PreventionYMAP2NCT06526052
A Randomized Controlled Trial Testing the Effect of the Youth Mindful Awareness Program on Negative Affect (YMAP2).
A study testing Mindfulness Program and Active Comparator in people with Prevention and Control, run by Vanderbilt University at 3 sites in United States.
Trial summary
The goal of this randomized clinical trial is to compare the effects of an online mindfulness program to an active supportive comparison condition and a no-intervention control group on reducing and preventing mood and anxiety symptoms in at-risk youth. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention, Control
- What is being tested?
- Mindfulness Program and Active Comparator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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, 13, 14, 15, 16, 17
- Parental Consent
- Participant Assent
- Live in Illinois, California, or Tennessee
Who cannot join
- current diagnosis of an anxiety or depressive disorder with significant clinical impairment
- current alcohol or substance use disorder
- current serious suicidal ideation or behavior
- 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
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Northwestern University
Evanston, Illinois, 60208
Richard E Zinbarg, PhD, 847-467-2290, rzinbarg@northwestern.edu
Emma K Adam, PhD, 847-467-2010, ek-adam@northwestern.edu
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Michelle G Craske, PhD, 310-825-8403, MCraske@mednet.ucla.edu
Denise A Chavira, PhD, 310-825-8466, dchavira@psych.ucla.edu
- Recruiting
Vanderbilt University
Nashville, Tennessee, 37203-5721
Judith A Garber, PhD, 615-330-5605, jgarber.vanderbilt@gmail.com
Steven D Hollon, PhD, 6153305604, steven.d.hollon@vanderbilt.edu
About this study
Official title: Targeting Negative Affect Through Mindfulness Training in Youth at Risk for Internalizing Problems (R33)
The goal of this randomized clinical trial is to compare the effects of an online mindfulness program to an active supportive comparison condition and a no-intervention control group on reducing and preventing mood and anxiety symptoms in at-risk youth. Youth who are high on trait negative affect will be randomized to one of the three conditions. The primary outcomes of interest are reductions in momentary negative affect and internalizing problems in adolescents ages 12 to 17 years old. All participants will be evaluated prior to being randomized, after the 9-session intervention period, and at a 6-month follow-up.
The first hypothesis is that the mindfulness intervention will predict decreases in stressor-reactive momentary negative affect and internalizing symptoms. The second hypothesis is that changes in momentary negative affect will partially account for the effects of the mindfulness intervention on internalizing symptoms.
Read the detailed description
Rates of anxiety and depression in youth are substantial, causing a major unmet need for effective prevention and treatment. A salient risk factor for anxiety and depression is negative affectivity - a partially heritable propensity to experience and express more frequent, intense, and enduring aversive emotional states. Prior longitudinal studies have shown that elevated trait negative affectivity (tNA) during mid-adolescence predicted internalizing disorders later in adolescence and early adulthood, and this relation was partially mediated by changes in momentary negative affect (mNA) measured with ecological momentary assessment (EMA). The conceptual rationale for this investigation is as follows: Trait negative affectivity (tNA) is a risk factor for internalizing symptoms and disorders. tNA also predicts higher levels of momentary negative affect (mNA), measured with EMA, which in turn partially accounts for the prospective association between tNA and symptoms of anxiety and depression. Mindfulness interventions reduce both mNA and internalizing symptoms. Given these empirical relations, this study will test whether in youth with high levels of tNA, an online, coached mindfulness program reduces mNA, as measured with EMA, and whether significantly reducing mNA via a mindfulness intervention then prevents the worsening or onset of internalizing problems.
Mindfulness-based interventions have been found to reduce negative affect and internalizing symptoms in children and adolescents. This study will evaluate changes in mNA as a transdiagnostic target of mindfulness-based training in youth at high risk (i.e., high tNA) for internalizing problems, and the degree to which reductions in such mNA partially account for the effects of mindfulness training on internalizing outcomes in youth. This randomized controlled prevention trial will test the extent to which youth assigned to an online, coached mindfulness program as compared to youth in a supportive attention comparison intervention and a no-intervention control condition will show reduced mNA and its two components -- stressor-independent and stressor-reactive momentary negative affect. The mindfulness training will be implemented through mobile technology (e.g., online program). Investigating the efficacy of an online mode of delivery of mindfulness with support of a coach can advance the prevention of internalizing psychopathology in a manner that could be disseminated broadly. Such technology would improve access to care for youth who can be easily identified as being vulnerable to internalizing problems due to having high levels of tNA.
- Conditions
- Prevention, Control
- Being tested
- Mindfulness Program, Active Comparator
- Keywords
- Adolescents, Mindfulness, Internalizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness ProgramBehavioural
Online, coached mindfulness training program
Active ComparatorBehavioural
Also called Supportive Active Comparison
Remote meetings with a supportive coach
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Program | Experimental | The Mindfulness Program is an online, coached intervention that teaches mindfulness activities such as calm breathing, listening, acceptance, gratitude, and compassion. Participants meet with their coach weekly for nine 30-minute, weekly sessions in which they learn mindfulness skills and practice using the mindfulness exercises between sessions. Meetings are done remotely (e.g., Zoom). Receives: Behavioral: Mindfulness Program |
| Supportive Active Comparison | Active comparator | The Supportive Active condition involves participants meeting remotely (e.g., Zoom) with a coach for nine 30-minute, weekly sessions during which teens discuss their thoughts and feelings about things going on in their life. Coaches are instructed to use active listening, open-ended questions, empathy, reflection, and unconditional positive regard. Between sessions, teens use expressive writing to describe and understand their thoughts and feelings about situations in their life. Receives: Behavioral: Active Comparator |
| Control | No intervention | This is an assessment only control condition. Participants complete all of the same measures as do youth in the other two conditions at the same time points (i.e., baseline, post-intervention (about 10 weeks after baseline) and at a six-month follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ecological Momentary Assessment of Momentary Negative Affect and Stress
EMA involves assessments four times a day for 7 days. The measures of momentray negative affect (mNA) from the EMA are Stressor-Independent (mNA-SI), Stressor-Reactive (mNA-SR), and average mNA.
Measured: week 10
Internalizing symptoms factor
The internalizing symptoms factor is based on a principal components analyses (PCAs) of the change scores for child symptom scales including the Negative Affectivity (NA-15), the Patient Health Question 9 (PHQ9 - measure of depressive symptoms), Generalized Anxiety Disorder 7 (GAD7 - measure of symptoms of anxiety), and the Screen for Child Anxiety Related Disorders (SCARED).
Measured: week 12
Secondary outcomes (3)
Internalizing symptoms factor
The internalizing symptoms factor is based on a principal components analyses (PCAs) of the change scores for child symptom scales including the Negative Affectivity (NA-15), the Patient Health Question 9 (PHQ9 - measure of depressive symptoms), Generalized Anxiety Disorder 7 (GAD7 - measure of symptoms of anxiety), and the Screen for Child Anxiety Related Disorders (SCARED).
Measured: Six-months
Diagnoses of Anxiety and Depressive Disorders
The Schedule for Affective Disorders and Schizophrenia for School-Age Children - Present and Lifetime Version assesses diagnoses at and since baseline and screens for exclusion criteria at baseline (Kaufman et al., 1997).
Measured: week 12
Diagnoses of Anxiety and Depressive Disorders
The Schedule for Affective Disorders and Schizophrenia for School-Age Children - Present and Lifetime Version (KSADs-PL) assesses diagnoses of anxiety and depressive disorders since the post-intervention assessment.
Measured: Six-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Apr 2024
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreventionStudies 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
- Participants are randomly assigned to one of three conditions in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Judith Garber, Vanderbilt University
- Investigators
- Megan M Saylor, PhD, Study chair, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526052
- Sponsor's protocol ID
- R33MH119270
- Other IDs
- 4R33MH119270-03
- Acronym
- YMAP2
- Status last verified
- Aug 2025
- First submitted
- 17 Jul 2024
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 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 (R33)
- ClinicalTrials.gov ID
- NCT06526052
- Acronym / sponsor ID
- YMAP2 / R33MH119270
- Conditions
- Prevention, Control
- Keywords
- Adolescents, Mindfulness, Internalizing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized clinical trial is to compare the effects of an online mindfulness program to an active supportive comparison condition and a no-intervention control group on reducing and preventing mood and anxiety symptoms in at-risk youth. Youth who are high on trait negative affect will be randomized to one of the three conditions. The primary outcomes of interest are reductions in momentary negative affect and internalizing problems in adolescents ages 12 to 17 years old. All participants will be evaluated prior to being randomized, after the 9-session intervention period, and at a 6-month follow-up.
The first hypothesis is that the mindfulness intervention will predict decreases in stressor-reactive momentary negative affect and internalizing symptoms. The second hypothesis is that changes in momentary negative affect will partially account for the effects of the mindfulness intervention on internalizing symptoms.
Detailed description
Rates of anxiety and depression in youth are substantial, causing a major unmet need for effective prevention and treatment. A salient risk factor for anxiety and depression is negative affectivity - a partially heritable propensity to experience and express more frequent, intense, and enduring aversive emotional states. Prior longitudinal studies have shown that elevated trait negative affectivity (tNA) during mid-adolescence predicted internalizing disorders later in adolescence and early adulthood, and this relation was partially mediated by changes in momentary negative affect (mNA) measured with ecological momentary assessment (EMA). The conceptual rationale for this investigation is as follows: Trait negative affectivity (tNA) is a risk factor for internalizing symptoms and disorders. tNA also predicts higher levels of momentary negative affect (mNA), measured with EMA, which in turn partially accounts for the prospective association between tNA and symptoms of anxiety and depression. Mindfulness interventions reduce both mNA and internalizing symptoms. Given these empirical relations, this study will test whether in youth with high levels of tNA, an online, coached mindfulness program reduces mNA, as measured with EMA, and whether significantly reducing mNA via a mindfulness intervention then prevents the worsening or onset of internalizing problems.
Mindfulness-based interventions have been found to reduce negative affect and internalizing symptoms in children and adolescents. This study will evaluate changes in mNA as a transdiagnostic target of mindfulness-based training in youth at high risk (i.e., high tNA) for internalizing problems, and the degree to which reductions in such mNA partially account for the effects of mindfulness training on internalizing outcomes in youth. This randomized controlled prevention trial will test the extent to which youth assigned to an online, coached mindfulness program as compared to youth in a supportive attention comparison intervention and a no-intervention control condition will show reduced mNA and its two components -- stressor-independent and stressor-reactive momentary negative affect. The mindfulness training will be implemented through mobile technology (e.g., online program). Investigating the efficacy of an online mode of delivery of mindfulness with support of a coach can advance the prevention of internalizing psychopathology in a manner that could be disseminated broadly. Such technology would improve access to care for youth who can be easily identified as being vulnerable to internalizing problems due to having high levels of tNA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to one of three conditions in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Program | Experimental | Behavioral: Mindfulness ProgramThe Mindfulness Program is an online, coached intervention that teaches mindfulness activities such as calm breathing, listening, acceptance, gratitude, and compassion. Participants meet with their coach weekly for nine 30-minute, weekly sessions in which they learn mindfulness skills and practice using the mindfulness exercises between sessions. Meetings are done remotely (e.g., Zoom). |
| Supportive Active Comparison | Active comparator | Behavioral: Active ComparatorThe Supportive Active condition involves participants meeting remotely (e.g., Zoom) with a coach for nine 30-minute, weekly sessions during which teens discuss their thoughts and feelings about things going on in their life. Coaches are instructed to use active listening, open-ended questions, empathy, reflection, and unconditional positive regard. Between sessions, teens use expressive writing to describe and understand their thoughts and feelings about situations in their life. |
| Control | No intervention | –This is an assessment only control condition. Participants complete all of the same measures as do youth in the other two conditions at the same time points (i.e., baseline, post-intervention (about 10 weeks after baseline) and at a six-month follow-up. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Ages 12, 13, 14, 15, 16, 17
- Parental Consent
- Participant Assent
- Live in Illinois, California, or Tennessee
Key exclusion criteria (6 listed)
- current diagnosis of an anxiety or depressive disorder with significant clinical impairment
- current alcohol or substance use disorder
- current serious suicidal ideation or behavior
- lifetime diagnosis of bipolar disorder, schizophrenia, autism, conduct disorder, or developmental delay
- reading level below 4th grade
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 |
|---|---|---|
| Mindfulness ProgramOnline, coached mindfulness training program | Behavioural | Mindfulness Program |
| Active ComparatorAlso: Supportive Active ComparisonRemote meetings with a supportive coach | Behavioural | Supportive Active Comparison |
Primary outcome
Ecological Momentary Assessment of Momentary Negative Affect and Stress
Time frame: week 10
EMA involves assessments four times a day for 7 days. The measures of momentray negative affect (mNA) from the EMA are Stressor-Independent (mNA-SI), Stressor-Reactive (mNA-SR), and average mNA.
Internalizing symptoms factor
Time frame: week 12
The internalizing symptoms factor is based on a principal components analyses (PCAs) of the change scores for child symptom scales including the Negative Affectivity (NA-15), the Patient Health Question 9 (PHQ9 - measure of depressive symptoms), Generalized Anxiety Disorder 7 (GAD7 - measure of symptoms of anxiety), and the Screen for Child Anxiety Related Disorders (SCARED).
3 secondary outcomes
Internalizing symptoms factor
Time frame: Six-months
Diagnoses of Anxiety and Depressive Disorders
Time frame: week 12
Diagnoses of Anxiety and Depressive Disorders
Time frame: Six-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Megan M Saylor, PhD study chair
Vanderbilt University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Program and Active Comparator in people with Prevention and Control, run by Vanderbilt University at 3 sites 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judith A Garber, PhD (6153305605, jgarber.vanderbilt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ecological Momentary Assessment of Momentary Negative Affect and Stress (time frame: week 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2025.