Autistic DisorderMMNCT02766101
Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges
A study testing Aerobic Exergaming PE Curriculum and Standard PE in people with Autistic Disorder and Attention Deficit and Disruptive Behavior Disorders, run by Harvard School of Public Health (HSPH) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Autistic Disorder, Attention Deficit and Disruptive Behavior Disorders, Anxiety Disorders
- What is being tested?
- Aerobic Exergaming PE Curriculum and Standard PE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Attending the Manville School at the time of study initiation
Who cannot join
- Medical exemption from physical education classes
- Parental opt out from physical education classes
Trial locations and contacts
1 site in 1 country.
United States1 site
Judge Baker Children's Center, Manville School
Boston, Massachusetts, 02115
About this study
Official title: 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.
- Conditions
- Autistic Disorder, Attention Deficit and Disruptive Behavior Disorders, Anxiety Disorders, Mood Disorders, Conduct Disorder, Oppositional Defiant Disorder
- Being tested
- Aerobic Exergaming PE Curriculum, Standard PE
- Medical subject headings
- Autistic Disorder, Attention Deficit and Disruptive Behavior Disorders, Anxiety Disorders, Mood Disorders, Conduct Disorder, Oppositional Defiant Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exergaming PE CurriculumBehavioural
Sustained aerobic exercise.
Standard PEBehavioural
Non-aerobic skill building.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exergaming PE | Experimental | 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. Receives: Behavioral: Aerobic Exergaming PE Curriculum |
| Standard PE | Active comparator | Traditional PE focused on gross motor skill and sports skill acquisition, and team building. Typically non-aerobic. Receives: Behavioral: Standard PE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Assessed Daily for 14 weeks (7 weeks in intervention arm and 7 weeks in control arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startOct 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Judge Baker Children's Center
- Responsible party
- Principal investigator, Kirsten Davison, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766101
- Sponsor's protocol ID
- IRB14-2312
- Acronym
- MM
- Status last verified
- May 2016
- First submitted
- 25 Apr 2016
- Last updated
- 9 May 2016
- Results posted
- No
Publications
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.
PubMed 27261171
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Physical Activity Program Implemented at a Therapeutic School Promote Emotional Regulation and School Success in Socially and Emotionally Vulnerable Children?
- ClinicalTrials.gov ID
- NCT02766101
- Acronym / sponsor ID
- MM / IRB14-2312
- Conditions
- Autistic Disorder, Attention Deficit and Disruptive Behavior Disorders, Anxiety Disorders, Mood Disorders, Conduct Disorder, Oppositional Defiant Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Judge Baker Children's Center
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exergaming PE | Experimental | Behavioral: Aerobic Exergaming PE CurriculumProgressive 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. |
| Standard PE | Active comparator | Behavioral: Standard PETraditional PE focused on gross motor skill and sports skill acquisition, and team building. Typically non-aerobic. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Attending the Manville School at the time of study initiation
Key exclusion criteria (2 listed)
- Medical exemption from physical education classes
- Parental opt out from physical education classes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exergaming PE CurriculumSustained aerobic exercise. | Behavioural | Aerobic Exergaming PE |
| Standard PENon-aerobic skill building. | Behavioural | Standard PE |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- Derived from this study: PubMed 27261171Davison 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exergaming PE Curriculum and Standard PE in people with Autistic Disorder and Attention Deficit and Disruptive Behavior Disorders, run by Harvard School of Public Health (HSPH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02766101, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.