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

Anxiety Disorders Clinical Trial

— MM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02766101
• Other study ID #: IRB14-2312
• Status: Completed
• Phase: N/A
• First received: April 25, 2016
• Last updated: May 5, 2016
• Start date: October 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2016
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Attention Deficit and Disruptive Behavior Disorders
• Attention Deficit Disorder with Hyperactivity
• Autistic Disorder
• Conduct Disorder
• Disease
• Mood Disorders
• Oppositional Defiant Disorder

Intervention

Behavioral:
• Aerobic Exergaming PE Curriculum
Sustained aerobic exercise.
• Standard PE
Non-aerobic skill building.

Locations

Country	Name	City	State
United States	Judge Baker Children's Center, Manville School	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Judge Baker Children's Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No