Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Persistent poor outcomes for individuals with ADHD make it imperative to explore intervention approaches beyond medication, particularly interventions that could provide sustained improvements in control of hyperactive, impulsive and distractible behavior. Two lines of evidence converge to support a movement-based mindfulness training intervention as a potential stand-alone or adjunct treatment for the treatment of ADHD symptoms. First, decades of research, including from the CNIR, has established that many children with ADHD show impairments in motor control that parallel impairments in behavioral and cognitive control. Second, there is mounting evidence that movement-based mindfulness interventions are effective for enhancing behavioral control in adults, although there has been limited examination in children. Pediatric applications of mindful movement training remain under-utilized and under-investigated. Critically, there is currently no solid evidence regarding the long-term effects of mindfulness-based approaches for children with developmental challenges. By engaging in extended practice, the investigators expect to effect more readily quantified changes in motor system targets that mediate changes in cognitive ADHD symptoms. These lines of evidence suggest an outstanding opportunity for development of long-term novel treatment approaches for ADHD through engagement of the motor system. In this application the investigators propose to examine the efficacy of a specific movement-based mindfulness intervention for children with ADHD - Tai Chi. This approach was chosen for a number of reasons: 1) extensive documentation in the research literature, 2) engagement afforded by a martial approach to mindful movement, and 3) scalability given the existing availability of Tai Chi instruction in the United States and the ease of performing gentle Tai Chi movements even in the presence of physical limitation. The CNIR has evaluated the impact of Tai Chi training on specific motor behavioral (e.g., motor overflow, motor impersistence) and physiologic (TMS assessment of SICI) measures, as well as direct measures of clinical severity. Interestingly, while robust changes in ADHD symptoms have been observed, motor system targets have proven more challenging to characterize via laboratory methods in spite of obvious development of proficiency in tai chi movement skills. The investigators will therefore engage in a follow-on intervention of greater duration that may help elucidate changes that were difficult to detect following an initial 8-week tai chi intervention. By extending the intervention, markers useful in targeting and monitoring intervention may be better identified, with the overarching long-term goal of optimal use of Tai Chi and other movement-based approaches to help children with ADHD gain increased control of impulsive, hyperactive, and distractible behavior. The results of this investigation will lay the groundwork for future clinical trials evaluating movement training as an effective intervention for ADHD that could bolster (supplement) or even replace current standard treatments. Overview of intervention Tai Chi is a form of exercise with a variety of components and a strong cultural tradition. In consultation with experienced teachers of Tai Chi, the investigators have received consistent feedback that "martial applications," and specifically push hands, will likely be a valuable component of training for children with high distractibility. Central to the martial practice of Tai Chi is a collaborative game called "Push Hands," in which partners attempt to push one another off balance without the use of strong effort. Push hands, and other Tai Chi inspired "games" will be used to motivate engagement in slower, more focused movement training: Tai Chi warm-up, postural and breathing exercises, and a section of a Tai Chi form. These components are expected to collectively drive learning and development of behavioral control in the motor domain, with high potential for impact on other features of ADHD. The mindful movement instructors have extensive experience with youth instruction, as well as a keen understanding of the relationships between Tai Chi and other mindful movement practices (i.e. yoga). An assistant instructor will additionally be engaged to assist with maintaining class focus. All instructors will be certified for ethical treatment of human subjects, as well as standards for youth physical education. Sessions will be held in an athletic facility on the Kennedy Krieger Institute (KKI) Greenspring campus. The athletic facility was designed and equipped for children with a range of abilities as part of the LEAP Program (Life-skills and Education for Students with Autism and other Pervasive Behavioral Challenges). It is advantageously located on a campus that is very convenient for most Baltimore area families. The facility moreover has a high-impact floating rubber floor. This environmentally friendly and slip-resistant flooring provides cushioning, which reduces fatigue and potential for injury to the participants during physical activities. Recruitment and testing Participants will be recruited on a continuous and ongoing basis. During the intervention training, children will participate in the movement-based Tai Chi training for one hour twice a week. Up to ten students will participate per class. Students' families will be allowed to participate in the Tai Chi training & will therefore cap the total amount of people at each class at 20. It is expected that some students will be unable to successfully complete the study. Enrollment procedures will be adapted if necessary. As per the "intent to treat" approach, children will be included in primary analyses irrespective of adherence to protocol (i.e., attendance). However, children may be requested to leave the class if their absence becomes disruptive. Pre-intervention data collection will occur at the start of participation in the intervention. Further data collection will continue on a rolling basis with expected data collection every six months following at a Kennedy Krieger Institute facility. In total, it is anticipated that 50 participants complete the training and data collection. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03434509
Study type Interventional
Source Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date November 2, 2017
Completion date December 2024

See also
  Status Clinical Trial Phase
Completed NCT03148782 - Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase N/A
Recruiting NCT06038942 - Formal Versus Informal Mindfulness Among University Students With Self-reported ADHD, Nonsuicidal Self-injury, or Stress N/A
Completed NCT05518435 - Managing Young People With ADHD in Primary Care Study
Active, not recruiting NCT04978792 - Does Cultivating Self-compassion Improve Resilience to Criticism and Improve Mental Health in Adults With ADHD? N/A
Completed NCT03216512 - Effects of Noise Cancelling Headphones on Neurocognitive and Academic Outcomes in ADHD N/A
Completed NCT02900144 - Modified Comprehensive Behavioral Intervention for Tics (M_CBIT) N/A
Not yet recruiting NCT02906501 - Effect of Risperidone on Cognitive Functions in Adolescents With ADHD and Behavioral Disturbances N/A
Completed NCT02829528 - Little Flower Yoga for Kids: Evaluation of a Yoga and Mindfulness Program for Children With Increased Levels of Emotion Dysregulation and Inattention N/A
Completed NCT02562469 - ACTIVATE: A Computerized Training Program for Children With ADHD N/A
Terminated NCT02271880 - Improving Medication Adherence in ADHD Adolescents N/A
Recruiting NCT02255565 - Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study Phase 4
Completed NCT02463396 - Mindfulness Training in Adults With ADHD N/A
Terminated NCT01733680 - Amiloride Hydrochloride as an Effective Treatment for ADHD Early Phase 1
Completed NCT01673594 - Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist Phase 4
Completed NCT02300597 - Internet-based Support for Young People With ADHD and Autism - a Controlled Study N/A
Active, not recruiting NCT01137318 - Combined Cognitive Remediation and Behavioral Intervention for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD) Phase 2
Completed NCT01404273 - Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder N/A
Completed NCT00573859 - The Reinforcing Mechanisms of Smoking in Adult ADHD Phase 1/Phase 2
Completed NCT00586157 - Study of Medication Patch to Treat Children Ages 6-12 With ADHD Phase 4
Completed NCT00228540 - Study to Assess Satisfaction With Modafinil Treatment in Children and Adolescents With ADHD Phase 3