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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the LEAP (Leadership, Engagement, and Youth Activism Program with Mindfulness), which combines leadership skills and mindfulness, can improve mental and emotional health in teens. It compares two programs: the LEAP program and EnvisionIT, which focuses on college and career preparation. Teens in grades 9-12 in Massachusetts or Illinois who can attend all sessions and have parental consent (if under 18) are eligible. The study seeks to discover if these programs can boost youth leadership and overall well-being. As an unphased trial, this study provides a unique opportunity for teens to enhance their leadership skills and emotional health through innovative programs.

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 prior data suggests that this program is safe for youth?

Research shows that the Leadership, Engagement, and Youth Action Program with Mindfulness (LEAP) is designed to boost well-being in young people. While specific safety details for LEAP are not provided, mindfulness and leadership programs are generally safe for participants. These programs teach skills rather than using medication, often resulting in fewer side effects.

Since LEAP includes mindfulness practices, which have been widely studied and found safe for young people, participants are unlikely to face significant risks. Overall, programs like LEAP aim to improve mental and emotional health, suggesting a positive impact on participants' well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Leadership, Engagement, and youth Action Program with Mindfulness (LEAP) because it combines youth leadership training with mindfulness practices, which is a fresh approach compared to traditional mental health programs that often focus solely on therapy or medication. This program is unique in its emphasis on empowering young people to take active roles in their communities and develop leadership skills, which can enhance their mental wellness and resilience. Additionally, integrating mindfulness into the curriculum helps students manage stress and improve focus, setting it apart from standard educational programs that may not address emotional well-being directly.

What evidence suggests that this trial's treatments could be effective for youth mental health?

Research has shown that the Leadership, Engagement, and Youth Action Program with Mindfulness (LEAP), a program under study in this trial, effectively supports young people's well-being. The program combines leadership training with mindfulness exercises to enhance mental, emotional, and behavioral health in youth. Early findings suggest this approach helps young people develop leadership skills while promoting emotional balance and resilience. This dual focus has shown promise in boosting overall mental health among participants. Although more research is needed, early results are encouraging for those interested in improving youth mental wellness through leadership and mindfulness. ^{1 5 6 7 8}

Who Is on the Research Team?

Mario Cruz-Gonzalez, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 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.

They participated in the pilot phase (UG3)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

The Leadership, Engagement, and youth Action Program with Mindfulness intervention (LEAP) consists of 14 sessions focused on youth 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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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 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]

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]

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]

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-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]

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 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]

Citations

1.

reporter.nih.gov

reporter.nih.gov/search/7S3Jh1Ya5USG9yxGiQ_jiA/project-details/11159179

RePORT RePORTER - National Institutes of Health (NIH) |

This study tests the effectiveness of an innovative youth leadership and civic engagement program with a mindfulness component co-constructed with youth of ...

2.

trialx.com

trialx.com/clinical-trials/listings/282846/leadership-engagement-and-youth-activism-program-with-mindfulness-leap/?&geo_lat=42.2836&geo_lng=-71.1295&radius=10&place=Roslindale&user_country=United%20States

Leadership, Engagement, and Youth Activism Program With ...

The LEAP-M study will determine whether a 14-session program designed to provide leadership and mindfulness skills to youth of color is an effective and ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06227403

Leadership, Engagement, and Youth Action Program With ...

We seek to understand whether LEAP can support well-being for youth as a strategy to increase youth mental, emotional, and behavioral (MEB) health. Detailed ...

4.

trialstoday.org

trialstoday.org/trial/NCT06227403

Leadership, Engagement, and Youth Action Program ...

The current study tests the feasibility and effectiveness of a youth intervention designed to provide meaningful leadership opportunities ...

5.

reporter.nih.gov

reporter.nih.gov/project-details/10731997

Can A Youth Civic Leadership, Engagement and ...

Project Summary/Abstract (30 Lines) This study tests the effectiveness of a youth leadership and civic engagement program with a mindfulness component in ...

6.

reporter.nih.gov

reporter.nih.gov/project-details/11194008

Can A Youth Leadership and Mindfulness Program ...

This study tests the effectiveness of a youth leadership program with a mindfulness component in improving the mental, emotional, and behavioral (MEB) ...

7.

app.trialscreen.org

app.trialscreen.org/trials/future-leaders-program-trial-nct06736522

Future Leaders Program: Testing a Youth Leadership ...

Potential benefits for participants include acquiring leadership skills, developing civic engagement and activism, practicing mindfulness, and supporting mental ...

8.

withpower.com

withpower.com/trial/leadership-program-for-mental-health-wellness-d58b5

Leadership Program for Mental Health Wellness (FLP Trial)

This treatment is unique because it combines leadership and activism with mindfulness practices, specifically targeting youth in a school setting to enhance ...