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

Primary Purpose

Autistic Disorder, Attention Deficit and Disruptive Behavior Disorders, Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exergaming PE Curriculum
Standard PE
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Disorder

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Judge Baker Children's Center, Manville School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic Exergaming PE

Standard PE

Arm Description

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.

Traditional PE focused on gross motor skill and sports skill acquisition, and team building. Typically non-aerobic.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 25, 2016
Last Updated
May 5, 2016
Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Judge Baker Children's Center
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1. Study Identification

Unique Protocol Identification Number
NCT02766101
Brief Title
Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges
Acronym
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?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Judge Baker Children's Center

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder, Attention Deficit and Disruptive Behavior Disorders, Anxiety Disorders, Mood Disorders, Conduct Disorder, Oppositional Defiant Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exergaming PE
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard PE
Arm Type
Active Comparator
Arm Description
Traditional PE focused on gross motor skill and sports skill acquisition, and team building. Typically non-aerobic.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exergaming PE Curriculum
Intervention Description
Sustained aerobic exercise.
Intervention Type
Behavioral
Intervention Name(s)
Standard PE
Intervention Description
Non-aerobic skill building.
Primary Outcome Measure Information:
Title
Change in Minutes and Number of Disciplinary Time Out of Class Events (classroom functioning)
Description
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.
Time Frame
Assessed Daily for 14 weeks (7 weeks in intervention arm and 7 weeks in control arm)
Title
Change in Conners Abbreviated Teacher Rating Scale score (behavioral dysregulation: impulsivity/emotional lability)
Description
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.
Time Frame
Assessed Daily for 14 weeks (7 weeks in intervention arm and 7 weeks in control arm)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Judge Baker Children's Center, Manville School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27261171
Citation
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.
Results Reference
derived

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

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