Adolescent Behavior ProblemFLPNCT06736522
Future Leaders Program: Testing a Youth Leadership, Engagement, and Mindfulness Program
A study testing Leadership, Engagement, and youth Action Program with Mindfulness and EnvisionIT in people with Adolescent Behavior Problem and Mental Health Wellness 1, run by Boston University Charles River Campus at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior Problem, Mental Health Wellness 1
- What is being tested?
- Leadership, Engagement, and youth Action Program with Mindfulness and EnvisionIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Dec 2024to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
METCO
Boston, Massachusetts, 02119
Wilmary Tejeda, MPA, 617-427-1545 ext. 119, wtejeda@metcoinc.org
- Recruiting
Boston University
Boston, Massachusetts, 02215
Jennifer Green, 617-353-3253, jggreen@bu.edu
- Recruiting
University of Illinois, Chicago
Chicago, Illinois, 60608
Dana Rusch, PhD, 312-413-1708, drusch1@uic.edu
Dana Rusch, PhD
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Leadership, Engagement, and youth Action Program with Mindfulness, EnvisionIT
- Keywords
- mindfulness, youth leadership, youth wellbeing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leadership, Engagement, and youth Action Program with MindfulnessBehavioural
Also called LEAP
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.
EnvisionITBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Leadership, Engagement, and youth Action Program with Mindfulness | Experimental | The Leadership, Engagement, and youth Action Program with Mindfulness intervention (LEAP) consists of 14 sessions focused on youth leadership and mindfulness. Receives: Behavioral: Leadership, Engagement, and youth Action Program with Mindfulness |
| EnvisionIT | Active comparator | 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. Receives: Behavioral: EnvisionIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2-3 months, 6 months, 9 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, 2-3 months, 6 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start16 Dec 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent Behavior ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individually Randomized Group Treatment Trial Design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Mario Cruz-Gonzalez, PhD, Principal investigator, Massachusetts General HospitalJennifer Greif Green, Ph, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736522
- Sponsor's protocol ID
- 7018E
- Other IDs
- 4UH3AT012530
- Acronym
- FLP
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Alegria M, Alvarez K, NeMoyer A, Zhen-Duan J, Marsico C, O'Malley IS, Mukthineni R, Porteny T, Herrera CN, Najarro Cermeno J, Kingston K, Sisay E, Trickett E. Development of a Youth Civic Engagement Program: Process and Pilot Testing with a Youth-Partnered Research Team. Am J Community Psychol. 2022 Mar;69(1-2):86-99. doi: 10.1002/ajcp.12548. Epub 2021 Aug 4.
PubMed 34350588
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can A Youth Leadership and Mindfulness Program Support Well-being in Adolescence?
- ClinicalTrials.gov ID
- NCT06736522
- Acronym / sponsor ID
- FLP / 7018E
- Keywords
- mindfulness, youth leadership, youth wellbeing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Individually Randomized Group Treatment Trial Design
| Arm | Type | Receives |
|---|---|---|
| Leadership, Engagement, and youth Action Program with Mindfulness | Experimental | Behavioral: Leadership, Engagement, and youth Action Program with MindfulnessThe Leadership, Engagement, and youth Action Program with Mindfulness intervention (LEAP) consists of 14 sessions focused on youth leadership and mindfulness. |
| EnvisionIT | Active comparator | Behavioral: EnvisionITEnvisionIT 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 may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leadership, Engagement, and youth Action Program with MindfulnessAlso: LEAPThe 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. | Behavioural | Leadership, Engagement, and youth Action Program with Mindfulness |
| EnvisionITParticipants 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. | Behavioural | EnvisionIT |
Primary outcome
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.
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.
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.
2 secondary outcomes
Student Career Construction Inventory (Savickas, 2018)
Time frame: Baseline, 2-3 months, 6 months, 9 months
Vocational Skills Self-Efficacy (VSSE; McWhirter et al., 2000)
Time frame: Baseline, 2-3 months, 6 months, 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 34350588Alegria M, Alvarez K, NeMoyer A, Zhen-Duan J, Marsico C, O'Malley IS, Mukthineni R, Porteny T, Herrera CN, Najarro Cermeno J, Kingston K, Sisay E, Trickett E. Development of a Youth Civic Engagement Program: Process and Pilot Testing with a Youth-Partnered Research Team. Am J Community Psychol. 2022 Mar;69(1-2):86-99. doi: 10.1002/ajcp.12548. Epub 2021 Aug 4.
- Individual participant dataSharing planned: 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.
Related trials for Adolescent Behavior Problem
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
RecruitingPhase 2
Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety
Psychiatric Disorders, Anxiety Disorders
Active, not recruiting
Parent Intervention for Psychiatrically-Hospitalized Youth
Adolescent - Emotional Problem, Suicide and Self-harm
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
RecruitingObservational study
Proximal Risk for Suicide in Adolescents
Suicide, Mental Health Issue
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mario Cruz-Gonzalez, PhD principal investigator
Massachusetts General Hospital
Jennifer Greif Green, Ph principal investigator
Boston University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leadership, Engagement, and youth Action Program with Mindfulness and EnvisionIT in people with Adolescent Behavior Problem and Mental Health Wellness 1, run by Boston University Charles River Campus at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Greif Green, PhD (617-353-3253, jggreen@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06736522, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.