Mindfulness and Life Skills Programs for Behavioral Issues

Overseen By Nicole Morrell

Age: < 18

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Minnesota

Disqualifiers: Special education, Autism, Intellectual disability, Serious psychiatric, others

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

Compensation: Varies

Number of Visits: 3

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to prevent serious behavior issues in adolescents by testing three different programs: a mindfulness program called Learning to Breathe (L2B), an enhanced version of L2B with a mobile app, and a life skills program called Skills for Success. The goal is to determine if these programs can assist high school students at risk of conduct problems. Eligible participants include 9th or 10th graders at risk of behavior issues, referred by school staff or identified through screening. As a Phase 1 and Phase 2 trial, this research aims to understand how these programs function in individuals and measure their effectiveness in an initial, smaller group, offering participants a chance to contribute to innovative solutions for behavior issues.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Learning to Breathe (L2B) mindfulness program is generally well-received by participants. Studies have found that it helps high school students reduce stress and manage their emotions better, without causing significant side effects. For the L2B program with the app, research supports its effectiveness in helping students use mindfulness techniques in their daily lives, also without significant negative effects.

The Skills for Success program teaches basic skills for personal and professional growth. Available information does not report any safety issues or negative events for participants.

Since this trial is in the early stages (Phase 1 and Phase 2), it mainly focuses on checking the safety and how well participants handle the programs. This means the treatments are still being tested, and safety information is still being gathered. However, based on current evidence, these programs seem to be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these mindfulness and life skills programs because they offer innovative approaches to tackling behavioral issues. Unlike traditional therapies that might focus solely on counseling or medication, the Learning to Breathe (L2B) treatment emphasizes mindfulness techniques that help individuals manage stress and emotions. The L2B + App variant adds a digital component, making mindfulness practices more accessible and adaptable to everyday life. Meanwhile, the Skills for Success program focuses on building practical life skills, aiming to improve overall well-being and resilience. These approaches provide a holistic alternative to conventional methods, potentially leading to more sustainable and impactful outcomes.

What evidence suggests that this trial's treatments could be effective for reducing adolescent conduct problems?

Research has shown that the Learning to BREATHE (L2B) program, to which participants in this trial may be randomized, helps students develop important social and emotional skills and manage their emotions more effectively. Studies have found that it reduces stress and physical symptoms caused by stress. Another arm of this trial will test the addition of a mobile app to L2B, which appears to enhance these benefits, leading to improved focus and mental health. The Skills for Success program, also tested in this trial, has reduced aggressive behavior and improved emotional control. Overall, these programs show promise in addressing behavioral issues in teenagers. ^{1 2 6 7 8}

Who Is on the Research Team?

Timothy Piehler

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for 9th or 10th grade students in a partner school district who are at risk for conduct problems, as indicated by a screening tool or referral from school staff. Participants and their parents must be fluent in English.

Inclusion Criteria

I was referred for help because of high emotional/social risk or school behavior issues.

My parents and I are fluent in English.

I am a 9th or 10th grader in a partner school.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomly assigned to one of three intervention options: a mindfulness-based program, a mindfulness-based program with a mobile app, or a life skills program

15 weeks

Assessments at baseline and 2 weeks post-intervention

Follow-up

Participants are monitored for intervention outcomes at a 3-month follow-up

3 months

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• L2B
• L2B + App
• skills for success

Trial Overview The study compares three interventions to reduce adolescent conduct problems: a mindfulness-based program (L2B), the same program with an additional mobile app (L2B + App), and a life skills program (skills for success). It's randomized, meaning participants are placed into groups by chance.

How Is the Trial Designed?

Group I: The Learning to breathe (L2B) Experimental Treatment 1 Intervention

randomized to the Learning to Breathe (L2B) mindfulness intervention

Group II: Skills for Success Experimental Treatment 1 Intervention

randomized to Skills for Success

Group III: L2B+App Experimental Treatment 1 Intervention

randomized to the Learning to Breathe plus App condition

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

In a study involving 1,687 substance-abusing participants over 27,198 person-weeks, 12% experienced serious adverse events (SAEs), but none were deemed related to the psychosocial interventions being tested.

There were no significant differences in the incidence rates of SAEs between those receiving standard care and those receiving additional interventions like contingency management or motivational enhancement, suggesting that these psychosocial treatments are safe in terms of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? Petry, NM., Roll, JM., Rounsaville, BJ., et al.[2021]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

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]

The REACH II program, a multi-site trial focused on caregivers of Alzheimer's patients, highlighted the need for tailored safety monitoring and adverse event reporting protocols in psychosocial and behavioral intervention studies, as existing guidelines primarily address medical interventions.

The study identified unique challenges in defining and classifying adverse events, as well as establishing resolution criteria, emphasizing the variability in safety monitoring practices across psychosocial trials and the necessity for standardized protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data and safety monitoring in social behavioral intervention trials: the REACH II experience. Czaja, SJ., Schulz, R., Belle, SH., et al.[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]

A mindfulness-based intervention combined with standard outpatient treatment significantly reduced symptoms of depression, anxiety, and anger expression in participants over three months, with 22 individuals in the experimental group and 20 in the control group.

Despite improvements in mental health symptoms, the intervention did not show a significant effect on substance use behavior, indicating the need for further research to explore its overall impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The contribution of mindfulness to outpatient substance use disorder treatment in Brazil: a preliminary study. Machado, MP., Fidalgo, TM., Brasiliano, S., et al.[2021]

An 8-week follow-on mindfulness course focusing on awareness of feeling tone was effective in reducing depression, stress, and anxiety among 83 participants, with significant improvements in well-being and mindfulness.

While most participants experienced some unpleasant feelings during the course, none reported harm, indicating that the program is safe, even for those with prior mindfulness experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Next After MBSR/MBCT? An Open Trial of an 8-Week Follow-on Program Exploring Mindfulness of Feeling Tone (vedan&#257;). Williams, JMG., Baer, R., Batchelor, M., 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]

Citations

1. learning2breathe.org learning2breathe.org/research-2/

L2B Research These findings provide promising evidence of the effectiveness of Learning to BREATHE on the development of key social-emotional learning skills. The ...

2. researchgate.net researchgate.net/publication/242329939_The_Effectiveness_of_the_Learning_to_BREATHE_Program_on_Adolescent_Emotion_Regulation

The Effectiveness of the Learning to BREATHE Program on ... These findings provide promising evidence of the effectiveness of Learning to Breathe on the development of key social-emotional learning skills ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7705247/

Learning to BREATHE “Plus”: A Multi-Modal Adaptive ... There is growing evidence to support the effectiveness of Learning to BREATHE (L2B) (6), an MBI that is rooted in the philosophy of mindfulness ...

4. scholarsarchive.library.albany.edu scholarsarchive.library.albany.edu/cgi/viewcontent.cgi?article=1218&context=etd

Investigating a Brief Mindfulness Curriculum on On-Task ... The current study aimed to evaluate the effectiveness of L2B as a standalone intervention as well as the additional effect of integrating CI/CO.

5. tandfonline.com tandfonline.com/doi/abs/10.1080/15427609.2013.818488

The Effectiveness of the Learning to BREATHE Program on ... Program participants reported statistically lower levels of perceived stress and psychosomatic complaints and higher levels of efficacy in affective regulation.

6. researchgate.net researchgate.net/publication/264499592_Learning_to_BREATHE_An_intervention_to_foster_mindfulness_in_adolescence

An intervention to foster mindfulness in adolescence Learning to BREATHE (L2B) is a mindfulness-based universal prevention program for adolescents that was designed to be integrated into ...

7. learning2breathe.org learning2breathe.org/research-summary-table/

Research Summary Table Learning to BREATHE (L2B) is a sequenced mindfulness program that can be used to introduce adolescents to mindfulness and its practice.

8. health.extension.wisc.edu health.extension.wisc.edu/learning-to-breathe/

Learning to BREATHE - Health & Well-Being Learning to BREATHE (L2B) is a research-based mindfulness curriculum designed for youth audiences. The goal of the program is to improve emotion regulation.