Status:
COMPLETED
Yoga Based Psychotherapy Group Feasibility and Efficacy Study
Lead Sponsor:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborating Sponsors:
Substance Abuse and Mental Health Services Administration (SAMHSA)
Conditions:
Emotional Lability
PTSD
Eligibility:
All Genders
8-12 years
Phase:
EARLY_PHASE1
Brief Summary
This preliminary study will examine the feasibility of conducting a randomized clinical trial of Yoga Based Psychotherapy (YBPG) and standard care mental health (SCMH) treatment compared to SCMH for c...
Detailed Description
One hundred fifty children (ages 8-12 years) treated at the Center for Child and Family Traumatic Stress (CCTFS) for at least 3 months and their caregivers (total n=300 individuals) will be eligible t...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Children, ages 8-12 years,
- enrolled in treatment at KKFC and their caregivers will be invited to participate if the child continues to exhibit behavior dysregulation (Conners' Parent Rating Scale-Revised (S) of \> 60) following 3 months of SCMH at the KKFC.
- Children may have a history of receiving psychotropic medications or be currently taking stimulants at the time of study enrollment.
- Exclusion criteria:
- Children who are on psychotropic medications or medications that affect their heart rates, other than stimulants will be excluded from this preliminary study.
- Children with cardiac arrhythmias, endocrine disorders associated with heart rate irregularities or who are not able to cooperate or understand study procedures will be excluded.
- Non-English speaking children will be excluded. Children in foster care placements will be excluded.
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01524172
Start Date
January 1 2009
End Date
August 23 2017
Last Update
April 9 2018
Active Locations (1)
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1
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21231