Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges (MM)
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|ClinicalTrials.gov Identifier: NCT02766101|
Recruitment Status : Completed
First Posted : May 9, 2016
Last Update Posted : May 9, 2016
|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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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 :||October 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
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.
- Change in Minutes and Number of Disciplinary Time Out of Class Events (classroom functioning) [ Time Frame: 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766101
|United States, Massachusetts|
|Judge Baker Children's Center, Manville School|
|Boston, Massachusetts, United States, 02115|