD_DEVIATION 1.68
15.26 years
STANDARD_DEVIATION 1.64
15.30 years
STANDARD_DEVIATION 1.62
Race (NIH/OMB)
American Indian or Alaska Native
4 Participants8 Participants4 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Black or African American
14 Participants23 Participants9 Participants
Race (NIH/OMB)
More than one race
14 Participants26 Participants12 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
3 Participants3 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
11 Participants18 Participants7 Participants
Race (NIH/OMB)
White
81 Participants177 Participants96 Participants
Sex: Female, Male
Female
51 Participants101 Participants50 Participants
Sex: Female, Male
Male
77 Participants156 Participants79 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1290 / 128
other
Total, other adverse events
0 / 1290 / 128
serious
Total, serious adverse events
0 / 1290 / 128

Outcome results

Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
InterventionChange in Ability to Limit Substance UseBaseline46.60 units on a scaleStandard Deviation 11.72
InterventionChange in Ability to Limit Substance Use1 month47.08 units on a scaleStandard Deviation 12.63
InterventionChange in Ability to Limit Substance Use3 months44.36 units on a scaleStandard Deviation 13.84
Services as UsualChange in Ability to Limit Substance UseBaseline43.34 units on a scaleStandard Deviation 14.23
Services as UsualChange in Ability to Limit Substance Use1 month47.27 units on a scaleStandard Deviation 13.2
Services as UsualChange in Ability to Limit Substance Use3 months46.49 units on a scaleStandard Deviation 12.57
p-value: 0.005t-test, 2 sided
Primary

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
InterventionChange in Adolescent Use of AlcoholBaseline23 Participants
InterventionChange in Adolescent Use of Alcohol1 month10 Participants
InterventionChange in Adolescent Use of Alcohol3 months18 Participants
Services as UsualChange in Adolescent Use of AlcoholBaseline15 Participants
Services as UsualChange in Adolescent Use of Alcohol1 month12 Participants
Services as UsualChange in Adolescent Use of Alcohol3 months17 Participants
p-value: 0.6595% CI: [0.58, 2.42]Chi-squared
Primary

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
InterventionChange in Adolescent Use of Cigarettes3 month16 Participants
InterventionChange in Adolescent Use of CigarettesBaseline20 Participants
InterventionChange in Adolescent Use of Cigarettes1 month13 Participants
Services as UsualChange in Adolescent Use of Cigarettes3 month13 Participants
Services as UsualChange in Adolescent Use of CigarettesBaseline14 Participants
Services as UsualChange in Adolescent Use of Cigarettes1 month12 Participants
p-value: 0.68195% CI: [0.5, 2.87]Chi-squared
Primary

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
InterventionChange in Adolescent Use of MarijuanaBaseline52 Participants
InterventionChange in Adolescent Use of Marijuana1 month29 Participants
InterventionChange in Adolescent Use of Marijuana3 months40 Participants
Services as UsualChange in Adolescent Use of MarijuanaBaseline35 Participants
Services as UsualChange in Adolescent Use of Marijuana1 month35 Participants
Services as UsualChange in Adolescent Use of Marijuana3 months35 Participants
p-value: 0.30495% CI: [0.73, 2.73]Chi-squared
Primary

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
InterventionChange in Adolescent Use of Other Recreational SubstancesBaseline52 Participants
InterventionChange in Adolescent Use of Other Recreational Substances1 month16 Participants
InterventionChange in Adolescent Use of Other Recreational Substances3 months18 Participants
Services as UsualChange in Adolescent Use of Other Recreational SubstancesBaseline54 Participants
Services as UsualChange in Adolescent Use of Other Recreational Substances1 month17 Participants
Services as UsualChange in Adolescent Use of Other Recreational Substances3 months17 Participants
p-value: 0.9795% CI: [0.69, 3]Chi-squared
Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
InterventionChange in Attitudes Towards Substance Use - Lifestyle and Value Incompatibility SubscaleBaseline-0.04 units on a scaleStandard Deviation 0.57
InterventionChange in Attitudes Towards Substance Use - Lifestyle and Value Incompatibility Subscale1 month-0.01 units on a scaleStandard Deviation 0.6
InterventionChange in Attitudes Towards Substance Use - Lifestyle and Value Incompatibility Subscale3 months-0.04 units on a scaleStandard Deviation 0.56
Services as UsualChange in Attitudes Towards Substance Use - Lifestyle and Value Incompatibility SubscaleBaseline-0.01 units on a scaleStandard Deviation 0.65
Services as UsualChange in Attitudes Towards Substance Use - Lifestyle and Value Incompatibility Subscale1 month-0.02 units on a scaleStandard Deviation 0.6
Services as UsualChange in Attitudes Towards Substance Use - Lifestyle and Value Incompatibility Subscale3 months0.03 units on a scaleStandard Deviation 0.66
p-value: 0.783t-test, 2 sided
Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
InterventionChange in Attitude Toward Substance Use - Beliefs and Consequences SubscaleBaseline-0.04 units on a scaleStandard Deviation 0.45
InterventionChange in Attitude Toward Substance Use - Beliefs and Consequences Subscale1 month0.01 units on a scaleStandard Deviation 0.53
InterventionChange in Attitude Toward Substance Use - Beliefs and Consequences Subscale3 months-0.00 units on a scaleStandard Deviation 0.45
Services as UsualChange in Attitude Toward Substance Use - Beliefs and Consequences SubscaleBaseline0.05 units on a scaleStandard Deviation 0.47
Services as UsualChange in Attitude Toward Substance Use - Beliefs and Consequences Subscale1 month-0.01 units on a scaleStandard Deviation 0.49
Services as UsualChange in Attitude Toward Substance Use - Beliefs and Consequences Subscale3 months0.03 units on a scaleStandard Deviation 0.52
p-value: 0.658t-test, 2 sided
Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
InterventionChange in Emotion RegulationBaseline30.93 units on a scaleStandard Deviation 26.75
InterventionChange in Emotion Regulation1 month31.28 units on a scaleStandard Deviation 24.71
InterventionChange in Emotion Regulation3 months28.23 units on a scaleStandard Deviation 25.44
Services as UsualChange in Emotion RegulationBaseline30.38 units on a scaleStandard Deviation 25.88
Services as UsualChange in Emotion Regulation1 month34.87 units on a scaleStandard Deviation 24.05
Services as UsualChange in Emotion Regulation3 months30.31 units on a scaleStandard Deviation 25.89
p-value: 0.46t-test, 2 sided
Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
InterventionChange in Mindfulness Behavior - Acting With Awareness SubscaleBaseline21.86 units on a scaleStandard Deviation 5.88
InterventionChange in Mindfulness Behavior - Acting With Awareness Subscale1 month21.93 units on a scaleStandard Deviation 6.02
InterventionChange in Mindfulness Behavior - Acting With Awareness Subscale3 months22.49 units on a scaleStandard Deviation 5.73
Services as UsualChange in Mindfulness Behavior - Acting With Awareness SubscaleBaseline22.16 units on a scaleStandard Deviation 6.07
Services as UsualChange in Mindfulness Behavior - Acting With Awareness Subscale1 month23.38 units on a scaleStandard Deviation 6.16
Services as UsualChange in Mindfulness Behavior - Acting With Awareness Subscale3 months22.88 units on a scaleStandard Deviation 6.35
p-value: 0.456t-test, 2 sided
Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
InterventionChange in Mindfulness Behavior - Describing SubscaleBaseline24.14 units on a scaleStandard Deviation 5.45
InterventionChange in Mindfulness Behavior - Describing Subscale1 month23.63 units on a scaleStandard Deviation 6.15
InterventionChange in Mindfulness Behavior - Describing Subscale3 months24.22 units on a scaleStandard Deviation 5.68
Services as UsualChange in Mindfulness Behavior - Describing SubscaleBaseline23.39 units on a scaleStandard Deviation 5.61
Services as UsualChange in Mindfulness Behavior - Describing Subscale1 month23.26 units on a scaleStandard Deviation 5.81
Services as UsualChange in Mindfulness Behavior - Describing Subscale3 months23.41 units on a scaleStandard Deviation 5.67
p-value: 0.977t-test, 2 sided
Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
InterventionChange in Mindfulness Behavior - Non-judging of Inner Experience SubscaleBaseline25.62 units on a scaleStandard Deviation 6.98
InterventionChange in Mindfulness Behavior - Non-judging of Inner Experience Subscale1 month26.49 units on a scaleStandard Deviation 7.29
InterventionChange in Mindfulness Behavior - Non-judging of Inner Experience Subscale3 months25.57 units on a scaleStandard Deviation 7.65
Services as UsualChange in Mindfulness Behavior - Non-judging of Inner Experience Subscale3 months25.55 units on a scaleStandard Deviation 6.69
Services as UsualChange in Mindfulness Behavior - Non-judging of Inner Experience SubscaleBaseline25.53 units on a scaleStandard Deviation 7.26
Services as UsualChange in Mindfulness Behavior - Non-judging of Inner Experience Subscale1 month25.49 units on a scaleStandard Deviation 7.67
p-value: 0.874t-test, 2 sided
Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
InterventionChange in Mindfulness Behavior - Non-reactivity to Inner Experience SubscaleBaseline19.97 units on a scaleStandard Deviation 4.6
InterventionChange in Mindfulness Behavior - Non-reactivity to Inner Experience Subscale1 month20.21 units on a scaleStandard Deviation 5.16
InterventionChange in Mindfulness Behavior - Non-reactivity to Inner Experience Subscale2 month21.07 units on a scaleStandard Deviation 4.72
Services as UsualChange in Mindfulness Behavior - Non-reactivity to Inner Experience SubscaleBaseline19.72 units on a scaleStandard Deviation 4.56
Services as UsualChange in Mindfulness Behavior - Non-reactivity to Inner Experience Subscale1 month19.60 units on a scaleStandard Deviation 4.93
Services as UsualChange in Mindfulness Behavior - Non-reactivity to Inner Experience Subscale2 month19.59 units on a scaleStandard Deviation 4.71
p-value: 0.069t-test, 2 sided
Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
InterventionChange in Mindfulness Behavior - Observing SubscaleBaseline25.57 units on a scaleStandard Deviation 7.55
InterventionChange in Mindfulness Behavior - Observing SubscalePretest25.29 units on a scaleStandard Deviation 6.15
InterventionChange in Mindfulness Behavior - Observing SubscalePosttest25.91 units on a scaleStandard Deviation 5.74
Services as UsualChange in Mindfulness Behavior - Observing SubscaleBaseline25.18 units on a scaleStandard Deviation 5.9
Services as UsualChange in Mindfulness Behavior - Observing SubscalePretest24.98 units on a scaleStandard Deviation 6.03
Services as UsualChange in Mindfulness Behavior - Observing SubscalePosttest25.05 units on a scaleStandard Deviation 6.1
p-value: 0.851t-test, 2 sided
Primary

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants With Hard Drug UseBaseline22 Participants
InterventionNumber of Participants With Hard Drug Use3 months15 Participants
Services as UsualNumber of Participants With Hard Drug UseBaseline14 Participants
Services as UsualNumber of Participants With Hard Drug Use3 months14 Participants
p-value: 0.22795% CI: [0.75, 3.29]Chi-squared
Primary

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants With Marijuana UseBaseline47 Participants
InterventionNumber of Participants With Marijuana Use3 months41 Participants
Services as UsualNumber of Participants With Marijuana UseBaseline40 Participants
Services as UsualNumber of Participants With Marijuana Use3 months41 Participants
p-value: 0.96295% CI: [0.51, 2.02]Chi-squared
Primary

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants With Prescribed Drugs UseBaseline55 Participants
InterventionNumber of Participants With Prescribed Drugs Use3 months22 Participants
Services as UsualNumber of Participants With Prescribed Drugs UseBaseline46 Participants
Services as UsualNumber of Participants With Prescribed Drugs Use3 months27 Participants
p-value: 0.10995% CI: [0.19, 1.18]Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026