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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01305876
Other study ID # 8756
Secondary ID
Status Completed
Phase N/A
First received February 18, 2011
Last updated February 25, 2011
Start date December 2008
Est. completion date June 2009

Study information

Verified date February 2011
Source Tufts Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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.


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)

1. Behavior Assessment Scale for Children (BASC).

2. The Swanson, Kotkin, Agler, M-Flynn & Pelham Rating Scale (SKAMP)


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 12 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
yoga intervention
yoga session 2 x week over 3-1/2 months

Locations

Country Name City State
United States Tufts Medical Center / Tufts University Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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 No
Primary 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). 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. No
Secondary 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). The classroom teachers filled out the SKAMP pre- and post-intervention No