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Trial Outcomes & Findings for Testing the Effect of the Youth Mindful Awareness Program on Negative Affect (NCT NCT04718129)

NCT ID: NCT04718129

Last Updated: 2025-04-01

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

110 participants

Primary outcome timeframe

5 days

Results posted on

2025-04-01

Participant Flow

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

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).

Participant milestones

Participant milestones
Measure
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.
Control
Participants in this arm are randomly assigned to an assessment-only, no intervention control condition.
Overall Study
STARTED
53
57
Overall Study
COMPLETED
47
50
Overall Study
NOT COMPLETED
6
7

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
Control
Participants in this arm are randomly assigned to an assessment-only, no intervention control condition.
Overall Study
Lost to Follow-up
6
7

Baseline Characteristics

Testing the Effect of the Youth Mindful Awareness Program on Negative Affect

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Mindfulness
n=53 Participants
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.
Control
n=57 Participants
Participants in this arm are randomly assigned to an assessment-only, no intervention control condition.
Total
n=110 Participants
Total of all reporting groups
Age, Continuous
14.13 years
STANDARD_DEVIATION 1.68 • n=5 Participants
14.20 years
STANDARD_DEVIATION 1.53 • n=7 Participants
14.17 years
STANDARD_DEVIATION 1.60 • n=5 Participants
Sex: Female, Male
Female
36 Participants
n=5 Participants
40 Participants
n=7 Participants
76 Participants
n=5 Participants
Sex: Female, Male
Male
17 Participants
n=5 Participants
17 Participants
n=7 Participants
34 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
20 Participants
n=5 Participants
16 Participants
n=7 Participants
36 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
33 Participants
n=5 Participants
41 Participants
n=7 Participants
74 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
2 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
7 Participants
n=5 Participants
3 Participants
n=7 Participants
10 Participants
n=5 Participants
Race (NIH/OMB)
White
33 Participants
n=5 Participants
35 Participants
n=7 Participants
68 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
10 Participants
n=5 Participants
14 Participants
n=7 Participants
24 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Region of Enrollment
United States
53 Participants
n=5 Participants
57 Participants
n=7 Participants
110 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 5 days

Population: All 110 randomized participants

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).

Outcome measures

Outcome measures
Measure
Mindfulness
n=53 Participants
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.
Control
n=57 Participants
Participants in this arm are randomly assigned to an assessment-only, no intervention control condition.
Momentary Negative Affect Assessed With Ecological Momentary Assessment
-.17 score on a scale
Standard Deviation 1.39
.14 score on a scale
Standard Deviation .25

Adverse Events

Mindfulness

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

Vanderbilt University

Phone: 615-330-5605

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place