MindfulnessYMAPNCT04718129
Testing the Effect of the Youth Mindful Awareness Program on Negative Affect
A study testing Youth Mindful Awareness Program (YMAP) in people with Mindfulness, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindfulness
- What is being tested?
- Youth Mindful Awareness Program (YMAP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2021to 5 Jul 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting Negative Affect Through Mindfulness Training in Youth at Risk for Internalizing Problems - R61
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.
Read the 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.
- Conditions
- Mindfulness
- Being tested
- Youth Mindful Awareness Program (YMAP)
- Keywords
- Mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youth Mindful Awareness Program (YMAP)Behavioural
The Mindfulness Intervention is an internet-based program that involves a coach. It is 9 weekly sessions and involves practicing the skills between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Internet-based, coached Mindfulness Program. Nine weekly coached sessions with practice exercises between sessions. Receives: Behavioral: Youth Mindful Awareness Program (YMAP) |
| Control | No intervention | Participants in this arm are randomly assigned to an assessment-only, no intervention control condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start15 May 2021
- Primary completion30 Jun 2023
- Study completion5 Jul 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MindfulnessStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mindfulness vs. No intervention control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, University of California, Los Angeles, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Judith Garber, Vanderbilt University
- Investigators
- Judy Garber, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718129
- Sponsor's protocol ID
- 570035
- Other IDs
- R61MH119270, R33MH119270
- Acronym
- YMAP
- Status last verified
- Mar 2025
- First submitted
- 29 Nov 2020
- Last updated
- 1 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be shared through Clinical Trials.gov, and by the study PIs at scientific conferences and publications in scientific journals. IPD will be available upon request.
Publications
Garber J, Chavira DA, Adam EK, Craske MG, McMahon T, Williams A, Abitante G, Lanser I, Pashtunyar DS, Chen S, Zinbarg R. A randomized controlled trial of an online mindfulness program for adolescents at risk for internalizing problems. J Consult Clin Psychol. 2025 Apr;93(4):226-237. doi: 10.1037/ccp0000921. Epub 2024 Dec 2.
PubMed 39621373
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Negative Affect Through Mindfulness Training in Youth at Risk for Internalizing Problems - R61
- ClinicalTrials.gov ID
- NCT04718129
- Acronym / sponsor ID
- YMAP / 570035
- Conditions
- Mindfulness
- Keywords
- Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Northwestern University, University of California, Los Angeles, National Institute of Mental Health (NIMH)
- Study start
- 15 May 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Posted 1 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Mindfulness vs. No intervention control
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Youth Mindful Awareness Program (YMAP)Internet-based, coached Mindfulness Program. Nine weekly coached sessions with practice exercises between sessions. |
| Control | No intervention | –Participants in this arm are randomly assigned to an assessment-only, no intervention control condition. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| 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. | Behavioural | Mindfulness |
Primary outcome
Momentary Negative Affect Assessed With Ecological Momentary Assessment
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39621373Garber J, Chavira DA, Adam EK, Craske MG, McMahon T, Williams A, Abitante G, Lanser I, Pashtunyar DS, Chen S, Zinbarg R. A randomized controlled trial of an online mindfulness program for adolescents at risk for internalizing problems. J Consult Clin Psychol. 2025 Apr;93(4):226-237. doi: 10.1037/ccp0000921. Epub 2024 Dec 2.
- Individual participant dataSharing planned: Yes. Results will be shared through Clinical Trials.gov, and by the study PIs at scientific conferences and publications in scientific journals. IPD will be available upon request.
Related trials for Mindfulness
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App-Based Mindfulness Intervention for the Improvement of Quality of Life in Patients With Metastatic Renal Cell Cancer
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The Mindful Smartphone Use Study
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Meditation for Older Adults With Chronic Low Back Pain
Chronic Low Back Pain
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The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
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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.
Judy Garber, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Youth Mindful Awareness Program (YMAP) in people with Mindfulness, run by Vanderbilt University 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 2 inclusion and 5 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 1 Apr 2025. 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 1 Apr 2025). 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?
Momentary Negative Affect Assessed With Ecological Momentary Assessment (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04718129, which also lists 1 linked publication.
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 1 Apr 2025.