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

Study Overview
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Brief Summary
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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.

Official Title
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Can a Physical Activity Program Implemented at a Therapeutic School Promote Emotional Regulation and School Success in Socially and Emotionally Vulnerable Children?

Conditions
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Autistic Disorder, Attention Deficit and Disruptive Behavior Disorders, Anxiety Disorders, Mood Disorders, Conduct Disorder, Oppositional Defiant Disorder

Intervention / Treatment
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* Behavioral: Aerobic Exergaming PE Curriculum
* Behavioral: Standard PE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic Exergaming PE<br>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<br>* Sustained aerobic exercise.<br>|
| Active Comparator: Standard PE<br>Traditional PE focused on gross motor skill and sports skill acquisition, and team building. Typically non-aerobic. | Behavioral: Standard PE<br>* Non-aerobic skill building.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |