Examining Effects of Holistic School Enrichment Programs

Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05118932
Collaborator
National Center for Advancing Translational Science (NCATS) (NIH)
200
1
1
72.3
2.8

Study Details

Study Description

Brief Summary

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 and emotional control through engagement of mindful movement practice.

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 (1-2 hours) in which they will complete tests of executive and motor functioning. They will also complete a self-report measure of irritability. At these assessment points, parents and teachers will complete rating forms about the children including assessments of emotional, behavioral and attentional regulation.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindful Movement Intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Examining Effects of Holistic School Enrichment Programs
Actual Study Start Date :
May 22, 2017
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mindful Movement Intervention

The Mindful Movement Intervention (MMI) targets improved attentional, behavioral and emotional regulation through engagement of the motor system and mindful practice in school-age children. For this project, children will participate in the MMI twice a week for 45 minutes a session for the duration of the academic year. The intervention will be held during school hours to make it more accessible to all students and require fewer additional resources. Briefly, there are five components that make-up the Mindful Movement Intervention: Biomechanical Warm-ups, Yoga postures, a modified Tai Chi sequence, Imaginative Play, and Reflection. One goal of this intervention is to help children to develop the skills needed to cope with naturally occurring changes and to adapt to their environment in a mindful, non-reactive manner. In this context, students are learning to control and manage their attention, behavior and emotion through implicit procedural learning.

Behavioral: Mindful Movement Intervention
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.

Outcome Measures

Primary Outcome Measures

  1. Evolution of Strengths and Weaknesses of Attention-Deficit/ Hyperactivity-symptoms and Normal-behaviors (SWAN) rating scale score. [9 months]

    The 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).

Secondary Outcome Measures

  1. Evolution of executive functioning skills [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 [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 Outcome Measures

  1. Evolution of motor function [9 months]

    The evolution of motor function will be assessed by the Physical and Neurological Examination for Subtle Signs (PANESS). 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 response inhibition [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).

  3. Evolution of emotion regulation [9 months]

    The evolution of emotion regulation will be assessed by the Emotion Regulation Index for Children and Adolescents (ERICA) questionnaire. The subscale and total score on the ERICA 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Children must be between ages 7 years, 0 months to 15 years, 11 months, 30 days.

Exclusion Criteria (Children will be excluded if they have any of the following, established via review of medical and developmental history):

  • Diagnosis of Intellectual Disability

  • Neurologic disorder (e.g., epilepsy, cerebral palsy, traumatic brain injury, Tourette Syndrome)

  • Diagnosis of conduct dx or exhibiting signs of conduct dx

  • Documented hearing impairment ≥ 25 dB loss in either ear.

  • Significant learning problems (Children will be excluded if they are in special education classrooms exclusively. Children in regular education classroom with supports or pull outs will be included)

  • In foster care

  • Pregnant

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kennedy Krieger Institute Baltimore Maryland United States 21205

Sponsors and Collaborators

  • Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  • National Center for Advancing Translational Science (NCATS)

Investigators

  • Principal Investigator: Stewart Mostofsky, MD, PhD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:
NCT05118932
Other Study ID Numbers:
  • IRB00129138
First Posted:
Nov 12, 2021
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Results

No Results Posted as of Jul 19, 2022