Mindfulness Program for Reducing Negative Affect in Youth

(YMAP2 Trial)

Recruiting at 2 trial locations

Overseen By Judith A Garber, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University

Disqualifiers: Anxiety, Depression, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 9 weeks

360 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{2 5 10 11 12}

Research Team

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

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

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

Group I: Mindfulness Program Experimental Treatment 1 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: Control Active Control 1 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 Comparison Active Control 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Mindfulness-based interventions (MBIs) are increasingly being integrated into cognitive-behavioral therapy for children and adolescents, but research on their specific implementation in individual therapy is still limited.

The 'Mindfulness and Relaxation Study - Children and Adolescents' (MARS-CA) is examining the effects of mindfulness and relaxation interventions on young patients' symptoms and therapeutic relationships, with preliminary results indicating that both types of interventions are effective with juvenile patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness in Trainee Psychotherapies with Children and Adolescents]. Kalmar, J., Engel, S., Baumann, I., et al.[2020]

Mindfulness-based cognitive therapy (MBCT) is effective in helping individuals manage psychological symptoms like depression and anxiety by teaching them to regulate their attention through meditation.

Empirical studies support the use of MBCT for youth, particularly those struggling with negative thought patterns like rumination, indicating its potential as a valuable treatment option for adolescents facing emotional challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving self-regulation in adolescents: current evidence for the role of mindfulness-based cognitive therapy. Perry-Parrish, C., Copeland-Linder, N., Webb, L., et al.[2020]

The review identified only 11 studies on mindfulness programs for at-risk adolescents, highlighting a lack of extensive research in this area, which limits the ability to generalize findings for practical application.

There is a noted connection between health behaviors and academic success, suggesting that mindfulness interventions could potentially improve outcomes for at-risk youth, but more research is needed to explore these effects comprehensively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness Based Programs Implemented with At-Risk Adolescents. Rawlett, K., Scrandis, D.[2022]

A study involving 300 low-income, minority middle school students in Baltimore showed that an adapted mindfulness-based stress reduction (MBSR) program significantly reduced symptoms of depression, negative affect, and posttraumatic stress compared to a health education program.

The MBSR program effectively improved psychological functioning among students facing significant stressors, indicating its potential as a valuable intervention for vulnerable youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-Based Mindfulness Instruction: An RCT. Sibinga, EM., Webb, L., Ghazarian, SR., et al.[2022]

Many mindfulness-based programs in K-12 schools, such as Inner Explorer and Mindful Schools, lack substantial research backing their effectiveness, despite being widely implemented.

The review highlights the need for more rigorous evaluations of these programs to assess their feasibility, acceptability, and overall impact on students' well-being, encouraging collaboration among researchers and educators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MINDFULNESS GOES TO SCHOOL: THINGS LEARNED (SO FAR) FROM RESEARCH AND REAL-WORLD EXPERIENCES. Semple, RJ., Droutman, V., Reid, BA.[2019]

Mindfulness interventions have been shown to significantly improve mental, behavioral, and physical health outcomes in children and youth exposed to adverse childhood experiences, potentially reducing long-term health risks.

Structured mindfulness instruction may help mitigate the negative effects of stress and trauma from childhood, suggesting a promising approach for improving both immediate and future well-being in affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Mindfulness in Reducing the Adverse Effects of Childhood Stress and Trauma. Ortiz, R., Sibinga, EM.[2022]

The study explored the feasibility of an Acceptance and Commitment Therapy (ACT)-based prevention program for anxiety and depression among 48 high school students, showing that the program was acceptable and could be effectively implemented in a school setting.

While no statistically significant differences were found between the ACT intervention and usual classes, the effect sizes indicated potential benefits of the ACT program, suggesting it could be a promising approach for preventing anxiety and depression in young people and warrants further research with a larger sample.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy universal prevention program for adolescents: a feasibility study. Burckhardt, R., Manicavasagar, V., Batterham, PJ., et al.[2020]

Mindfulness-based interventions may effectively reduce risk factors for substance use disorders (SUD) in children and adolescents, addressing issues like reward sensitivity and impulsivity that contribute to addiction.

The ongoing research consortium IMAC-Mind aims to integrate mindfulness exercises into existing prevention and treatment programs, highlighting the potential for these approaches to improve mental health and reduce addiction in young populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness in Development-oriented Approaches to Substance Use Prevention and Therapy: Rationale, Design and Objectives of the Research Consortium IMAC-Mind]. Arnaud, N., Banaschewski, T., Nees, F., et al.[2020]

Mindfulness-based programs (MBPs) have shown effectiveness in improving anxiety, attention, and social behavior in young people, with a meta-analysis of 66 randomized controlled trials involving over 20,000 participants indicating moderate effect sizes compared to passive controls.

However, the overall quality of evidence is low and inconclusive, especially regarding long-term benefits, as studies with follow-up did not show significant positive effects, suggesting that more rigorous research is needed to fully understand the potential of MBPs for youth mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do mindfulness-based programmes improve the cognitive skills, behaviour and mental health of children and adolescents? An updated meta-analysis of randomised controlled trials. Dunning, D., Tudor, K., Radley, L., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Mindfulness based intervention with an attentional comparison group in at risk young adolescents: a pilot randomized controlled trial. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

[School-based Mindfulness Programs for Children and Adolescents]. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Assessing adolescent mindfulness: validation of an adapted Mindful Attention Awareness Scale in adolescent normative and psychiatric populations. [2015]

4. Germany pubmed.ncbi.nlm.nih.gov

[Mindfulness in Trainee Psychotherapies with Children and Adolescents]. [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Improving self-regulation in adolescents: current evidence for the role of mindfulness-based cognitive therapy. [2020]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Mindfulness Based Programs Implemented with At-Risk Adolescents. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

School-Based Mindfulness Instruction: An RCT. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

MINDFULNESS GOES TO SCHOOL: THINGS LEARNED (SO FAR) FROM RESEARCH AND REAL-WORLD EXPERIENCES. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of Mindfulness in Reducing the Adverse Effects of Childhood Stress and Trauma. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy universal prevention program for adolescents: a feasibility study. [2020]

11. Germany pubmed.ncbi.nlm.nih.gov

[Mindfulness in Development-oriented Approaches to Substance Use Prevention and Therapy: Rationale, Design and Objectives of the Research Consortium IMAC-Mind]. [2020]

12. England pubmed.ncbi.nlm.nih.gov

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]