- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01305876
Yoga in an Urban School for Children With Emotional Behavioral Disorders
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Tufts Medical Center / Tufts University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- identified by the teaching staff or special education director as having an emotional -behavioral disorder
Exclusion Criteria:
- inability to comprehendread in English sufficiently to complete written assessments and follow the yoga interventionintervention protocols
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: one group with yoga intervention
|
yoga session 2 x week over 3-1/2 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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)
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).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Swanson, Kotkin, Agler, M-Flynn & Pelham Rating Scale (SKAMP)
Time Frame: The classroom teachers filled out the SKAMP pre- and post-intervention
|
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).
|
The classroom teachers filled out the SKAMP pre- and post-intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8756
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