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

Sponsor

Harvard School of Public Health (HSPH) (Other)

Overall Status

Completed

CT.gov ID

NCT02766101

Collaborator

Judge Baker Children's Center (Other)

103

Enrollment

Location

Arms

Duration (Months)

17.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Oct 1, 2014

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.