NCT06227403

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

January 5, 2024

Last Update Submit

August 1, 2025

Conditions

Keywords

mindfulnessyouth leadershipyouth wellbeing

Outcome Measures

Primary Outcomes (8)

  • Mental Health Continuum - Short Form

    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.

    Baseline, 2-3 months

  • Engagement, Perseverance, Optimism, Connectedness, and Happiness (EPOCH) 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.

    Baseline, 2-3 months

  • Social Emotional Health Survey: Belief in Self-Domain

    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

  • Strengths and Difficulties Questionnaire

    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

  • Self-Rated Health

    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

  • Student Career Construction Inventory

    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.

    Baseline, 2-3 months

  • Vocational Skills Self-Efficacy

    A 37 item, 5-point scale that measures vocational competency. The scale range is 1-5, higher scores indicate better vocational skills self-efficacy.

    Baseline, 2-3 months

  • Information and Communications Technology (ICT) Literacy Pretest-Posttest

    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

Study Arms (2)

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.

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.

Behavioral: EnvisionIT

Interventions

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.

Leadership, Engagement, and youth Action Program with Mindfulness
EnvisionITBEHAVIORAL

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.

EnvisionIT

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents ages 14-18 in grades 9-12 enrolled in collaborating sites, either in Massachusetts or Illinois.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Illinois Chicago

Chicago, Illinois, 60608, United States

Location

METCO

Boston, Massachusetts, 02119, United States

Location

MeSH Terms

Conditions

Adolescent Behavior

Interventions

LeadershipMindfulness

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Personnel ManagementOrganization and AdministrationHealth Services AdministrationCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jennifer G Green, PhD

    Boston University

    PRINCIPAL INVESTIGATOR
  • Mario Cruz-Gonzalez, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessors will be masked to study condition.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Wheelock College of Education & Human Development

Study Record Dates

First Submitted

January 5, 2024

First Posted

January 26, 2024

Study Start

December 15, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

August 6, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Data for the study UG3 Phase are for pilot and feasibility purposes and will not be shared with other researchers.

Locations