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Completed

NCT Number: NCT05118932

Examining Effects of Holistic School Enrichment Programs

The investigators propose to evaluate the efficacy of a Mindful Movement Intervention (MMI) within the Baltimore City Public School (BCPS) system. The goal is to help at-risk youth improve skills important to attentional, behavioral, motor, and emotional control through engagement of mindful movement practices.

To assess the feasibility and efficacy of the program, standardized assessments will be conducted at three time points: the beginning of the school year at the start of the intervention (early September), at the mid-year point (late January), and prior to the end of the school year (early June). During these assessments, participants will be pulled out of their academic classes for brief sessions (1 hour) in which they will complete assessments of attentional, behavioral, motor, and emotional control. At these assessment points, parents and teachers will complete rating forms about the children including assessments of emotional, behavioral, and attention regulation.

Research participants will have the option to reinforce mindful movement practices using a family-based curriculum, participating in peer mentorship, and supporting the development of community educational materials.

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Key information

Conditions

Mindful Movement Intervention (MMI) Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City Neighbors Charter School, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Students must be between the ages 7 years, 0 months and 15 years, 11 months, 30 days.
  • Students with a diagnosis of depression, anxiety, autism, oppositional defiant disorder, and post traumatic stress disorder can be included in the research study
  • Students taking stimulant medications and all other psychoactive medications can be included in the research study.
  • Students in general education classrooms with supports, aides, and/or pull-outs

Exclusion criteria

  • Diagnosis of...
  • intellectual disability
  • a neurological disorder (e.g., epilepsy, cerebral palsy, traumatic brain injury, Tourette Syndrome)
  • conduct disorder or a recorded history of symptoms consistent with conduct disorder
  • a documented hearing impairment ≥ 25 dB loss in either ear
  • significant learning difficulties that require a special education plan.
  • Students in foster care
  • Students who are or may be pregnant

Treatment and study plan

Mindful Movement Intervention

Behavioral

There are five components that together make-up the Mindful Movement Intervention: Biomechanical Warm-ups, Yoga postures, modified Tai Chi sequence, Imaginative Play, and Reflection. During the year, participants will learn a "Simplified" Form of a classic Tai Chi sequence. Yoga movements will be used to prepare participants for the nuanced movements of Tai Chi practice, with both Yoga and Tai Chi providing a physical framework in which participants can track their own progress and begin to understand how to better regulate their attention, behavior and emotional responses. Imaginative Play and Reflection Activities are used to stimulate a deeper curiosity in participants about the everyday use and employment of mindfulness practice and to engage participants.

Primary outcomes

  1. Dimensional Assessment of the Evolution of Attention-Deficit/Hyperactivity Symptoms

    Time frame: 9 months

    The Strengths and Weaknesses of ADHD-symptoms and Normal-behavior (SWAN) rating scale has been developed to measure children's attention skills as well as emotional and behavioral regulatory control. The seven-point questionnaire ranges from +3 (far below average) to -3 (far above average).

    Parent and teacher versions of the SWAN will be collected for each participant and subscale and total scores on the SWAN will be assessed at the start of the intervention (month 0), midway through the intervention (month 4) and at the end of the intervention (month 9).

  2. Assessment of the Evolution of Attention-Deficit/Hyperactivity Symptoms

    Time frame: 9 months

    The DuPaul rating scale is used to assess ADHD related behaviors over the past six months. The 18-item scale uses a 4-point Likert scale with 0 = Not at all and 3 = Very Often.

    Parent and teacher versions the DuPaul will be collected for each participant and subscale and total scores on the DuPaul will be assessed at the start of the intervention (month 0), midway through the intervention (month 4) and at the end of the intervention (month 9).

Secondary outcomes

  1. Evolution of Executive Functioning Skills

    Time frame: 9 months

    The evolution of executive functioning skills will be assessed with the Delis-Kaplan Executive Function System (DKEFS) Trails.

    The DKEFS number-letter switching score will be assessed at the start of the intervention (month 0), midway through the intervention (month 4) and at the end of the intervention (month 9).

  2. Evolution of Inhibitory Control

    Time frame: 9 months

    The evolution of inhibitory control will be assessed with a Simple Go/No-Go task.

    The commission error rate and reaction time variability on the Go/No-Go task will be assessed at the start of the intervention (month 0), midway through the intervention (month 4) and at the end of the intervention (month 9).

Other outcomes

  1. Evolution of Motor Function

    Time frame: 9 months

    The evolution of motor function will be assessed by the Physical and Neurological Examination for Subtle Signs (PANESS). The 32 item motor exam includes possible scores ranging from 0 to 105, with higher scores indicating worse motor function.

    The total score, overflow movement score, and dysrhythmia score from the PANESS will be assessed at the start of the intervention (month 0), midway through the intervention (month 4) and at the end of the intervention (month 9).

  2. Evolution of Motor Persistence

    Time frame: 9 months

    The evolution of motor persistence will be assessed by the Developmental Neuropsychological Assessment (NEPSY) Statue. During a 75-second time period, children will attempt to ignore sound distractors while maintaining a body position. The total score ranges from 0 to 30 with higher scores indicating better performance.

    The total score from the NEPSY statue will be assessed at the start of the intervention (month 0), midway through the intervention (month 4) and at the end of the intervention (month 9).

  3. Evolution of Motor Control

    Time frame: 9 months

    The evolution of motor control will be assessed by the Lateral Gaze Fixation. Students will be timed until 30 seconds with longer times indicating better performance.

    The total time from the Lateral gaze fixation will be assessed at the start of the intervention (month 0), midway through the intervention (month 4) and at the end of the intervention (month 9).

  4. Evolution of Response Inhibition

    Time frame: 9 months

    The evolution of response inhibition will be assessed with administration of the flanker task.

    Incongruent error rate and reaction time variability from the flanker task will be assessed at the start of the intervention (month 0), midway through the intervention (month 4) and at the end of the intervention (month 9).

  5. Evolution of Child-Reported Emotion Regulation

    Time frame: 9 months

    The evolution of child-reported emotion regulation will be assessed by the Social Emotional Assets and Resilience Scales Child-Report (SEARS-C) short form questionnaire. This questionnaire is a 12-item scale that uses a 4-point Likert scale with 0= Never and 3-Always.

    The subscale and total score on the SEARS-C questionnaire will be assessed at the start of the intervention (month 0), midway through the intervention (month 4) and at the end of the intervention (month 9).

  6. Evolution of Caregiver-Reported Emotion Regulation

    Time frame: 9 months

    The evolution of caregiver-reported emotion regulation will be assessed by the Social Emotional Assets and Resilience Scales (SEARS). This questionnaire is a 35-item scale that uses a 4-point Likert scale with 0= Never and 3-Always.

    The subscale and total score on the SEARS questionnaire will be assessed at the start of the intervention (month 0), midway through the intervention (month 4) and at the end of the intervention (month 9).

  7. Assessment of Caregiver-Family Quality of Life

    Time frame: 9 months

    The assessment of family quality of life will be measured by the Family Quality of Life Scale (FQOL Scale). This questionnaire is a 25-item scale that uses a 5-point Likert scale with 1= Very dissatisfied, 3= Neither satisfied nor dissatisfied, and 5= Very satisfied.

    The subscale and total score on the FQOL questionnaire will be assessed at the start of the intervention (month 0) and at the end of the intervention (month 9).

  8. Evolution of Child-Reported Impulsivity and Risk-Taking Behavior

    Time frame: 9 months

    The evolution of child-reported impulsivity and risk-taking behavior will be assessed by the UPPS (urgency, premeditation, perseverance, and sensation seeking) Impulsivity Scale, child version. This questionnaire is a 40-item scale that uses a 4-point Likert scale with 1=strongly disagree to 4=strongly agree.

    The subscale and total score on the UPPS questionnaire will be assessed at the start of the intervention (month 0), midway through the intervention (month 4), and at the end of the intervention (month 9).

  9. Evolution of Child-Reported Tolerance to Uncertainty

    Time frame: 9 months

    The evolution of child-reported tolerance to uncertainty will be assessed by the intolerance of uncertainty scale for children (IUSC). This questionnaire is a 27-item scale that uses a 5-point Likert scale with 1=not at all, 3= somewhat, 5= very much.

    The subscale and total score on the IUSC questionnaire will be assessed at the start of the intervention (month 0), midway through the intervention (month 4), and at the end of the intervention (month 9).

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Nov 12, 2021
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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