Mindfulness
Conditions
Keywords
Mindfulness
Brief summary
Randomized controlled trial comparing a coached, app-based mindfulness intervention versus a no-intervention control condition. Primary outcome: adolescents' reports of affect as measured with ecological momentary assessment (EMA) at post-intervention. Participants will include 120 youth ages 12-17 years old.
Detailed description
This is a randomized controlled trial testing a 9-session, coached, app-based mindfulness intervention on adolescents' reports of affect as measured with ecological momentary assessment (EMA). Participants will include 120 youth ages 12- to 17-years-old randomized to either the Youth Mindful Awareness Program (YMAP) or to an assessment only control condition. Participation is open to all genders and youth of all races and ethnicities.
Interventions
BEHAVIORALYouth Mindful Awareness Program (YMAP)
The Mindfulness Intervention is an internet-based program that involves a coach. It is 9 weekly sessions and involves practicing the skills between sessions.
Sponsors
Northwestern University
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors of outcomes will be masked to intervention condition
Intervention model description
Mindfulness vs. No intervention control
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* ages 12- to 17-years-old * has access to a smartphone, tablet, or other mobile device on which they can access the mindfulness app and complete EMA reports. Youth without a device will be provided with one for their time in the study.
Exclusion criteria
* current DSM5 diagnosis of an anxiety or depressive disorder with significant clinical impairment * current alcohol or substance use disorder; currently suicidal * lifetime diagnosis of bipolar disorder, schizophrenia, autism, conduct disorder, or developmental delay * reading level below 4th grade * not English speaking at a level that would allow them to participate in the intervention and assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Momentary Negative Affect Assessed With Ecological Momentary Assessment | 5 days | Momentary negative affect (mNA) in EMA is the experience of negative emotional states in the moment. Participants complete the Ecological Momentary Assessment (EMA) 4 times a day for 5 days, at random moments across the day (usually once in the morning, once in the early afternoon, once in the late afternoon and once in the evening). The EMA affect measure includes 7 items rated on a 4-point scale; average scores range from 1.00 to 4.00; higher scores indicate more negative affect (NA). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited through a university listserv, advertising on FaceBook and in subways (in Chicago), local schools, and community events. Recruitment began 05/15/2021
Pre-assignment details
After parents completed the consent form and the teen completed the assent form, the teen was interviewed regarding the inclusion and exclusion criteria (e.g., psychiatric symptoms and diagnoses).
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness Internet-based, coached Mindfulness Program. Nine weekly coached sessions with practice exercises between sessions.
Youth Mindful Awareness Program (YMAP): The Mindfulness Intervention is an internet-based program that involves a coach. It is 9 weekly sessions and involves practicing the skills between sessions. | 53 |
| Control Participants in this arm are randomly assigned to an assessment-only, no intervention control condition. | 57 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 7 |
Baseline characteristics
| Characteristic | Mindfulness | Total | Control |
|---|---|---|---|
| Age, Continuous | 14.13 years STANDARD_DEVIATION 1.68 | 14.17 years STANDARD_DEVIATION 1.6 | 14.20 years STANDARD_DEVIATION 1.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 36 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 74 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 10 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 24 Participants | 14 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 33 Participants | 68 Participants | 35 Participants |
| Region of Enrollment United States | 53 Participants | 110 Participants | 57 Participants |
| Sex: Female, Male Female | 36 Participants | 76 Participants | 40 Participants |
| Sex: Female, Male Male | 17 Participants | 34 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 57 |
| other Total, other adverse events | 0 / 53 | 0 / 57 |
| serious Total, serious adverse events | 0 / 53 | 0 / 57 |
Outcome results
Primary
Momentary Negative Affect Assessed With Ecological Momentary Assessment
Momentary negative affect (mNA) in EMA is the experience of negative emotional states in the moment. Participants complete the Ecological Momentary Assessment (EMA) 4 times a day for 5 days, at random moments across the day (usually once in the morning, once in the early afternoon, once in the late afternoon and once in the evening). The EMA affect measure includes 7 items rated on a 4-point scale; average scores range from 1.00 to 4.00; higher scores indicate more negative affect (NA).
Time frame: 5 days
Population: All 110 randomized participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness | Momentary Negative Affect Assessed With Ecological Momentary Assessment | -.17 score on a scale | Standard Deviation 1.39 |
| Control | Momentary Negative Affect Assessed With Ecological Momentary Assessment | .14 score on a scale | Standard Deviation 0.25 |
p-value: 0.04895% CI: [0.003, 0.085]Regression, Linear