Mindful Movement Intervention (MMI)NCT05118932
Examining Effects of Holistic School Enrichment Programs
A study testing Mindful Movement Intervention in people with Mindful Movement Intervention (MMI), run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindful Movement Intervention (MMI)
- What is being tested?
- Mindful Movement Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 May 2017to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students must be between the ages 7 years, 0 months and 15 years, 11 months, 30 days.
- Students with a diagnosis of depression, anxiety, autism, oppositional defiant disorder, and post traumatic stress disorder can be included in the research study
- Students taking stimulant medications and all other psychoactive medications can be included in the research study.
- Students in general education classrooms with supports, aides, and/or pull-outs
Who cannot join
- 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.
- Students in foster care
- Students who are or may be pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kennedy Krieger Institute
Baltimore, Maryland, 21205
City Neighbors Charter School
Baltimore, Maryland, 21206
About this study
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)
- Being tested
- Mindful Movement Intervention
- Keywords
- Mindfulness, Attention Deficit Hyperactivity Disorder (ADHD)
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Movement InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Movement Intervention | Experimental | 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. Receives: Behavioral: Mindful Movement Intervention |
| Mindful Movement Intervention Family Based Component | Experimental | 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. Receives: Behavioral: Mindful Movement Intervention |
| Mindful Movement Intervention Peer to Peer Mentorship Component | Experimental | In this additional component, participants will have the opportunity to become student instructors and lead younger students in modified instructional classes. Receives: Behavioral: Mindful Movement Intervention |
| Mindful Movement Intervention Community Education Component | Experimental | 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. Receives: Behavioral: Mindful Movement Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dimensional Assessment of the Evolution of Attention-Deficit/Hyperactivity Symptoms
The Strengths and Weaknesses of ADHD-symptoms and Normal-behavior (SWAN) rating scale has been developed to measure children's attention skills as well as emotional and behavioral regulatory control. The seven-point questionnaire ranges from +3 (far below average) to -3 (far above average).
Parent and teacher versions of the SWAN will be collected for each participant and subscale and total scores on the SWAN will be assessed at the start of the intervention (month 0), midway through the intervention (month 4) and at the end of the intervention (month 9).
Measured: 9 months
Assessment of the Evolution of Attention-Deficit/Hyperactivity Symptoms
The DuPaul rating scale is used to assess ADHD related behaviors over the past six months. The 18-item scale uses a 4-point Likert scale with 0 = Not at all and 3 = Very Often.
Parent and teacher versions the DuPaul will be collected for each participant and subscale and total scores on the DuPaul will be assessed at the start of the intervention (month 0), midway through the intervention (month 4) and at the end of the intervention (month 9).
Measured: 9 months
Secondary outcomes (2)
Evolution of Executive Functioning Skills
The evolution of executive functioning skills will be assessed with the Delis-Kaplan Executive Function System (DKEFS) Trails.
The DKEFS number-letter switching score will be assessed at the start of the intervention (month 0), midway through the intervention (month 4) and at the end of the intervention (month 9).
Measured: 9 months
Evolution of Inhibitory Control
The evolution of inhibitory control will be assessed with a Simple Go/No-Go task.
The commission error rate and reaction time variability on the Go/No-Go task will be assessed at the start of the intervention (month 0), midway through the intervention (month 4) and at the end of the intervention (month 9).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start22 May 2017
- Primary completion1 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mindful Movement Intervention (MMI)Studies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All students will be receiving the same single intervention.
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Stewart Mostofsky, MD, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118932
- Sponsor's protocol ID
- IRB00129138
- Status last verified
- Sep 2024
- First submitted
- 21 Oct 2021
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Effects of Holistic School Enrichment Programs
- ClinicalTrials.gov ID
- NCT05118932
- Acronym / sponsor ID
- IRB00129138
- Conditions
- Mindful Movement Intervention (MMI)
- Keywords
- Mindfulness, Attention Deficit Hyperactivity Disorder (ADHD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 22 May 2017 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 12 Nov 2021 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- All students will be receiving the same single intervention.
| Arm | Type | Receives |
|---|---|---|
| Mindful Movement Intervention | Experimental | Behavioral: Mindful Movement InterventionThe 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. |
| Mindful Movement Intervention Family Based Component | Experimental | Behavioral: Mindful Movement InterventionIn 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. |
| Mindful Movement Intervention Peer to Peer Mentorship Component | Experimental | Behavioral: Mindful Movement InterventionIn this additional component, participants will have the opportunity to become student instructors and lead younger students in modified instructional classes. |
| Mindful Movement Intervention Community Education Component | Experimental | Behavioral: Mindful Movement InterventionIn 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. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Students must be between the ages 7 years, 0 months and 15 years, 11 months, 30 days.
- Students with a diagnosis of depression, anxiety, autism, oppositional defiant disorder, and post traumatic stress disorder can be included in the research study
- Students taking stimulant medications and all other psychoactive medications can be included in the research study.
- Students in general education classrooms with supports, aides, and/or pull-outs
Key exclusion criteria (8 listed)
- Diagnosis of...
- Students in foster care
- Students who are or may be pregnant
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 |
|---|---|---|
| Mindful Movement InterventionThere 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. | Behavioural | Mindful Movement Intervention, Mindful Movement Intervention Community Education Component, Mindful Movement Intervention Family Based Component, Mindful Movement Intervention Peer to Peer Mentorship Component |
Primary outcome
Dimensional Assessment of the Evolution of Attention-Deficit/Hyperactivity Symptoms
Time frame: 9 months
The Strengths and Weaknesses of ADHD-symptoms and Normal-behavior (SWAN) rating scale has been developed to measure children's attention skills as well as emotional and behavioral regulatory control. The seven-point questionnaire ranges from +3 (far below average) to -3 (far above average). Parent and teacher versions of the SWAN will be collected for each participant and subscale and total scores on the SWAN will be assessed at the start of the intervention (month 0), midway through the intervention (month 4) and at the end of the intervention (month 9).
Assessment of the Evolution of Attention-Deficit/Hyperactivity Symptoms
Time frame: 9 months
The DuPaul rating scale is used to assess ADHD related behaviors over the past six months. The 18-item scale uses a 4-point Likert scale with 0 = Not at all and 3 = Very Often. Parent and teacher versions the DuPaul will be collected for each participant and subscale and total scores on the DuPaul will be assessed at the start of the intervention (month 0), midway through the intervention (month 4) and at the end of the intervention (month 9).
2 secondary outcomes
Evolution of Executive Functioning Skills
Time frame: 9 months
Evolution of Inhibitory Control
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
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. This study is not recruiting at the moment.
Stewart Mostofsky, MD principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Movement Intervention in people with Mindful Movement Intervention (MMI), run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 2 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dimensional Assessment of the Evolution of Attention-Deficit/Hyperactivity Symptoms (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2024; AzTrials last refreshed its copy on 2 Nov 2026.