Developmental DisabilityNCT07088003
Yoga as Mindful Movement: A Randomized Controlled Trial
A study testing Yoga as Mindful Movement and Adapted Physical Education in people with Developmental Disability, run by University at Buffalo at 1 site in United States.
Trial summary
This study aimed to close an existing research gap by exploring the impact of a school-based mindful yoga program, Yoga as Mindful Movement (YMM), on foundational motor skills, social-emotional competence, classroom behavior, attention, and impulse control of students with various developmental disabilities in… Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Developmental Disability
- What is being tested?
- Yoga as Mindful Movement and Adapted Physical Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to 2 Mar 2022
- 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 5 to 7 years
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria: (a) Actively attending the participating school (indicating the presence of at least one developmental disability), (b) enrolled in kindergarten, first, or second grade, (c) part of a 6:1:3 classroom, (d) between the ages of 5 and 7, and (e) English-speaking
Exclusion Criteria: (a) Participant's family opted them out of the study, (b) participants was absent for three consecutive Yoga as Mindful Movement (YMM) classes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Yoga as Mindful Movement: A Randomized Controlled Trial for Early Elementary School-Aged Children With Developmental Disabilities
This study aimed to close an existing research gap by exploring the impact of a school-based mindful yoga program, Yoga as Mindful Movement (YMM), on foundational motor skills, social-emotional competence, classroom behavior, attention, and impulse control of students with various developmental disabilities in kindergarten, first-, and second-grade (K-2).
- Conditions
- Developmental Disability
- Being tested
- Yoga as Mindful Movement, Adapted Physical Education
- Keywords
- Yoga, Mindfulness, Developmental Disability, Children, Early Elementary School
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga as Mindful MovementBehavioural
YMM is an 8-week hybrid (in-person and virtual) school-based mindful yoga program (modified from its original 10-week, in-person design due to complications of COVID-19) informed by the teachings of Radiant Child Yoga. It was designed to teach students about self regulation through the integration of movement, breath, and present-moment awareness. It was delivered in the form of three, 30-minute YMM sessions each week by the same instructor-an individual with training and experience as an occupational therapist and yoga teacher through the Yoga Alliance and Radiant Child Yoga.
Adapted Physical EducationBehavioural
Adapted PE took place daily (Monday-Friday) for one hour and consisted of lessons on movement skills such as catching, throwing, aiming, running, jumping, skating, and dancing through various activities and games.
| Study group | Role | What they receive |
|---|---|---|
| Yoga as Mindful Movement | Experimental | Not described Receives: Behavioral: Yoga as Mindful Movement |
| Adapted Physical Education | Active comparator | Not described Receives: Behavioral: Adapted Physical Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Assessment Battery for Children, Second Edition
The Movement Assessment Battery for Children, Second Edition measures children's motor performance in physical tasks (e.g., threading beads, catching a ball, walking heel-to-toe) through direct observation. Quantifiable criteria (e.g., task completion time, number of successful attempts, number of errors) is measured.
Measured: From pre-enrollment (2 weeks before 8-week intervention) to post-enrollment (2 weeks after intervention's conclusion).
Devereux Student Strengths Assessment-Mini
This questionnaire asks assessors (classroom instructional staff) to rate how often a student displays certain behaviors (e.g., taking an active role in learning, making a suggestion or request in a polite way) in the past four weeks that correspond to social-emotional, cognitive, and interpersonal skills. Behaviors are rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very Frequently). A higher score indicates more social-emotional competence.
Measured: From pre-enrollment (2 weeks before 8-week intervention) to post-enrollment (2 weeks after intervention's conclusion).
Child Behavior Rating Scale
The Child Behavior Rating Scale asks classroom instructional staff to indicate how often each student exhibits certain behaviors (e.g., returning to an unfinished task after interruption, attempting new challenging tasks) over the past week. This was completed using a 5-point Likert scale ranging from 1 (Never) to 5 (Always), with a higher score indicating positive behavior.
Measured: From pre-enrollment (2 weeks before 8-week intervention) to post-enrollment (2 weeks after intervention's conclusion).
Head-Toes-Knees-Shoulders-Revised (HTKS-R) modified for Neurodiverse Learners (HTNL)
Measured: From pre-enrollment (2 weeks before 8-week intervention) to post-enrollment (2 weeks after intervention's conclusion).
Secondary outcomes (1)
Classroom Observations
Post-YMM (or adapted PE) session classroom observations of participants' behavior were conducted by two members of the research team who were masked to study conditions and not part of the school's instructional staff. Behaviors in nine categories (i.e., disrupting one's own or others' learning activity, demonstrating aggression toward staff or peers, engaging in a task, being prompted by an adult, affect, and wearing or not wearing a face mask-required due to COVID-19) were tracked and coded quantitatively. During each 30-minute observation block, three students per classroom were observed twice in 5-minute increments, for a total of 10 minutes each. This structure was implemented to capture potential variations in students' behavior over time. Because most classrooms had six students, the remaining three students were observed in the same manner the next time an observer visited the classroom.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start4 Oct 2021
- Primary completion14 Feb 2022
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DisabilityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Cook-Cottone, University at Buffalo
- Investigators
- Catherine P. Cook-Cottone, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088003
- Sponsor's protocol ID
- UBuffalo
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared due to concerns about participant privacy and limitations in the informed consent that prevent broader data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga as Mindful Movement: A Randomized Controlled Trial for Early Elementary School-Aged Children With Developmental Disabilities
- ClinicalTrials.gov ID
- NCT07088003
- Acronym / sponsor ID
- UBuffalo
- Conditions
- Developmental Disability
- Keywords
- Yoga, Mindfulness, Developmental Disability, Children, Early Elementary School
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 28 Jul 2025 (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.
This study aimed to close an existing research gap by exploring the impact of a school-based mindful yoga program, Yoga as Mindful Movement (YMM), on foundational motor skills, social-emotional competence, classroom behavior, attention, and impulse control of students with various developmental disabilities in kindergarten, first-, and second-grade (K-2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga as Mindful Movement | Experimental | Behavioral: Yoga as Mindful Movement |
| Adapted Physical Education | Active comparator | Behavioral: Adapted Physical Education |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Yoga as Mindful MovementYMM is an 8-week hybrid (in-person and virtual) school-based mindful yoga program (modified from its original 10-week, in-person design due to complications of COVID-19) informed by the teachings of Radiant Child Yoga. It was designed to teach students about self regulation through the integration of movement, breath, and present-moment awareness. It was delivered in the form of three, 30-minute YMM sessions each week by the same instructor-an individual with training and experience as an occupational therapist and yoga teacher through the Yoga Alliance and Radiant Child Yoga. | Behavioural | Yoga as Mindful Movement |
| Adapted Physical EducationAdapted PE took place daily (Monday-Friday) for one hour and consisted of lessons on movement skills such as catching, throwing, aiming, running, jumping, skating, and dancing through various activities and games. | Behavioural | Adapted Physical Education |
Primary outcome
Movement Assessment Battery for Children, Second Edition
Time frame: From pre-enrollment (2 weeks before 8-week intervention) to post-enrollment (2 weeks after intervention's conclusion).
The Movement Assessment Battery for Children, Second Edition measures children's motor performance in physical tasks (e.g., threading beads, catching a ball, walking heel-to-toe) through direct observation. Quantifiable criteria (e.g., task completion time, number of successful attempts, number of errors) is measured.
Devereux Student Strengths Assessment-Mini
Time frame: From pre-enrollment (2 weeks before 8-week intervention) to post-enrollment (2 weeks after intervention's conclusion).
This questionnaire asks assessors (classroom instructional staff) to rate how often a student displays certain behaviors (e.g., taking an active role in learning, making a suggestion or request in a polite way) in the past four weeks that correspond to social-emotional, cognitive, and interpersonal skills. Behaviors are rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very Frequently). A higher score indicates more social-emotional competence.
Child Behavior Rating Scale
Time frame: From pre-enrollment (2 weeks before 8-week intervention) to post-enrollment (2 weeks after intervention's conclusion).
The Child Behavior Rating Scale asks classroom instructional staff to indicate how often each student exhibits certain behaviors (e.g., returning to an unfinished task after interruption, attempting new challenging tasks) over the past week. This was completed using a 5-point Likert scale ranging from 1 (Never) to 5 (Always), with a higher score indicating positive behavior.
Head-Toes-Knees-Shoulders-Revised (HTKS-R) modified for Neurodiverse Learners (HTNL)
Time frame: From pre-enrollment (2 weeks before 8-week intervention) to post-enrollment (2 weeks after intervention's conclusion).
1 secondary outcome
Classroom Observations
Time frame: From enrollment to the end of treatment at 8 weeks
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 28 Jul 2025.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared due to concerns about participant privacy and limitations in the informed consent that prevent broader data sharing.
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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.
Catherine P. Cook-Cottone, PhD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga as Mindful Movement and Adapted Physical Education in people with Developmental Disability, run by University at Buffalo at 1 site 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?
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 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Movement Assessment Battery for Children, Second Edition (time frame: From pre-enrollment (2 weeks before 8-week intervention) to post-enrollment (2 weeks after intervention's conclusion).). The study lists 4 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 28 Jul 2025.