An interventional study of Leadership, Engagement, and youth Action Program with Mindfulness and EnvisionIT in Adolescent Behavior Problem and Mental Health Wellness 1, sponsored by Boston University Charles River Campus. Recruiting at 3 sites in United States. Open to participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Boston University Charles River Campus · Not applicable, Interventional, and Prevention
The current study tests the feasibility and effectiveness of a youth intervention designed to provide meaningful leadership opportunities through the acquisition of leadership skills as well as mindfulness practice, LEAP: Leadership, Engagement, and youth Action Program with Mindfulness.
The goal of this project is to determine whether the Leadership, Engagement, and youth Action Program with Mindfulness (LEAP) curriculum, which was developed with youth, is a feasible and effective intervention for fostering leadership and well-being. The investigators seek to understand whether LEAP can support wellbeing for youth as a strategy to increase youth mental, emotional, and behavioral (MEB) health.
The LEAP study will determine whether a 14-session program designed to provide leadership and mindfulness skills to youth is an effective and feasible intervention. The curriculum consists of 14 two-hour sessions delivered after school. The comparison group will take part in EnvisionIT, a college and career readiness program designed for students in grades 6 through 12. EnvisionIT aims to prepare students with essential skills including digital literacy, and college and career readiness. The comparison group will also have 14 two-hour group sessions. Both LEAP and EnvisionIT will be delivered by trained facilitators. All participants in LEAP and EnvisionIT will be assessed at four time points; facilitators will also complete interviews post-intervention and provide feedback on data fidelity and acceptability following each session. This record reports on the UH3 phase of the grant.
305 studies on the registry are indexed under Adolescent Behavior; 47 are open to participants now.
This study's planned enrollment of 504 is above the median of 172 across 256 interventional studies indexed under Adolescent Behavior.
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Exclusion Criteria:
The Leadership, Engagement, and youth Action Program with Mindfulness intervention (LEAP) consists of 14 sessions focused on youth leadership and mindfulness.
Behavioral: Leadership, Engagement, and youth Action Program with Mindfulness
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.
Behavioral: EnvisionIT
The Leadership, Engagement, and youth Action Program with Mindfulness intervention (LEAP) was designed and co-created with youth to improve youth well-being by enhancing leadership opportunities and by developing mindfulness in day-to-day life. LEAP seeks to foster these improvements in youth and to increase youth mental, emotional, and behavioral health. Youth voice is incorporated into the intervention, with facilitators leading the first 7 sessions, and youth leading the remainder.
Also known as: LEAP
Participants in this arm will receive 14 sessions of EnvisionIT training, focused on preparing students with essential skills including digital literacy through competency in information technology, financial literacy, English language arts skills, and college and career readiness. All sessions will be delivered by facilitators trained in EnvisionIT.
Engagement, Perseverance, Optimism, Connectedness, and Happiness (EPOCH; Kern et al., 2016) measure of adolescent wellbeing
20-item, 5-point scale measuring five positive characteristics that support higher levels of wellbeing: Engagement, Perseverance, Optimism, Connectedness, and Happiness. The scale range is 1-5, higher scores indicate better wellbeing.
Time frame: Baseline, 2-3 months, 6 months, 9 months
Strengths and Difficulties Questionnaire (SDQ; Goodman, 2001)
25 item multiple choice questionnaire that measures internalizing and externalizing problems and prosocial behavior (emotional, conduct, hyperactivity-inattention, peer, prosocial). The scale range is 0-40, higher scores indicate worse difficulties.
Time frame: Baseline, 2-3 months, 6 months, 9 months
Self-Rated Health 12-item Short-Form Survey (SF-12; Ware et al., 1996)
12 item 5-point survey measuring general health, asking about overall health self-rating, ability to do daily activities, energy levels, and physical and emotional limitations. The scale range is 0-100, higher scores indicate better health.
Time frame: Baseline, 2-3 months, 6 months, 9 months
Student Career Construction Inventory (Savickas, 2018)
18 item measure 5-point survey measuring crystallizing a vocational self-concept, exploring to gather information about occupations, deciding to commit to an occupational choice, and preparing to implement that choice. Scale scores range from 1-5, with higher scores indicating greater focus on each of the four tasks of career choice construction.
Time frame: Baseline, 2-3 months, 6 months, 9 months
Vocational Skills Self-Efficacy (VSSE; McWhirter et al., 2000)
29 item 5-point survey measuring level of confidence to establish and work toward job goals. Scale scores range from 29-145, with higher scores indicating greater vocational self-efficacy.
Time frame: Baseline, 2-3 months, 6 months, 9 months
Plan to share: Yes — Determinations will be made on a case-by-case basis of what type of data can be shared while maintaining confidentiality of respondents. The investigators are still establishing a plan for data sharing.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Data will be shared after findings for primary outcomes are published. Time frame for sharing will be based on requests, based on recommendations from the funding agency.
Access criteria: Determinations will be made on a case-by-case basis of what type of data can be shared while maintaining confidentiality of respondents. Any data shared will be de-identified and will follow established systems for security in data use.
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