Clinical trial NCT05118932: Examining Effects of Holistic School Enrichment Programs
Official title: Examining Effects of Holistic School Enrichment Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindful Movement Intervention (MMI)
Keywords: Mindfulness
Attention Deficit Hyperactivity Disorder (ADHD)
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2021-11-12
Enrollment: 196
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All students will be receiving the same single intervention.
Primary purpose: TREATMENT

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, 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. Students in foster care
3. Students who are or may be pregnant

Primary outcomes:
measure: Dimensional Assessment of the Evolution of Attention-Deficit/Hyperactivity Symptoms
timeFrame: 9 months
measure: Assessment of the Evolution of Attention-Deficit/Hyperactivity Symptoms
timeFrame: 9 months
Secondary outcomes:
measure: Evolution of Executive Functioning Skills
timeFrame: 9 months
measure: Evolution of Inhibitory Control
timeFrame: 9 months
Other outcomes:
measure: Evolution of Motor Function
timeFrame: 9 months
measure: Evolution of Motor Persistence
timeFrame: 9 months
measure: Evolution of Motor Control
timeFrame: 9 months
measure: Evolution of Response Inhibition
timeFrame: 9 months
measure: Evolution of Child-Reported Emotion Regulation
timeFrame: 9 months
measure: Evolution of Caregiver-Reported Emotion Regulation
timeFrame: 9 months
measure: Assessment of Caregiver-Family Quality of Life
timeFrame: 9 months
measure: Evolution of Child-Reported Impulsivity and Risk-Taking Behavior
timeFrame: 9 months
measure: Evolution of Child-Reported Tolerance to Uncertainty
timeFrame: 9 months
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
city: Baltimore
country: United States
facility: City Neighbors Charter School
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Stewart Mostofsky, MD
role: PRINCIPAL_INVESTIGATOR
References: