NCT07088003

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2022

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 11, 2025

Last Update Submit

July 23, 2025

Conditions

Keywords

YogaMindfulnessDevelopmental DisabilityChildrenEarly Elementary School

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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)

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

Secondary Outcomes (1)

  • Classroom Observations

    From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Yoga as Mindful Movement

EXPERIMENTAL
Behavioral: Yoga as Mindful Movement

Adapted Physical Education

ACTIVE COMPARATOR
Behavioral: Adapted Physical Education

Interventions

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.

Yoga as Mindful Movement

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.

Adapted Physical Education

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cantalician Center

Buffalo, New York, 14226, United States

Location

MeSH Terms

Conditions

Developmental Disabilities

Interventions

Yoga

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Catherine P. Cook-Cottone, PhD

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 11, 2025

First Posted

July 28, 2025

Study Start

October 4, 2021

Primary Completion

February 14, 2022

Study Completion

March 2, 2022

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

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.

Locations