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

Not Applicable

Completed

• Conditions: Autistic Disorder; Anxiety Disorders; Mood Disorders; Attention Deficit and Disruptive Behavior Disorders; Oppositional Defiant Disorder; Conduct Disorder

• Registration Number: NCT02766101
• Lead Sponsor: Harvard School of Public Health (HSPH)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Study First Submitted: 2016-04-25
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-05
• Last Update Submitted: 2016-05-05
• Study First Posted: 2016-05-09
• Last Update Posted: 2016-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in Minutes and Number of Disciplinary Time Out of Class Events (classroom functioning)	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.
Change in Conners Abbreviated Teacher Rating Scale score (behavioral dysregulation: impulsivity/emotional lability)	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.

Trial Locations

Locations (1)

Judge Baker Children's Center, Manville School; 🇺🇸 Boston, Massachusetts, United States