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Yoga Based Psychotherapy Group Feasibility and Efficacy Study

This study is currently recruiting participants.
Verified May 2016 by Harolyn M.E.Belcher, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01524172
First Posted: February 1, 2012
Last Update Posted: May 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Substance Abuse and Mental Health Services Administration (SAMHSA)
Information provided by (Responsible Party):
Harolyn M.E.Belcher, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  Purpose
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.

Condition Intervention Phase
Emotional Lability PTSD Behavioral: Yoga Based Psychotherapy Group Behavioral: Standard Mental Health Treatment Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Yoga Based Psychotherapy Group Feasibility and Efficacy Study

Resource links provided by NLM:


Further study details as provided by Harolyn M.E.Belcher, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Primary Outcome Measures:
  • To examine the feasibility of recruiting and conducting the proposed intervention and evaluation procedures on a cohort of children exposed to neglect and trauma and their caregivers using a randomized design. [ Time Frame: 8 years ]

Secondary Outcome Measures:
  • Examine the effects of YBMT on heart rate variability, behavior, post traumatic stress disorder symptoms, and functioning. [ Time Frame: 8 years ]

Estimated Enrollment: 300
Study Start Date: January 2009
Estimated Study Completion Date: November 2021
Estimated Primary Completion Date: November 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Mental Health Treatment
Trauma-informed evidence supported mental health treatment
Behavioral: Standard Mental Health Treatment
Trauma and evidence informed therapy
Experimental: Yoga Based Psychotherapy Group
Yoga Based Psychotherapy will be used as an adjunct mental health interventions
Behavioral: Yoga Based Psychotherapy Group
YBPG promotes self-regulation (attention span and physical and verbal expression/outbursts); self-soothing (breathing and movement techniques that physiologically calm when the child encounters stress or reminders of trauma); competency (successful social interaction, appropriate expression of needs and feelings, healthy coping with stress or crisis); self-awareness (of thoughts and feelings by first increasing awareness of the body and its sensations through yoga); self-esteem (positive self-regard, increase accomplishments and awareness that all individuals have different abilities); and safety and personal boundaries (establishing personal boundaries and respecting others' personal boundaries, differentiate safe and unsafe behaviors and situations).
Other Name: YBPG

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524172


Contacts
Contact: Harolyn ME Belcher, MD 443-923-5933 belcher@kennedykrieger.org

Locations
United States, Maryland
Kennedy Krieger Institute Recruiting
Baltimore, Maryland, United States, 21231
Contact: Harolyn ME Belcher, M.D.    443-923-5933    belcher@kennedykrieger.org   
Principal Investigator: Harolyn ME Belcher, MD         
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Substance Abuse and Mental Health Services Administration (SAMHSA)
Investigators
Principal Investigator: Harolyn ME Belcher, MD Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  More Information

Responsible Party: Harolyn M.E.Belcher, M.D., Director of Research, Family Center at Kennedy Krieger Institute, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT01524172     History of Changes
Other Study ID Numbers: NA_00021817
First Submitted: January 30, 2012
First Posted: February 1, 2012
Last Update Posted: May 20, 2016
Last Verified: May 2016

Keywords provided by Harolyn M.E.Belcher, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
child trauma exposure
mental health
yoga
mood regulation
child maltreatment


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