Emotional Behavioral DisordersNCT01305876
Yoga in an Urban School for Children With Emotional Behavioral Disorders
A study testing yoga intervention in people with Emotional Behavioral Disorders, run by Tufts Medical Center at 1 site in United States.
Trial summary
Yoga is becoming a part of therapies for children with emotional behavioral disorders. The goal is to examine the feasibility and efficacy of yoga sessions for children with emotional behavioral disorders at an urban elementary school. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Emotional Behavioral Disorders
- What is being tested?
- yoga intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jun 2009
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- identified by the teaching staff or special education director as having an emotional -behavioral disorder
Who cannot join
- inability to comprehendread in English sufficiently to complete written assessments and follow the yoga interventionintervention protocols
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts Medical Center / Tufts University
Boston, Massachusetts, 02111
About this study
Yoga is becoming a part of therapies for children with emotional behavioral disorders. The goal is to examine the feasibility and efficacy of yoga sessions for children with emotional behavioral disorders at an urban elementary school.
Read the detailed description
Participants: children in 4th and 5th grade at an urban elementary school, identified by the special education director and the teaching staff, as having emotional behavioral disorders including anxiety, depression, aggression, conduct disorder, hyperactivity and attention difficulties. These grades have a combined student population of 160 students. Enrolled over two years.
Inclusion/Exclusion criteria:
Eligible if identified by the teaching staff or special education director as having an emotional behavioral disorder. Exclusion criteria: inability to comprehend English sufficiently to complete written assessments and follow the yoga intervention.
Pre- and post-intervention assessments (teachers)
- Behavior Assessment Scale for Children (BASC).
- The Swanson, Kotkin, Agler, M-Flynn \& Pelham Rating Scale (SKAMP)
- Conditions
- Emotional Behavioral Disorders
- Being tested
- yoga intervention
- Keywords
- yoga, emotional behavioral disorder, intervention, school, meditation, focus: yoga intervention in students with emotional behavioral disorders in an urban school
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yoga interventionBehavioural
yoga session 2 x week over 3-1/2 months
| Study group | Role | What they receive |
|---|---|---|
| one group with yoga intervention | Experimental | one group with yoga intervention Receives: Behavioral: yoga intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior Assessment Scale for Children (BASC).
The BASC was chosen to track the effect of the yoga intervention on classroom behavior. The BASC is a tool tht is frequently used within the school setting to track classroom behavior and overall wellbeing of students. The BASC has been shown to have adequate reliability and validity based on concurrence with similar scales (Reynolds \& Kamphaus, 1992). Subscales include anxiety, aggression, attention problems, hyperactivity, conduct problems, depression, withdrawal and social skills.
Measured: 1 year. The classroom teachers filled out the BASC pre- and post-intervention on each participant. This took place June 2009, after the yoga intervention took place. Has been completed
The Swanson, Kotkin, Agler, M-Flynn & Pelham Rating Scale (SKAMP)
The SKAMP was used for teachers to assess classroom attention. The SKAMP is a validated teacher observation assessment rating scale composed of 10 items, designed to describe classroom behavior and attention (Gansle et al., 2004; Sharon, Wigal, \& Wigal, 2006).The SKAMP is used to monitor interventions and has been shown to be sensitive to change (McBurnett, Swanson, Pfiffner, \& Tam, 1997).
Measured: One year. The teachers filled out the SKAMP pre- and post-intervetnion to assess participants focus in class. This took place June 2009, after the yoga interveniton. Has been completed.
Secondary outcomes (1)
The Swanson, Kotkin, Agler, M-Flynn & Pelham Rating Scale (SKAMP)
The SKAMP was filled out by classroom teachers to assess students' ability to pay attention in class. It is a validated teacher observation assessment rating scale composed of 10 items, designed to describe classroom behavior and attention (Gansle et al., 2004; Sharon, Wigal, \& Wigal, 2006).The SKAMP is used to monitor interventions and has been shown to be sensitive to change (McBurnett, Swanson, Pfiffner, \& Tam, 1997).
Measured: The classroom teachers filled out the SKAMP pre- and post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional Behavioral DisordersStudies 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
- Not applicable
- Intervention model
- Single group
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305876
- Sponsor's protocol ID
- 8756
- Status last verified
- Feb 2011
- First submitted
- 18 Feb 2011
- Last updated
- 1 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga in an Urban School for Children With Emotional Behavioral Disorders
- ClinicalTrials.gov ID
- NCT01305876
- Acronym / sponsor ID
- 8756
- Conditions
- Emotional Behavioral Disorders
- Keywords
- yoga, emotional behavioral disorder, intervention, school, meditation, focus: yoga intervention in students with emotional behavioral disorders in an urban school
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 1 Mar 2011 (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.
Yoga is becoming a part of therapies for children with emotional behavioral disorders. The goal is to examine the feasibility and efficacy of yoga sessions for children with emotional behavioral disorders at an urban elementary school.
Detailed description
Participants: children in 4th and 5th grade at an urban elementary school, identified by the special education director and the teaching staff, as having emotional behavioral disorders including anxiety, depression, aggression, conduct disorder, hyperactivity and attention difficulties. These grades have a combined student population of 160 students. Enrolled over two years.
Inclusion/Exclusion criteria:
Eligible if identified by the teaching staff or special education director as having an emotional behavioral disorder. Exclusion criteria: inability to comprehend English sufficiently to complete written assessments and follow the yoga intervention.
Pre- and post-intervention assessments (teachers)
- Behavior Assessment Scale for Children (BASC).
- The Swanson, Kotkin, Agler, M-Flynn \& Pelham Rating Scale (SKAMP)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group with yoga intervention | Experimental | Behavioral: yoga interventionone group with yoga intervention |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- identified by the teaching staff or special education director as having an emotional -behavioral disorder
Key exclusion criteria (1 listed)
- inability to comprehendread in English sufficiently to complete written assessments and follow the yoga interventionintervention protocols
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 |
|---|---|---|
| yoga interventionyoga session 2 x week over 3-1/2 months | Behavioural | one group with yoga intervention |
Primary outcome
Behavior Assessment Scale for Children (BASC).
Time frame: 1 year. The classroom teachers filled out the BASC pre- and post-intervention on each participant. This took place June 2009, after the yoga intervention took place. Has been completed
The BASC was chosen to track the effect of the yoga intervention on classroom behavior. The BASC is a tool tht is frequently used within the school setting to track classroom behavior and overall wellbeing of students. The BASC has been shown to have adequate reliability and validity based on concurrence with similar scales (Reynolds \& Kamphaus, 1992). Subscales include anxiety, aggression, attention problems, hyperactivity, conduct problems, depression, withdrawal and social skills.
The Swanson, Kotkin, Agler, M-Flynn & Pelham Rating Scale (SKAMP)
Time frame: One year. The teachers filled out the SKAMP pre- and post-intervetnion to assess participants focus in class. This took place June 2009, after the yoga interveniton. Has been completed.
The SKAMP was used for teachers to assess classroom attention. The SKAMP is a validated teacher observation assessment rating scale composed of 10 items, designed to describe classroom behavior and attention (Gansle et al., 2004; Sharon, Wigal, \& Wigal, 2006).The SKAMP is used to monitor interventions and has been shown to be sensitive to change (McBurnett, Swanson, Pfiffner, \& Tam, 1997).
1 secondary outcome
The Swanson, Kotkin, Agler, M-Flynn & Pelham Rating Scale (SKAMP)
Time frame: The classroom teachers filled out the SKAMP pre- and post-intervention
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 1 Mar 2011.
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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 yoga intervention in people with Emotional Behavioral Disorders, run by Tufts Medical Center 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 1 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 1 Mar 2011. 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?
Behavior Assessment Scale for Children (BASC). (time frame: 1 year. The classroom teachers filled out the BASC pre- and post-intervention on each participant. This took place June 2009, after the yoga intervention took place. Has been completed). 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?
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 1 Mar 2011.