Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-28 @ 1:13 AM
Study NCT ID:
NCT06227403
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2024-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Leadership, Engagement, and Youth Action Program With Mindfulness (LEAP)
Sponsor:
Boston University Charles River Campus
Organization:
Study Overview
Official Title:
Can A Youth Leadership and Mindfulness Program Support Well-being in Adolescence?
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 two time points assessing program outcomes; facilitators will also complete interviews post-intervention and provide feedback on data fidelity and acceptability following each session. This record reports on the UG3 pilot phase and will be amended for a UH3 phase.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: