NCT01305876

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 1, 2011

Completed
Last Updated

March 1, 2011

Status Verified

February 1, 2011

Enrollment Period

6 months

First QC Date

February 18, 2011

Last Update Submit

February 25, 2011

Conditions

Keywords

yogaemotional behavioral disorderinterventionschoolmeditationfocus: yoga intervention in students with emotional behavioral disorders in an urban school

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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.

Secondary Outcomes (1)

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

    The classroom teachers filled out the SKAMP pre- and post-intervention

Study Arms (1)

one group with yoga intervention

EXPERIMENTAL

one group with yoga intervention

Behavioral: yoga intervention

Interventions

yoga session 2 x week over 3-1/2 months

one group with yoga intervention

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • identified by the teaching staff or special education director as having an emotional -behavioral disorder

You may not qualify if:

  • inability to comprehendread in English sufficiently to complete written assessments and follow the yoga interventionintervention protocols

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts Medical Center / Tufts University

Boston, Massachusetts, 02111, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 18, 2011

First Posted

March 1, 2011

Study Start

December 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

March 1, 2011

Record last verified: 2011-02

Locations