- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06227403
Leadership, Engagement, and Youth Action Program With Mindfulness (LEAP)
Can A Youth Leadership and Mindfulness Program Support Well-being in Adolescence?
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 our proposal 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. We seek to understand whether LEAP can support well-being for youth as a strategy to increase youth mental, emotional, and behavioral (MEB) health.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60608
- University of Illinois Chicago
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Massachusetts
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Boston, Massachusetts, United States, 02119
- METCO
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Adolescents ages 14-18 in grades 9-12 enrolled in collaborating sites, either in Massachusetts or Illinois.
Exclusion Criteria:
- Adolescents who are not available to commit to the intervention schedule.
- Adolescents who are not in grades 9-12.
- Parents/guardians with preferred language other than English or Spanish.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: EnvisionIT
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.
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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.
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Experimental: Leadership, Engagement, and youth Action Program with Mindfulness
The Leadership, Engagement, and youth Action Program with Mindfulness intervention (LEAP) consists of 14 sessions focused on youth leadership and mindfulness.
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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 as a strategy to increase mental, emotional, and behavioral health.
Youth voice is incorporated into the intervention, with facilitators leading the first 7 sessions, and youth leading the remainder.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mental Health Continuum - Short Form
Time Frame: Baseline, 2-3 months
|
14-item, 6-point scale that measures emotional, social, and psychological wellbeing through frequency of experiencing each symptom of positive mental health.
The scale range is 0-70, higher scores indicate better mental health.
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Baseline, 2-3 months
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Engagement, Perseverance, Optimism, Connectedness, and Happiness (EPOCH) measure of adolescent wellbeing
Time Frame: Baseline, 2-3 months
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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.
|
Baseline, 2-3 months
|
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Social Emotional Health Survey: Belief in Self-Domain
Time Frame: Baseline, 2-3 months
|
9 item, 4-point measure of core psychological assets, measuring self-efficacy, self-awareness, and persistence.
The scale range is 9-36, higher scores indicate better social emotional health.
|
Baseline, 2-3 months
|
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Strengths and Difficulties Questionnaire
Time Frame: Baseline, 2-3 months
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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.
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Baseline, 2-3 months
|
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Self-Rated Health
Time Frame: Baseline, 2-3 months
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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.
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Baseline, 2-3 months
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Student Career Construction Inventory
Time Frame: Baseline, 2-3 months
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An 18 item, 4-point scale measuring ability to crystallize vocational self-concepts, explore information gathering about occupations, and preparing to implement that choice.
The scale range is 1-5, higher scores indicate better career outcomes.
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Baseline, 2-3 months
|
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Vocational Skills Self-Efficacy
Time Frame: Baseline, 2-3 months
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A 37 item, 5-point scale that measures vocational competency.
The scale range is 1-5, higher scores indicate better vocational skills self-efficacy.
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Baseline, 2-3 months
|
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Information and Communications Technology (ICT) Literacy Pretest-Posttest
Time Frame: Baseline, 2-3 months
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A 35 item multiple choice questionnaire that measures understanding of tools/mechanics of the internet, research processes, and application to career research.
The scale range is 0-29, higher scores indicate better ICT literacy.
|
Baseline, 2-3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jennifer G Green, PhD, Boston University
- Principal Investigator: Mario Cruz-Gonzalez, PhD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1UG3AT012530-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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