Examining Effects of Holistic School Enrichment Programs

Not Applicable

• Conditions: Mindful Movement Intervention (MMI)

• Registration Number: NCT05118932
• Lead Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-22
• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-12
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-03
• Primary Completion: 2024-06
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Assessment of the Evolution of Attention-Deficit/Hyperactivity Symptoms	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).
Dimensional Assessment of the Evolution of Attention-Deficit/Hyperactivity Symptoms	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).

Secondary Outcome Measures

Name	Time	Method
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).
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).

Trial Locations

Locations (2)

Kennedy Krieger Institute; 🇺🇸 Baltimore, Maryland, United States

City Neighbors Charter School; 🇺🇸 Baltimore, Maryland, United States