360 Participants Needed

Mindfulness Program for Reducing Negative Affect in Youth

(YMAP2 Trial)

Recruiting at 2 trial locations
SD
JA
Overseen ByJudith A Garber, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Youth Mindful Awareness Program (YMAP2) for reducing negative affect in youth?

Research shows that mindfulness programs in schools can help improve emotional areas like anxiety and wellbeing in children and adolescents. Additionally, mindfulness-based interventions have been shown to reduce negative emotional reactions and improve mental health indicators in adolescents, suggesting potential benefits for treatments like YMAP2.12345

Is the Mindfulness Program for Reducing Negative Affect in Youth safe for participants?

Research on mindfulness programs for youth, including those at risk, suggests they are generally safe and can improve mental, behavioral, and physical outcomes. These programs have been implemented in schools and have shown promise in reducing stress and trauma-related symptoms without significant safety concerns.16789

How is the Youth Mindful Awareness Program (YMAP2) treatment different from other treatments for reducing negative affect in youth?

The Youth Mindful Awareness Program (YMAP2) is unique because it focuses on mindfulness, which involves being present and accepting one's thoughts and feelings, to help young people manage stress and negative emotions. Unlike traditional therapies, YMAP2 emphasizes meditation and mindfulness exercises to improve emotional regulation and reduce symptoms of anxiety and depression.25101112

What is the purpose of this trial?

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.

Research Team

MM

Megan M Saylor, PhD

Principal Investigator

Vanderbilt University

Eligibility Criteria

This trial is for at-risk youth aged 12 to 17 who often feel negative emotions like sadness or anxiety. They'll be randomly placed into one of three groups: an online mindfulness program, a supportive comparison condition, or no intervention.

Inclusion Criteria

Parental Consent
Participant Assent
Live in Illinois, California, or Tennessee
See 1 more

Exclusion Criteria

I am currently diagnosed with anxiety or depression that significantly affects my daily life.
Current alcohol or substance use disorder
Current serious suicidal ideation or behavior
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an online, coached mindfulness program or a supportive active comparison intervention for nine 30-minute weekly sessions

9 weeks
9 visits (virtual)

Follow-up

Participants are monitored for changes in momentary negative affect and internalizing symptoms

6 months
1 visit (virtual)

Treatment Details

Interventions

  • Youth Mindful Awareness Program
Trial Overview The study tests if the Youth Mindful Awareness Program can reduce feelings of negativity and anxiety in adolescents compared to other support methods or no treatment. Participants will be checked before and after the nine sessions, and again six months later.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness ProgramExperimental Treatment1 Intervention
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).
Group II: ControlActive Control1 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.
Group III: Supportive Active ComparisonActive Control1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University

Lead Sponsor

Trials
714
Recruited
6,143,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Findings from Research

The Learning 2 Breath Mindfulness Curriculum was feasible for at-risk sixth-grade female students, with a high attendance rate of 95.7% over six weeks.
While the mindfulness intervention did not show significant changes in coping skills, it did lead to a notable increase in positive affect, suggesting potential benefits for emotional well-being among at-risk youth.
Mindfulness based intervention with an attentional comparison group in at risk young adolescents: a pilot randomized controlled trial.Rawlett, KE., Friedmann, E., Thomas, SA.[2023]
Mindfulness programs in schools can lead to small improvements in cognitive skills like executive functions and emotional well-being, helping children and adolescents manage stress and anxiety more effectively.
The review highlights specific mindfulness programs, such as Paws b and Mind Up, that have been evaluated for their effectiveness, indicating a growing interest in integrating mindfulness into educational settings.
[School-based Mindfulness Programs for Children and Adolescents].Engel, N., Schiemann, S., von Salisch, M.[2020]
The Mindful Attention Awareness Scale-Adolescent (MAAS-A) was validated in a study of 595 healthy adolescents, demonstrating strong reliability and validity for measuring mindfulness in this age group.
In a separate study with 102 psychiatric adolescents, those who participated in a mindfulness-based stress reduction program showed significant increases in MAAS-A scores, which were linked to improvements in various mental health indicators, highlighting the efficacy of mindfulness interventions.
Assessing adolescent mindfulness: validation of an adapted Mindful Attention Awareness Scale in adolescent normative and psychiatric populations.Brown, KW., West, AM., Loverich, TM., et al.[2015]

References

Mindfulness based intervention with an attentional comparison group in at risk young adolescents: a pilot randomized controlled trial. [2023]
[School-based Mindfulness Programs for Children and Adolescents]. [2020]
Assessing adolescent mindfulness: validation of an adapted Mindful Attention Awareness Scale in adolescent normative and psychiatric populations. [2015]
[Mindfulness in Trainee Psychotherapies with Children and Adolescents]. [2020]
Improving self-regulation in adolescents: current evidence for the role of mindfulness-based cognitive therapy. [2020]
6.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Mindfulness Based Programs Implemented with At-Risk Adolescents. [2022]
School-Based Mindfulness Instruction: An RCT. [2022]
MINDFULNESS GOES TO SCHOOL: THINGS LEARNED (SO FAR) FROM RESEARCH AND REAL-WORLD EXPERIENCES. [2019]
The Role of Mindfulness in Reducing the Adverse Effects of Childhood Stress and Trauma. [2022]
Acceptance and commitment therapy universal prevention program for adolescents: a feasibility study. [2020]
[Mindfulness in Development-oriented Approaches to Substance Use Prevention and Therapy: Rationale, Design and Objectives of the Research Consortium IMAC-Mind]. [2020]
Do mindfulness-based programmes improve the cognitive skills, behaviour and mental health of children and adolescents? An updated meta-analysis of randomised controlled trials. [2023]
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