Leadership Program for Mental Health Wellness

(FLP Trial)

Recruiting at 1 trial location

Overseen By Mario Cruz-Gonzalez, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Disqualifiers: Pilot phase, Attendance, Grades, Language

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

Compensation: Varies

Number of Visits: 16

504 Participants Needed

Trial Summary

What is the purpose of this trial?

The current study tests the feasibility and effectiveness of a youth intervention designed to provide meaningful leadership opportunities and to address barriers to equity, through the acquisition of civic leadership and development skills as well as mindfulness practice, LEAP: Leadership, Engagement, and youth Activism Program with Mindfulness. The goal of this project is to determine whether the Leadership, Engagement, and youth Activism Program with Mindfulness (LEAP) curriculum, which was developed with youth of color, is a feasible and effective intervention for fostering civic leadership, civic development, and wellbeing. The investigators seek to understand whether LEAP can support wellbeing for youth of color as a strategy to increase youth mental, emotional, and behavioral (MEB) health and decrease health disparities in youth of color.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on leadership and mindfulness rather than medication use.

What data supports the effectiveness of the treatment EnvisionIT, Leadership, Engagement, and youth Activism Program with Mindfulness?

Research shows that mindfulness meditation can significantly reduce anxiety in adolescents, and mindfulness-based group therapy has been linked to improved mood and reduced heart rate in psychiatrically hospitalized adolescents. These findings suggest that incorporating mindfulness into the treatment could help improve mental health wellness in youth. ^{1 2 3 4 5}

Is the Leadership Program for Mental Health Wellness safe for humans?

The available research on mindfulness-based programs, which are part of the Leadership Program for Mental Health Wellness, suggests that while benefits are well-documented, the potential for harm has not been comprehensively studied. However, mindfulness practices have been implemented in various settings, such as schools and psychiatric units, with reports of positive outcomes like reduced anxiety and increased calmness, indicating a general perception of safety. ^{2 6 7 8 9}

How is the Leadership, Engagement, and Youth Activism Program with Mindfulness treatment different from other mental health treatments?

This treatment is unique because it combines leadership and activism with mindfulness practices, specifically targeting youth in a school setting to enhance mental health and engagement. Unlike traditional treatments that may focus solely on therapy or medication, this program integrates personal development and community involvement to promote mental wellness. ^{10 11 12 13 14}

Research Team

Mario Cruz-Gonzalez, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for young people who are dealing with problem behaviors, teenage rebellion, and mental health challenges. It's specifically designed to support youth of color in fostering their wellbeing and leadership skills.

Inclusion Criteria

I am 14 or older and in grades 9-12 in Fall/Winter or 9-11 in Spring.

Enrolled in a partner site in MA or Chicago, IL

If I am under 18, my parents and I agree to my participation. If 18 or older, I consent myself.

Exclusion Criteria

They participated in the pilot phase (UG3)

They cannot commit to participation in the full study (e.g., attendance at all intervention sessions)

I am not a high school student in grades 9-12 at a partner site.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the LEAP or EnvisionIT program, consisting of 14 two-hour sessions focused on leadership, mindfulness, and career readiness.

14 weeks

14 sessions (in-person)

Follow-up

Participants are monitored for program outcomes and wellbeing at multiple time points post-intervention.

9 months

Assessments at baseline, 2-3 months, 6 months, and 9 months

Treatment Details

Interventions

• EnvisionIT
• Leadership, Engagement, and youth Activism Program with Mindfulness

Trial Overview The study is testing the LEAP program which includes leadership training, civic engagement activities, and mindfulness practices. The aim is to see if this can improve mental, emotional, and behavioral health among youth of color.

Participant Groups

Group I: Leadership, Engagement, and youth Activism Program with Mindfulness Experimental Treatment 1 Intervention

The Leadership, Engagement, and youth Activism Program with Mindfulness intervention (LEAP) consists of 14 sessions focused on youth civic engagement, leadership, and mindfulness.

Group II: EnvisionIT Active Control 1 Intervention

EnvisionIT is a college and career-readiness program designed for students in grades 6-12. The EnvisionIT program will be delivered over 14 sessions, and focus on skills and career/college readiness.

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Recruited

14,100+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

Mindfulness-based interventions significantly reduce various symptoms of schizophrenia, including psychotic, positive, and negative symptoms, as well as depressive symptoms and rehospitalization duration, based on a meta-analysis of nine randomized controlled trials.

The positive effects on negative symptoms can last for at least 3 to 6 months, and nurse-led mindfulness interventions were found to be more effective in reducing positive symptoms compared to those led by psychologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness-based intervention on psychotic symptoms for patients with schizophrenia: A meta-analysis of randomized controlled trials. Liu, YC., Li, IL., Hsiao, FH.[2021]

Mindfulness meditation (MM) groups led by chaplains significantly reduced state-anxiety in 53 adolescent inpatients aged 13-19, indicating its potential as an effective intervention for anxiety in this high-risk population.

The study suggests that adolescents with psychotic symptoms may experience even greater benefits from MM, highlighting the need for further research and implementation of such programs in psychiatric care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness Meditation and Anxiety in Adolescents on an Inpatient Psychiatric Unit. Blum, H., Rutt, C., Nash, C., et al.[2021]

Mindfulness training led to significant improvements in psychological symptoms and quality of life for a diverse group of 143 psychiatric outpatients, indicating its overall efficacy as a therapeutic intervention.

However, patients with bipolar disorder did not show significant improvement, which may be linked to their longer illness duration and lower baseline severity compared to other diagnostic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness training in a heterogeneous psychiatric sample: outcome evaluation and comparison of different diagnostic groups. Bos, EH., Merea, R., van den Brink, E., et al.[2019]

The iMatter program, which teaches mindfulness and relaxation strategies to adolescents in a psychiatric hospital, showed positive effects, with participants reporting improved mood after sessions.

Physiological measures indicated that participants experienced a significant decrease in heart rate following mindfulness group sessions, suggesting a calming effect of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based group therapy: Impact on psychiatrically hospitalized adolescents. Sams, DP., Handley, ED., Alpert-Gillis, LJ.[2019]

A 5-week mindfulness-based group intervention significantly reduced mental distress in adolescents with mixed mental health disorders, showing a moderate effect size (Cohen's d = 0.43) immediately after the intervention and a larger effect (Cohen's d = 0.78) at a 3-month follow-up.

The mindfulness training not only improved mental health outcomes but also enhanced self-esteem and psychological flexibility, indicating that mindfulness can be an effective adjunctive therapy for adolescents receiving standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taming the adolescent mind: a randomised controlled trial examining clinical efficacy of an adolescent mindfulness-based group programme. Tan, L., Martin, G.[2020]

A 6-week mindfulness program led by teachers in a low-income school showed positive perceptions from teachers, who noted that students became calmer and more relaxed, indicating potential benefits for emotional regulation.

The program's success suggests that training teachers to incorporate mindfulness into their classrooms is feasible and could be a valuable strategy for addressing the impacts of adverse childhood experiences (ACEs) in disadvantaged communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a teacher-led mindfulness program in a low-income pre- and early-elementary school as part of a trauma-responsive, resilience-building community initiative. King, LM., Lewis, C., Ritchie, DM., et al.[2021]

School administrators adopted the RAP Club, a trauma-informed mindfulness intervention, primarily to support students affected by trauma and to prevent unhealthy coping behaviors, highlighting the importance of addressing student mental health needs.

Factors influencing the adoption included the absence of existing trauma-informed programs, insufficient funding for mental health services, and the perceived advantages of collaborating with a university, suggesting that these contextual elements are crucial for implementing similar interventions in schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors that Influenced Adoption of a School-Based Trauma-Informed Universal Mental Health Intervention. Arnold, KT., Pollack Porter, KM., Frattaroli, S., et al.[2021]

While mindfulness-based programs (MBPs) are known for their benefits, the potential for harm has not been thoroughly investigated, indicating a need for more research in this area.

The study identifies three key factors that may contribute to harm in MBPs: program-related factors, participant-related factors, and clinician-related factors, suggesting that understanding these can help improve safety and effectiveness in future mindfulness practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doing no harm in mindfulness-based programs: Conceptual issues and empirical findings. Baer, R., Crane, C., Miller, E., et al.[2023]

This study evaluates a teacher training program for mindfulness in 30 upper secondary schools and 13 health and social care schools in Denmark, involving 76 teachers and around 1100 students aged 16 to 24, aiming to improve students' mental well-being over 6 months.

The primary outcome will measure changes in mental well-being using the SWEMWBS scale, with additional evaluations for a vulnerable subgroup of students, highlighting the potential for mindfulness training to enhance mental health in educational settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On Top of Everything: a study protocol for a cluster-randomised controlled trial testing a teacher training programme to teach mindfulness among students in Danish upper secondary schools and schools of health and social care. Beck, MS., Juul, L., Frydenberg, M., et al.[2023]

A school program was developed in Italy to promote mental health and prevent mental illness, featuring a manual with 18 chapters focused on essential skills like communication, problem-solving, and stress management.

The manual was positively received by 253 students across 10 high schools and 1 middle school, indicating its acceptability, while its effectiveness in promoting mental health is still under evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A student manual for promoting mental health among high school students. Gigantesco, A., Del Re, D., Cascavilla, I.[2019]

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 Steps to Leaps initiative, launched by Purdue University in 2019, aims to enhance student well-being by providing resources to build resilience and establish lifelong success habits.

The initiative focuses on five key pillars: well-being, leadership/professional development, impact, networks, and grit, and has generated twelve important lessons from its two years of implementation, highlighting its collaborative approach with students and staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A holistic approach to campus well-being: Steps to Leaps at Purdue University. McCuskey, B., Zhang, F.[2022]

The nurse-led mind caring youth activist program in a rural Thai school positively impacted the mental health of participating students, with 42 youth activists reporting improvements in their well-being.

Teachers also showed a more positive attitude towards addressing students' mental health needs, while nursing students gained confidence and self-awareness through their involvement, indicating the program's effectiveness in fostering a supportive school environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early findings of a nurse-led youth activist program in mind caring. Aekwarangkoon, S., LeClair, J., Oakley, LD.[2023]

The HealthCorps program significantly improved knowledge in nutrition, mental health, and physical activity among 2255 high school students in New York City, indicating its effectiveness in educational outreach.

Behavioral changes were also noted, with boys increasing their fruit and vegetable intake and girls showing improved acceptance of new foods and reduced consumption of sugary drinks, highlighting the program's impact on healthy eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behaviors and Knowledge of HealthCorps New York City High School Students: Nutrition, Mental Health, and Physical Activity. Heo, M., Irvin, E., Ostrovsky, N., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness-based intervention on psychotic symptoms for patients with schizophrenia: A meta-analysis of randomized controlled trials. [2021]

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

Mindfulness Meditation and Anxiety in Adolescents on an Inpatient Psychiatric Unit. [2021]

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

Mindfulness training in a heterogeneous psychiatric sample: outcome evaluation and comparison of different diagnostic groups. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based group therapy: Impact on psychiatrically hospitalized adolescents. [2019]

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

Taming the adolescent mind: a randomised controlled trial examining clinical efficacy of an adolescent mindfulness-based group programme. [2020]

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

Implementation of a teacher-led mindfulness program in a low-income pre- and early-elementary school as part of a trauma-responsive, resilience-building community initiative. [2021]

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

Factors that Influenced Adoption of a School-Based Trauma-Informed Universal Mental Health Intervention. [2021]

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

Doing no harm in mindfulness-based programs: Conceptual issues and empirical findings. [2023]

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

On Top of Everything: a study protocol for a cluster-randomised controlled trial testing a teacher training programme to teach mindfulness among students in Danish upper secondary schools and schools of health and social care. [2023]

10. Italy pubmed.ncbi.nlm.nih.gov

A student manual for promoting mental health among high school students. [2019]

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

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

12. Switzerland pubmed.ncbi.nlm.nih.gov

A holistic approach to campus well-being: Steps to Leaps at Purdue University. [2022]

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

Early findings of a nurse-led youth activist program in mind caring. [2023]

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

Behaviors and Knowledge of HealthCorps New York City High School Students: Nutrition, Mental Health, and Physical Activity. [2018]