NCT03434509

Brief Summary

Attention Deficit Hyperactivity Disorder (ADHD) has tremendous individual and societal impact, and the effectiveness of current standard treatments is limited. Thus, there are potential public health benefits for novel behavioral training programs that could remediate the core features of ADHD and contribute to sustained improvements in behavioral control. There is mounting evidence that children with ADHD show difficulties with motor control, and that these motor deficits are strongly associated with the core behavioral features of ADHD. Based on this information, the CNIR initiated a feasibility trial of a movement-based intervention, utilizing Tai Chi practice, targeting improved behavioral control through engagement of the motor system and results are highly promising. The investigators therefore will employ an extension of our ongoing Tai Chi programs for children with ADHD, beginning with children who have already completed one of the previous Tai Chi sessions. This program will provide the basis for studying the long-term effects of mindful movement, as well as creating a foundation for exploring the way that such interventions can be expanded into a more realistic support setting for the community. Hypothesis: After participating in the ongoing Tai Chi program, children with ADHD will show improvements in behavioral measures of motor, cognitive, and attentional control. The investigators further expect movement-based training will result in decreases in ADHD symptom severity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2017

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2026

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

6.2 years

First QC Date

November 27, 2017

Last Update Submit

February 26, 2026

Conditions

Keywords

Motor ControlAttentionCognitive Control

Outcome Measures

Primary Outcomes (10)

  • Cognitive Motor Control: Response inhibition

    RDoC (research domain criteria) battery for cognitive control targeting response inhibition delivered via laboratory computer (Go/No-Go) examining percentage of error rate and successful inhibition. Significant improvements in response inhibition are expected over the course of the intervention.

    From date of baseline and at every 6 months following, assessed up to 60 months.

  • Cognitive Motor Control: Response inhibition

    RDoC (research domain criteria) battery for cognitive control targeting response inhibition delivered via laboratory computer (Flanker) examining percentage of error rate and successful inhibition. Significant improvements in response inhibition are expected over the course of the intervention.

    From date of baseline and at every 6 months following, assessed up to 60 months.

  • Cognitive Motor Control: Response inhibition

    RDoC (research domain criteria) battery for cognitive control targeting response inhibition delivered via laboratory computer (Stop-Signal) examining percentage of error rate and successful inhibition. Significant improvements in response inhibition are expected over the course of the intervention.

    From date of baseline and at every 6 months following, assessed up to 60 months.

  • Cognitive Motor Control: Response inhibition

    RDoC (research domain criteria) battery for cognitive control targeting response inhibition delivered via laboratory computer (Mirror Tracing Persistence Task) examining percentage of error rate and successful inhibition. Significant improvements in response inhibition are expected over the course of the intervention.

    From date of baseline and at every 6 months following, assessed up to 60 months.

  • Cognitive Motor Control: Response inhibition

    RDoC (research domain criteria) battery for cognitive control targeting response inhibition delivered via laboratory computer (DKEFS Trail Making Task) examining percentage of error rate and successful inhibition. Significant improvements in response inhibition are expected over the course of the intervention.

    From date of baseline and at every 6 months following, assessed up to 60 months.

  • Behavioral Assessment of Motor Persistence

    Measure of oculomotor persistence and inhibition using the Lateral Gaze Fixation task. Improvements in oculomotor persistence are expected over the course of the intervention.

    From date of baseline and at every 6 months following, assessed up to 60 months.

  • Behavioral Assessment of Motor Persistence

    Measure of motor persistence and inhibition using the NEPSY Statue Task ("A Developmental NEuroPSYchological Assessment"). Improvements in motor persistence are expected over the course of the intervention.

    From date of baseline and at every 6 months following, assessed up to 60 months.

  • Behavioral Assessments of Motor Overflow

    Measure of motor overflow from the PANESS (Physical and Neurologic Examination of Subtle Signs). Improvements in motor overflow are expected over the course of the intervention.

    From date of baseline and at every 6 months following, assessed up to 60 months.

  • Behavioral Assessments of Basic Motor Control

    Measure of motor control from the mABC-2 (Movement Assessment Battery for Children). Improvements in motor control are expected over the course of the intervention.

    From date of baseline and at every 6 months following, assessed up to 60 months.

  • Clinical Measure of ADHD Symptom Severity

    The Conners-3 survey (parent and teacher). Improvements on this measure are expected over the course of the intervention. In particular, based on previous findings from the CNIR initiated mindful movement feasibility study, marked improvements on Connors-3 subscales for Inattentiveness and Hyperactivity are expected.

    From date of baseline and at every 6 months following, assessed up to 60 months.

Secondary Outcomes (2)

  • Clinical Measure of Mindfulness

    From date of baseline and at every 6 months following, assessed up to 60 months.

  • Clinical Measure of Quality of Life

    From date of baseline and at every 6 months following, assessed up to 60 months.

Study Arms (1)

Tai Chi

EXPERIMENTAL

Ongoing, continuous Tai Chi and mindful movement instruction, 1 hour, twice per week

Other: Continuous Tai Chi and Mindful Movement classes

Interventions

Participants will be enrolled in ongoing Tai Chi and mindful movement classes throughout the year, for 1 hour twice a week. Class sessions will consist of warm up (yoga- and mindfulness-based practices), postural and breathing exercises, Tai Chi form practice, and Tai Chi games (including push hands). Children on stimulant medications will remain on these medications during the training period (though they will be asked to stop medications one day prior to motor and cognitive testing).

Also known as: tai chi, taichi, tai ji, taiji, t'ai chi, t'ai ji
Tai Chi

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children must meet diagnostic criteria for ADHD, based on information from previous participation in "Movement-Based Mindfulness Training for Children with ADHD: A Feasibility Study." Additionally, children must meet criteria on the parent and teacher Conners-3
  • Comorbid oppositional defiant disorder (ODD) and anxiety disorders are permitted
  • Stimulants, psychoactive medications, or no medication are allowed

You may not qualify if:

  • diagnosis of Intellectual Disability, Developmental Language Disorder, Reading Disability, or Autism (screened for using the Social Competence Questionnaire (SCQ)
  • neurologic disorder (e.g., epilepsy, cerebral palsy, traumatic brain injury, Tourette Syndrome)
  • documented hearing impairment ≥ 25 dB (decibel) loss in either ear.
  • a Full Scale IQ (Intelligence Quotient) score on the WISC-IV (Wechsler Intelligence Scale for Children) below 80
  • a standard score below 85 on the Word Reading Subtest, regardless of IQ score
  • foster care
  • Female participants will be excluded if they are pregnant or may be pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LEAP Facility at Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Stewart Mostofsky, MD

    Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2017

First Posted

February 15, 2018

Study Start

November 2, 2017

Primary Completion

December 31, 2023

Study Completion

February 26, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Locations