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

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 L2B, L2B + App, skills for success in the clinical trial Mindfulness and Life Skills Programs for Behavioral Issues?

Mindfulness-based programs have been shown to be effective in many studies, including for substance use disorders and personality disorders, by improving symptoms like depression, anxiety, and anger. Additionally, mindfulness delivered through smartphone applications has been evaluated for its effectiveness, suggesting potential benefits for similar app-based treatments. ^{1 2 3 4 5}

Is the Mindfulness and Life Skills Program safe for participants?

Research on similar psychosocial and behavioral programs shows that serious adverse events (unexpected negative effects) are rare and not typically related to the study itself. Safety monitoring is important, but these types of programs are generally considered safe for participants. ^{6 7 8 9 10}

How is the treatment 'Mindfulness and Life Skills Programs for Behavioral Issues' different from other treatments?

This treatment is unique because it combines mindfulness (a practice of being present and aware) with life skills training, which can help manage emotions and behaviors. Unlike traditional treatments that may focus solely on medication or therapy, this approach integrates mindfulness to potentially reduce anxiety and depression, as seen in similar programs for adolescents. ^{11 12 13 14 15}

What is the purpose of this trial?

This study involves a 3-arm randomized controlled trial designed to investigate the feasibility and acceptability of three preventive interventions designed to reduce risk for escalations in adolescent conduct problems. High school students identified to be at risk for conduct problems will be randomly assigned to one of three intervention options, including a mindfulness-based program, a mindfulness-based program augmented by a new mobile app, and a life skills program. Assessments related to intervention outcomes will be completed by adolescents, parents/guardians, and teachers at baseline, 2 weeks post-intervention, and at a 3-month follow-up.

Research Team

Timothy Piehler

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

The contribution of mindfulness to outpatient substance use disorder treatment in Brazil: a preliminary study. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Which are the best questionnaires to longitudinally evaluate mindfulness skills in personality disorders? [2021]

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

Reporting of Treatment Fidelity in Mindfulness-Based Intervention Trials: A Review and New Tool using NIH Behavior Change Consortium Guidelines. [2020]

4. United States 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;). [2022]

5. England pubmed.ncbi.nlm.nih.gov

Behavioural activation versus mindfulness-based guided self-help treatment administered through a smartphone application: a randomised controlled trial. [2022]

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

Personal and social skills training: cognitive-behavioral approaches to substance abuse prevention. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Data and safety monitoring in social behavioral intervention trials: the REACH II experience. [2022]

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

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? [2021]

9. England pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Is more better? Outcome and dose of a universal drug prevention effectiveness trial. [2022]

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

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

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

When you see it, let it be: Urgency, mindfulness and adolescent substance use. [2022]

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

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

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

Implementation Science of Mindfulness in Intellectual and Developmental Disabilities. [2021]

15. England pubmed.ncbi.nlm.nih.gov

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