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Mindful Movement Intervention for Mindful Movement Intervention

N/A
Waitlist Available
Led By Stewart Mostofsky, MD, PhD
Research Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Students must be between the ages 7 years, 0 months and 15 years, 11 months, 30 days
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

Study Summary

This trial will help researchers understand if a mindful movement intervention can help at-risk youth improve skills important to attentional, behavioral and emotional control.

Who is the study for?
This trial is for children aged 7 to nearly 16 in Baltimore City Public Schools who may struggle with depression, anxiety, autism, oppositional defiant disorder, or PTSD. It's open to those on stimulant or psychoactive meds and those in general classrooms needing extra help. Kids with neurological issues, intellectual disabilities, conduct disorders, hearing loss over 25 dB, significant learning difficulties requiring special education plans, foster care kids or those pregnant are excluded.Check my eligibility
What is being tested?
The study tests a Mindful Movement Intervention (MMI) aimed at improving attentional, behavioral motor and emotional control among at-risk youth. The efficacy will be measured through assessments conducted three times during the school year: start of intervention (September), mid-year (January), and before summer break (June).See study design
What are the potential side effects?
Since this is not a drug trial but an educational program focusing on mindful movement practices there are no direct medical side effects expected from participation. However participants might experience changes in mood or behavior as they engage with the program.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a student aged between 7 and 15 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of the Evolution of Attention-Deficit/Hyperactivity Symptoms
Dimensional Assessment of the Evolution of Attention-Deficit/Hyperactivity Symptoms
Secondary outcome measures
Evolution of Executive Functioning Skills
Evolution of Inhibitory Control
Other outcome measures
Assessment of Caregiver-Family Quality of Life
Evolution of Caregiver-Reported Emotion Regulation
Evolution of Child-Reported Emotion Regulation
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Mindful Movement Intervention Peer to Peer Mentorship ComponentExperimental Treatment1 Intervention
In this additional component, participants will have the opportunity to become student instructors and lead younger students in modified instructional classes.
Group II: Mindful Movement Intervention Family Based ComponentExperimental Treatment1 Intervention
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 III: Mindful Movement Intervention Community Education ComponentExperimental Treatment1 Intervention
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 IV: Mindful Movement InterventionExperimental Treatment1 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.

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Who is running the clinical trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor
88 Previous Clinical Trials
24,638 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
321 Previous Clinical Trials
401,449 Total Patients Enrolled
National Center for Advancing Translational Science (NCATS)NIH
99 Previous Clinical Trials
36,009 Total Patients Enrolled

Media Library

Mindful Movement Intervention (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05118932 — N/A
Mindful Movement Intervention Research Study Groups: Mindful Movement Intervention Community Education Component, Mindful Movement Intervention, Mindful Movement Intervention Family Based Component, Mindful Movement Intervention Peer to Peer Mentorship Component
Mindful Movement Intervention Clinical Trial 2023: Mindful Movement Intervention Highlights & Side Effects. Trial Name: NCT05118932 — N/A
Mindful Movement Intervention (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05118932 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research accepting participants aged 35 or older?

"The ages of those eligible to participate in this trial range from 7 years old to 15 years old, as stated within the given inclusion criteria."

Answered by AI

Is there an open enrollment period for this clinical trial?

"The trial details on clinicaltrials.gov reveal that this research study is not admitting participants at the moment. It was initially posted in May of 2017 and last revised July 18th 2022, yet a further 1 trails are open for enrollment presently."

Answered by AI

Am I eligible to join this research endeavor?

"This medical experiment will recruit 200 children aged between 7 and 15 years old who have Mindful Movement Intervention (MMI). Furthermore, patients must be within the exact age range of 7.0 months to 15.11 months and 30 days."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Examining Effects of Holistic School Enrichment Programs
2017. "Examining Effects of Holistic School Enrichment Programs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05118932.
~4 spots leftby Jun 2024
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