Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges
MM
Can a Physical Activity Program Implemented at a Therapeutic School Promote Emotional Regulation and School Success in Socially and Emotionally Vulnerable Children?
1 other identifier
interventional
103
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 25, 2016
CompletedFirst Posted
Study publicly available on registry
May 9, 2016
CompletedMay 9, 2016
May 1, 2016
6 months
April 25, 2016
May 5, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Minutes and Number of Disciplinary Time Out of Class Events (classroom functioning)
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.
Assessed Daily for 14 weeks (7 weeks in intervention arm and 7 weeks in control arm)
Change in Conners Abbreviated Teacher Rating Scale score (behavioral dysregulation: impulsivity/emotional lability)
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.
Assessed Daily for 14 weeks (7 weeks in intervention arm and 7 weeks in control arm)
Study Arms (2)
Aerobic Exergaming PE
EXPERIMENTALProgressive 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.
Standard PE
ACTIVE COMPARATORTraditional PE focused on gross motor skill and sports skill acquisition, and team building. Typically non-aerobic.
Interventions
Eligibility Criteria
You may qualify if:
- Attending the Manville School at the time of study initiation
You may not qualify if:
- Medical exemption from physical education classes
- Parental opt out from physical education classes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Judge Baker Children's Center, Manville School
Boston, Massachusetts, 02115, United States
Related Publications (1)
Davison K, Bowling A, Garcia J, Wood B, Hermesch R, Prince J, Hayes A, Kow R, Newlan S, Slavet J. A cybercycling intervention to improve behavioral regulation and classroom functioning among children with behavioral health disorders: Pragmatic randomized trial design for Manville Moves. Contemp Clin Trials. 2016 Jul;49:40-6. doi: 10.1016/j.cct.2016.05.008. Epub 2016 May 31.
PMID: 27261171DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 25, 2016
First Posted
May 9, 2016
Study Start
October 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
May 9, 2016
Record last verified: 2016-05