Yoga Based Psychotherapy Group Feasibility and Efficacy Study

Completed · Early Phase 1

Conditions studied: Emotional Lability, PTSD

In brief

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 children ages 8-12 years who have a history of neglect and maltreatment (trauma). The goal of the study is to inform the method and sample size for a larger randomized trial to study the effect of YMBT with SCMH compared to SCMH in improving child regulation of behavior, emotions, and daily functioning. Children who have experienced trauma, including sexual abuse, physical abuse, emotional abuse, exposure to community or domestic violence, parental substance abuse, mental health disorders, and incarceration are at risk to have dysregulation of mood, emotions and behavior. In addition, children exposed to neglect and trauma may have poor attachment to caregivers and poor peer relations. It is hypothesized the using YBPG as an adjunct to SCMH may improve children's regulation of emotion and behavior.

Key facts

Study ID

NCT01524172

Run by

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

People needed

20

Starts

2009-01-01

Expected to finish

2017-08-23

Last updated by the study team

2018-04-09

Who can join

Age: 8 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kennedy Krieger Institute — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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