ClinicalTrials.gg
CompletedNCT07088003Updated Jul 28, 2025

Yoga as Mindful Movement: A Randomized Controlled Trial

An interventional study of Yoga as Mindful Movement and Adapted Physical Education in Developmental Disability, sponsored by University at Buffalo. Completed at 1 site in United States. Open to participants aged 5 Years to 7 Years. Per ClinicalTrials.gov, last updated 2025-07-28.

Sponsored by University at Buffalo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 9 months after the study started (first participant enrolled Oct 2021, registered Jul 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
5 Years to 7 Years
Sex
All
01

Study 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 kindergarten, first-, and second-grade (K-2).

02

Conditions studied

  • Developmental Disability

Keywords

  • Yoga
  • Mindfulness
  • Developmental Disability
  • Children
  • Early Elementary School
03

In context

Developmental Disabilities

230 studies on the registry are indexed under Developmental Disabilities; 65 are open to participants now.

This study's enrollment of 47 is below the median of 60 across 150 interventional studies indexed under Developmental Disabilities.

Browse Developmental Disabilities studies →

Lead sponsor

University at Buffalo is the lead sponsor of 76 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    Yoga as Mindful Movement

    Behavioral: Yoga as Mindful Movement

  • Active comparator
    Adapted Physical Education

    Behavioral: Adapted Physical Education

Interventions

  • BehavioralYoga as Mindful Movement

    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.

  • BehavioralAdapted Physical Education

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From pre-enrollment (2 weeks before 8-week intervention) to post-enrollment (2 weeks after intervention's conclusion).

  2. 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.

    Time frame: From pre-enrollment (2 weeks before 8-week intervention) to post-enrollment (2 weeks after intervention's conclusion).

  3. 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.

    Time frame: From pre-enrollment (2 weeks before 8-week intervention) to post-enrollment (2 weeks after intervention's conclusion).

  4. 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).

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.

    Time frame: From enrollment to the end of treatment at 8 weeks

07

Study locations

1 site
  • Cantalician Center
    Buffalo, New York 14226, United States
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2021 to primary completion in Feb 2022, 4 months.

Of 96 non-industry interventional studies with no phase under Developmental Disabilities, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 49. This study's 4 months is below that.

Counting every sponsor, half of 97 studies reached it within 22 months; a quarter within 13 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 11, 2025
First posted
Jul 28, 2025
StartActual
Oct 4, 2021
Primary completionActual
Feb 14, 2022
CompletionActual
Mar 2, 2022
Last update
Jul 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07088003
Lead sponsor
University at Buffalo
Responsible party
Catherine Cook-Cottone (Professor, University at Buffalo) — Principal investigator
First posted
Jul 28, 2025
Start date
Oct 4, 2021
Primary completion
Feb 14, 2022
Completion
Mar 2, 2022
Last update
Jul 28, 2025

Study contacts

Catherine P. Cook-Cottone, PhD
principal investigator · University at Buffalo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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