- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06736522
Future Leaders Program: Testing a Youth Leadership, Engagement, and Mindfulness Program (FLP)
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 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer Greif Green, PhD
- Phone Number: 617-353-3253
- Email: jggreen@bu.edu
Study Contact Backup
- Name: Mario Cruz-Gonzalez, PhD
- Phone Number: 617-513-8762
- Email: mcruzgonzalez@mgh.harvard.edu
Study Locations
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Illinois
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Chicago, Illinois, United States, 60608
- Recruiting
- University of Illinois, Chicago
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Contact:
- Dana Rusch, PhD
- Phone Number: 312-413-1708
- Email: drusch1@uic.edu
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Principal Investigator:
- Dana Rusch, PhD
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Recruiting
- Boston University
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Contact:
- Jennifer Green
- Phone Number: 617-353-3253
- Email: jggreen@bu.edu
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Boston, Massachusetts, United States, 02119
- Recruiting
- METCO
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Contact:
- Wilmary Tejeda, MPA
- Phone Number: 119 617-427-1545
- Email: wtejeda@metcoinc.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescents ages 14 and older in grades 9-12 during the Fall/Winter or in grades 9-11 during the Spring
- Enrolled in a partner site in Massachusetts or Illinois
- Adolescents are only included with parent consent and youth assent if they are under the age of 18. Adolescents at least 18 years old can provide consent.
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)
- They are not in grades 9-12 at a partner site
- Parent/guardian has a preferred consent 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.
|
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Engagement, Perseverance, Optimism, Connectedness, and Happiness (EPOCH; Kern et al., 2016) measure of adolescent wellbeing
Time Frame: Baseline, 2-3 months, 6 months, 9 months
|
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, 6 months, 9 months
|
|
Strengths and Difficulties Questionnaire (SDQ; Goodman, 2001)
Time Frame: Baseline, 2-3 months, 6 months, 9 months
|
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.
|
Baseline, 2-3 months, 6 months, 9 months
|
|
Self-Rated Health 12-item Short-Form Survey (SF-12; Ware et al., 1996)
Time Frame: Baseline, 2-3 months, 6 months, 9 months
|
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.
|
Baseline, 2-3 months, 6 months, 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Student Career Construction Inventory (Savickas, 2018)
Time Frame: Baseline, 2-3 months, 6 months, 9 months
|
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.
|
Baseline, 2-3 months, 6 months, 9 months
|
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Vocational Skills Self-Efficacy (VSSE; McWhirter et al., 2000)
Time Frame: Baseline, 2-3 months, 6 months, 9 months
|
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.
|
Baseline, 2-3 months, 6 months, 9 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mario Cruz-Gonzalez, PhD, Massachusetts General Hospital
- Principal Investigator: Jennifer Greif Green, Ph, Boston University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7018E
- 4UH3AT012530 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
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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