- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02766101
Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges (MM)
May 5, 2016 updated by: Kirsten Davison, Harvard School of Public Health (HSPH)
Can a Physical Activity Program Implemented at a Therapeutic School Promote Emotional Regulation and School Success in Socially and Emotionally Vulnerable Children?
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Judge Baker Children's Center, Manville School
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
Sustained aerobic exercise.
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ACTIVE_COMPARATOR: Standard PE
Traditional PE focused on gross motor skill and sports skill acquisition, and team building.
Typically non-aerobic.
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Non-aerobic skill building.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Assessed Daily for 14 weeks (7 weeks in intervention arm and 7 weeks in control arm)
|
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)
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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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (ACTUAL)
April 1, 2015
Study Completion (ACTUAL)
April 1, 2015
Study Registration Dates
First Submitted
April 25, 2016
First Submitted That Met QC Criteria
May 5, 2016
First Posted (ESTIMATE)
May 9, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
May 9, 2016
Last Update Submitted That Met QC Criteria
May 5, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB14-2312
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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