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Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges (MM)

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ClinicalTrials.gov Identifier: NCT02766101
Recruitment Status : Completed
First Posted : May 9, 2016
Last Update Posted : May 9, 2016
Sponsor:
Collaborator:
Judge Baker Children's Center
Information provided by (Responsible Party):
Kirsten Davison, Harvard School of Public Health

Brief Summary:
The purpose of this study is to examine whether an exergaming, aerobic physical education (PE) curriculum is acceptable and elicits improvements in behavioral self-regulation and classroom functioning among children with behavioral health challenges attending a therapeutic day school. After following an approved consent/assent process, children attending the school were randomized by classroom to take part in either 7 weeks of the experimental PE curriculum, or 7 weeks of the standard PE curriculum; after a 10 week washout period, children then crossed over into the other arm.

Condition or disease Intervention/treatment Phase
Autistic Disorder Attention Deficit and Disruptive Behavior Disorders Anxiety Disorders Mood Disorders Conduct Disorder Oppositional Defiant Disorder Behavioral: Aerobic Exergaming PE Curriculum Behavioral: Standard PE Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Can a Physical Activity Program Implemented at a Therapeutic School Promote Emotional Regulation and School Success in Socially and Emotionally Vulnerable Children?
Study Start Date : October 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aerobic Exergaming PE
Progressive aerobic curriculum utilizing virtual reality exergaming stationary bicycles. Classes held 2 times per week for 30-40 minutes, aerobic exercise beginning at 10 minutes at moderate to vigorous intensity and building to 20 minutes plus.
Behavioral: Aerobic Exergaming PE Curriculum
Sustained aerobic exercise.

Active Comparator: Standard PE
Traditional PE focused on gross motor skill and sports skill acquisition, and team building. Typically non-aerobic.
Behavioral: Standard PE
Non-aerobic skill building.




Primary Outcome Measures :
  1. Change in Minutes and Number of Disciplinary Time Out of Class Events (classroom functioning) [ Time Frame: Assessed Daily for 14 weeks (7 weeks in intervention arm and 7 weeks in control arm) ]
    Recording of student number of times and total minutes per day asked to leave the classroom due to disruptive or aggressive behavior. This outcome measure is recorded at the time of event on a mobile survey platform by the present classroom counselor. The measure may be dichotomized into clinical thresholds of time out of class either disruptive or preclusive of learning. A common measurement of classroom functioning in therapeutic school environments.

  2. Change in Conners Abbreviated Teacher Rating Scale score (behavioral dysregulation: impulsivity/emotional lability) [ Time Frame: Assessed Daily for 14 weeks (7 weeks in intervention arm and 7 weeks in control arm) ]
    Recording of classroom counselor assessment of student impulsivity/hyperactivity and emotional lability using the Conners Abbreviated Teacher Rating Scale 10-item (CATRS-10). CATRS-10 is a commonly used and validated screening instrument for behavioral problems related to inattention, impulsivity/hyperactivity and emotional lability. Classroom counselors completed the CATRS-10 at the end of each school day for each student. The instrument consists of 10 statements regarding the child's behavior rated on a 4-point Likert scale, with a possible total score from 0 to 30. A score of 15 or higher has been the standard for screening children with symptomology at a level of clinical concern.Equivalent screening thresholds were used for the emotional lability subscale (≥6 out of possible 12) and impulsivity subscale (≥9 out of possible 18). Thus this outcome measure can also be dichotomized for analytical and clinical interpretation purposes.



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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Attending the Manville School at the time of study initiation

Exclusion Criteria:

  • Medical exemption from physical education classes
  • Parental opt out from physical education classes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766101


Locations
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United States, Massachusetts
Judge Baker Children's Center, Manville School
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Harvard School of Public Health
Judge Baker Children's Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kirsten Davison, Associate Professor, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT02766101    
Other Study ID Numbers: IRB14-2312
First Posted: May 9, 2016    Key Record Dates
Last Update Posted: May 9, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Mood Disorders
Autistic Disorder
Mental Disorders
Problem Behavior
Conduct Disorder
Attention Deficit and Disruptive Behavior Disorders
Pathologic Processes
Neurodevelopmental Disorders
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Behavioral Symptoms