Trial Outcomes & Findings for Mindfulness Mobile App to Reduce Adolescent Substance Use (NCT NCT04027075)
NCT ID: NCT04027075
Last Updated: 2024-12-12
Results Overview
An EZ Split Key 10 panel cup was used to detect marijuana in a urine sample.
COMPLETED
NA
257 participants
Baseline, 3 months
2024-12-12
Participant Flow
Participant milestones
| Measure |
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.
|
Services as Usual
This group will receive services as usual from the Department of Youth Services.
|
|---|---|---|
|
Overall Study
STARTED
|
129
|
128
|
|
Overall Study
COMPLETED
|
88
|
106
|
|
Overall Study
NOT COMPLETED
|
41
|
22
|
Reasons for withdrawal
| Measure |
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.
|
Services as Usual
This group will receive services as usual from the Department of Youth Services.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
41
|
22
|
Baseline Characteristics
Mindfulness Mobile App to Reduce Adolescent Substance Use
Baseline characteristics by cohort
| Measure |
Intervention
n=129 Participants
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.
|
Services as Usual
n=128 Participants
This group will receive services as usual from the Department of Youth Services.
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.30 years
STANDARD_DEVIATION 1.62 • n=5 Participants
|
15.23 years
STANDARD_DEVIATION 1.68 • n=7 Participants
|
15.26 years
STANDARD_DEVIATION 1.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
96 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsAn EZ Split Key 10 panel cup was used to detect marijuana in a urine sample.
Outcome measures
| Measure |
Intervention
n=129 Participants
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.
|
Services as Usual
n=128 Participants
This group will receive services as usual from the Department of Youth Services.
|
|---|---|---|
|
Number of Participants With Marijuana Use
Baseline
|
47 Participants
|
40 Participants
|
|
Number of Participants With Marijuana Use
3 months
|
41 Participants
|
41 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsAn EZ Split Key 10 panel cup was used to detect prescribed drugs in a urine sample.
Outcome measures
| Measure |
Intervention
n=129 Participants
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.
|
Services as Usual
n=128 Participants
This group will receive services as usual from the Department of Youth Services.
|
|---|---|---|
|
Number of Participants With Prescribed Drugs Use
Baseline
|
55 Participants
|
46 Participants
|
|
Number of Participants With Prescribed Drugs Use
3 months
|
22 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsAn EZ Split Key 10 panel cup was used to detect hard drugs in a urine sample.
Outcome measures
| Measure |
Intervention
n=129 Participants
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.
|
Services as Usual
n=128 Participants
This group will receive services as usual from the Department of Youth Services.
|
|---|---|---|
|
Number of Participants With Hard Drug Use
Baseline
|
22 Participants
|
14 Participants
|
|
Number of Participants With Hard Drug Use
3 months
|
15 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 month, 3 monthsChange in nicotine use (frequency of use and amount consumed) as measured by Youth Substance Use Interview
Outcome measures
| Measure |
Intervention
n=129 Participants
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.
|
Services as Usual
n=128 Participants
This group will receive services as usual from the Department of Youth Services.
|
|---|---|---|
|
Change in Adolescent Use of Cigarettes
Baseline
|
20 Participants
|
14 Participants
|
|
Change in Adolescent Use of Cigarettes
1 month
|
13 Participants
|
12 Participants
|
|
Change in Adolescent Use of Cigarettes
3 month
|
16 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 month, 3 monthsChange in alcohol use (frequency of use and amount consumed) as measured by Youth Substance Use Interview
Outcome measures
| Measure |
Intervention
n=129 Participants
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.
|
Services as Usual
n=128 Participants
This group will receive services as usual from the Department of Youth Services.
|
|---|---|---|
|
Change in Adolescent Use of Alcohol
Baseline
|
23 Participants
|
15 Participants
|
|
Change in Adolescent Use of Alcohol
1 month
|
10 Participants
|
12 Participants
|
|
Change in Adolescent Use of Alcohol
3 months
|
18 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 month, 3 monthsChange in marijuana use (frequency of use and amount consumed) as measured by Youth Substance Use Interview
Outcome measures
| Measure |
Intervention
n=129 Participants
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.
|
Services as Usual
n=128 Participants
This group will receive services as usual from the Department of Youth Services.
|
|---|---|---|
|
Change in Adolescent Use of Marijuana
Baseline
|
52 Participants
|
35 Participants
|
|
Change in Adolescent Use of Marijuana
1 month
|
29 Participants
|
35 Participants
|
|
Change in Adolescent Use of Marijuana
3 months
|
40 Participants
|
35 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 month, 3 monthsChange in use of hard drugs as measured by the Youth Substance Use Interview
Outcome measures
| Measure |
Intervention
n=129 Participants
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.
|
Services as Usual
n=128 Participants
This group will receive services as usual from the Department of Youth Services.
|
|---|---|---|
|
Change in Adolescent Use of Other Recreational Substances
Baseline
|
52 Participants
|
54 Participants
|
|
Change in Adolescent Use of Other Recreational Substances
1 month
|
16 Participants
|
17 Participants
|
|
Change in Adolescent Use of Other Recreational Substances
3 months
|
18 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Baseline, 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
Outcome measures
| Measure |
Intervention
n=129 Participants
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.
|
Services as Usual
n=128 Participants
This group will receive services as usual from the Department of Youth Services.
|
|---|---|---|
|
Change in Ability to Limit Substance Use
Baseline
|
46.60 units on a scale
Standard Deviation 11.72
|
43.34 units on a scale
Standard Deviation 14.23
|
|
Change in Ability to Limit Substance Use
1 month
|
47.08 units on a scale
Standard Deviation 12.63
|
47.27 units on a scale
Standard Deviation 13.20
|
|
Change in Ability to Limit Substance Use
3 months
|
44.36 units on a scale
Standard Deviation 13.84
|
46.49 units on a scale
Standard Deviation 12.57
|
PRIMARY outcome
Timeframe: Baseline, 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.
Outcome measures
| Measure |
Intervention
n=129 Participants
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.
|
Services as Usual
n=128 Participants
This group will receive services as usual from the Department of Youth Services.
|
|---|---|---|
|
Change in Emotion Regulation
Baseline
|
30.93 units on a scale
Standard Deviation 26.75
|
30.38 units on a scale
Standard Deviation 25.88
|
|
Change in Emotion Regulation
1 month
|
31.28 units on a scale
Standard Deviation 24.71
|
34.87 units on a scale
Standard Deviation 24.05
|
|
Change in Emotion Regulation
3 months
|
28.23 units on a scale
Standard Deviation 25.44
|
30.31 units on a scale
Standard Deviation 25.89
|
PRIMARY outcome
Timeframe: Baseline, 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.
Outcome measures
| Measure |
Intervention
n=129 Participants
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.
|
Services as Usual
n=128 Participants
This group will receive services as usual from the Department of Youth Services.
|
|---|---|---|
|
Change in Mindfulness Behavior - Observing Subscale
Baseline
|
25.57 units on a scale
Standard Deviation 7.55
|
25.18 units on a scale
Standard Deviation 5.90
|
|
Change in Mindfulness Behavior - Observing Subscale
Pretest
|
25.29 units on a scale
Standard Deviation 6.15
|
24.98 units on a scale
Standard Deviation 6.03
|
|
Change in Mindfulness Behavior - Observing Subscale
Posttest
|
25.91 units on a scale
Standard Deviation 5.74
|
25.05 units on a scale
Standard Deviation 6.10
|
PRIMARY outcome
Timeframe: Baseline, 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.
Outcome measures
| Measure |
Intervention
n=129 Participants
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.
|
Services as Usual
n=128 Participants
This group will receive services as usual from the Department of Youth Services.
|
|---|---|---|
|
Change in Mindfulness Behavior - Describing Subscale
Baseline
|
24.14 units on a scale
Standard Deviation 5.45
|
23.39 units on a scale
Standard Deviation 5.61
|
|
Change in Mindfulness Behavior - Describing Subscale
1 month
|
23.63 units on a scale
Standard Deviation 6.15
|
23.26 units on a scale
Standard Deviation 5.81
|
|
Change in Mindfulness Behavior - Describing Subscale
3 months
|
24.22 units on a scale
Standard Deviation 5.68
|
23.41 units on a scale
Standard Deviation 5.67
|
PRIMARY outcome
Timeframe: Baseline, 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.
Outcome measures
| Measure |
Intervention
n=129 Participants
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.
|
Services as Usual
n=128 Participants
This group will receive services as usual from the Department of Youth Services.
|
|---|---|---|
|
Change in Mindfulness Behavior - Acting With Awareness Subscale
Baseline
|
21.86 units on a scale
Standard Deviation 5.88
|
22.16 units on a scale
Standard Deviation 6.07
|
|
Change in Mindfulness Behavior - Acting With Awareness Subscale
1 month
|
21.93 units on a scale
Standard Deviation 6.02
|
23.38 units on a scale
Standard Deviation 6.16
|
|
Change in Mindfulness Behavior - Acting With Awareness Subscale
3 months
|
22.49 units on a scale
Standard Deviation 5.73
|
22.88 units on a scale
Standard Deviation 6.35
|
PRIMARY outcome
Timeframe: Baseline, 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.
Outcome measures
| Measure |
Intervention
n=129 Participants
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.
|
Services as Usual
n=128 Participants
This group will receive services as usual from the Department of Youth Services.
|
|---|---|---|
|
Change in Mindfulness Behavior - Non-judging of Inner Experience Subscale
Baseline
|
25.62 units on a scale
Standard Deviation 6.98
|
25.53 units on a scale
Standard Deviation 7.26
|
|
Change in Mindfulness Behavior - Non-judging of Inner Experience Subscale
1 month
|
26.49 units on a scale
Standard Deviation 7.29
|
25.49 units on a scale
Standard Deviation 7.67
|
|
Change in Mindfulness Behavior - Non-judging of Inner Experience Subscale
3 months
|
25.57 units on a scale
Standard Deviation 7.65
|
25.55 units on a scale
Standard Deviation 6.69
|
PRIMARY outcome
Timeframe: Baseline, 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.
Outcome measures
| Measure |
Intervention
n=129 Participants
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.
|
Services as Usual
n=128 Participants
This group will receive services as usual from the Department of Youth Services.
|
|---|---|---|
|
Change in Mindfulness Behavior - Non-reactivity to Inner Experience Subscale
Baseline
|
19.97 units on a scale
Standard Deviation 4.60
|
19.72 units on a scale
Standard Deviation 4.56
|
|
Change in Mindfulness Behavior - Non-reactivity to Inner Experience Subscale
1 month
|
20.21 units on a scale
Standard Deviation 5.16
|
19.60 units on a scale
Standard Deviation 4.93
|
|
Change in Mindfulness Behavior - Non-reactivity to Inner Experience Subscale
2 month
|
21.07 units on a scale
Standard Deviation 4.72
|
19.59 units on a scale
Standard Deviation 4.71
|
PRIMARY outcome
Timeframe: Baseline, 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.
Outcome measures
| Measure |
Intervention
n=129 Participants
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.
|
Services as Usual
n=128 Participants
This group will receive services as usual from the Department of Youth Services.
|
|---|---|---|
|
Change in Attitude Toward Substance Use - Beliefs and Consequences Subscale
Baseline
|
-0.04 units on a scale
Standard Deviation 0.45
|
0.05 units on a scale
Standard Deviation 0.47
|
|
Change in Attitude Toward Substance Use - Beliefs and Consequences Subscale
1 month
|
0.01 units on a scale
Standard Deviation 0.53
|
-0.01 units on a scale
Standard Deviation 0.49
|
|
Change in Attitude Toward Substance Use - Beliefs and Consequences Subscale
3 months
|
-0.00 units on a scale
Standard Deviation 0.45
|
0.03 units on a scale
Standard Deviation 0.52
|
PRIMARY outcome
Timeframe: Baseline, 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.
Outcome measures
| Measure |
Intervention
n=129 Participants
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.
|
Services as Usual
n=128 Participants
This group will receive services as usual from the Department of Youth Services.
|
|---|---|---|
|
Change in Attitudes Towards Substance Use - Lifestyle and Value Incompatibility Subscale
Baseline
|
-0.04 units on a scale
Standard Deviation 0.57
|
-0.01 units on a scale
Standard Deviation 0.65
|
|
Change in Attitudes Towards Substance Use - Lifestyle and Value Incompatibility Subscale
1 month
|
-0.01 units on a scale
Standard Deviation 0.60
|
-0.02 units on a scale
Standard Deviation 0.60
|
|
Change in Attitudes Towards Substance Use - Lifestyle and Value Incompatibility Subscale
3 months
|
-0.04 units on a scale
Standard Deviation 0.56
|
0.03 units on a scale
Standard Deviation 0.66
|
Adverse Events
Intervention
Services as Usual
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dana Smith
Oregon Research Behavioral Intervention Strategies, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place