Examining Effects of Holistic School Enrichment Programs

NCT ID: NCT05118932

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-22
• Study Completion Date: 2024-08-01

Brief Summary

The investigators propose to evaluate the efficacy of a Mindful Movement Intervention (MMI) within the Baltimore City Public School (BCPS) system. The goal is to help at-risk youth improve skills important to attentional, behavioral, motor, and emotional control through engagement of mindful movement practices.

To assess the feasibility and efficacy of the program, standardized assessments will be conducted at three time points: the beginning of the school year at the start of the intervention (early September), at the mid-year point (late January), and prior to the end of the school year (early June). During these assessments, participants will be pulled out of their academic classes for brief sessions (1 hour) in which they will complete assessments of attentional, behavioral, motor, and emotional control. At these assessment points, parents and teachers will complete rating forms about the children including assessments of emotional, behavioral, and attention regulation.

Research participants will have the option to reinforce mindful movement practices using a family-based curriculum, participating in peer mentorship, and supporting the development of community educational materials.

Conditions

Mindful Movement Intervention (MMI)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindful Movement Intervention

The Mindful Movement Intervention (MMI) targets improved attentional, behavioral and emotional regulation through engagement of the motor system and mindful practice in school-age children. For this project, children will participate in the MMI twice a week for 45 minutes a session for the duration of the academic year. The intervention will be held during school hours to make it more accessible to all students and require fewer additional resources.

Briefly, there are five components that make-up the Mindful Movement Intervention: Biomechanical Warm-ups, Yoga postures, a modified Tai Chi sequence, Imaginative Play, and Reflection.

One goal of this intervention is to help children to develop the skills needed to cope with naturally occurring changes and to adapt to their environment in a mindful, non-reactive manner. In this context, students are learning to control and manage their attention, behavior and emotion through implicit procedural learning.

Group Type: EXPERIMENTAL

Mindful Movement Intervention

Intervention Type: BEHAVIORAL

There are five components that together make-up the Mindful Movement Intervention: Biomechanical Warm-ups, Yoga postures, modified Tai Chi sequence, Imaginative Play, and Reflection. During the year, participants will learn a "Simplified" Form of a classic Tai Chi sequence. Yoga movements will be used to prepare participants for the nuanced movements of Tai Chi practice, with both Yoga and Tai Chi providing a physical framework in which participants can track their own progress and begin to understand how to better regulate their attention, behavior and emotional responses. Imaginative Play and Reflection Activities are used to stimulate a deeper curiosity in participants about the everyday use and employment of mindfulness practice and to engage participants.

Mindful Movement Intervention Family Based Component

In this additional component, participants and their families will have access to monthly Mindful Movement activities intended to reinforce concepts discussed in Mindful Movement class and foster familial relationships. The family-based component will include access to lesson plans and accompanying resources (e.g., videos, worksheets, audio tracks) once a month from October through May, that offer strategies to improve awareness of thoughts, emotions, and body. Families will also be expected to track their adherence to the lesson plans and provide feedback via a survey.

Group Type: EXPERIMENTAL

Mindful Movement Intervention

Intervention Type: BEHAVIORAL

There are five components that together make-up the Mindful Movement Intervention: Biomechanical Warm-ups, Yoga postures, modified Tai Chi sequence, Imaginative Play, and Reflection. During the year, participants will learn a "Simplified" Form of a classic Tai Chi sequence. Yoga movements will be used to prepare participants for the nuanced movements of Tai Chi practice, with both Yoga and Tai Chi providing a physical framework in which participants can track their own progress and begin to understand how to better regulate their attention, behavior and emotional responses. Imaginative Play and Reflection Activities are used to stimulate a deeper curiosity in participants about the everyday use and employment of mindfulness practice and to engage participants.

Mindful Movement Intervention Peer to Peer Mentorship Component

In this additional component, participants will have the opportunity to become student instructors and lead younger students in modified instructional classes.

Group Type: EXPERIMENTAL

Mindful Movement Intervention

Intervention Type: BEHAVIORAL

There are five components that together make-up the Mindful Movement Intervention: Biomechanical Warm-ups, Yoga postures, modified Tai Chi sequence, Imaginative Play, and Reflection. During the year, participants will learn a "Simplified" Form of a classic Tai Chi sequence. Yoga movements will be used to prepare participants for the nuanced movements of Tai Chi practice, with both Yoga and Tai Chi providing a physical framework in which participants can track their own progress and begin to understand how to better regulate their attention, behavior and emotional responses. Imaginative Play and Reflection Activities are used to stimulate a deeper curiosity in participants about the everyday use and employment of mindfulness practice and to engage participants.

Mindful Movement Intervention Community Education Component

In this additional component, participants will have the option to assist with the development of an instructional video that showcases students in the Mindful Movement program demonstrating mindful movement practices such as breathing techniques, yoga poses, and T'ai Chi movements.

Group Type: EXPERIMENTAL

Mindful Movement Intervention

Intervention Type: BEHAVIORAL

There are five components that together make-up the Mindful Movement Intervention: Biomechanical Warm-ups, Yoga postures, modified Tai Chi sequence, Imaginative Play, and Reflection. During the year, participants will learn a "Simplified" Form of a classic Tai Chi sequence. Yoga movements will be used to prepare participants for the nuanced movements of Tai Chi practice, with both Yoga and Tai Chi providing a physical framework in which participants can track their own progress and begin to understand how to better regulate their attention, behavior and emotional responses. Imaginative Play and Reflection Activities are used to stimulate a deeper curiosity in participants about the everyday use and employment of mindfulness practice and to engage participants.

Interventions

Mindful Movement Intervention

There are five components that together make-up the Mindful Movement Intervention: Biomechanical Warm-ups, Yoga postures, modified Tai Chi sequence, Imaginative Play, and Reflection. During the year, participants will learn a "Simplified" Form of a classic Tai Chi sequence. Yoga movements will be used to prepare participants for the nuanced movements of Tai Chi practice, with both Yoga and Tai Chi providing a physical framework in which participants can track their own progress and begin to understand how to better regulate their attention, behavior and emotional responses. Imaginative Play and Reflection Activities are used to stimulate a deeper curiosity in participants about the everyday use and employment of mindfulness practice and to engage participants.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Students must be between the ages 7 years, 0 months and 15 years, 11 months, 30 days.

2. Students with a diagnosis of depression, anxiety, autism, oppositional defiant disorder, and post traumatic stress disorder can be included in the research study

3. Students taking stimulant medications and all other psychoactive medications can be included in the research study.

4. Students in general education classrooms with supports, aides, and/or pull-outs

Exclusion Criteria

1. Diagnosis of...

• intellectual disability
• a neurological disorder (e.g., epilepsy, cerebral palsy, traumatic brain injury, Tourette Syndrome)
• conduct disorder or a recorded history of symptoms consistent with conduct disorder
• a documented hearing impairment ≥ 25 dB loss in either ear
• significant learning difficulties that require a special education plan.

2. Students in foster care

3. Students who are or may be pregnant

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stewart Mostofsky, MD

Role: PRINCIPAL_INVESTIGATOR

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Locations

Kennedy Krieger Institute

Baltimore, Maryland, United States

City Neighbors Charter School

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00129138

Identifier Type: -

Identifier Source: org_study_id