Yoga Based Movement Therapy Feasibility and Efficacy Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor:
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.
ClinicalTrials.gov Identifier:
NCT01524172
First received: January 30, 2012
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

This preliminary study will examine the feasibility of conducting a randomized clinical trial of Yoga Based Movement Therapy (YBMT)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 YBMT 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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Yoga Based Movement Therapy Feasibility and Efficacy Study

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 300
Study Start Date: January 2009
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2016 (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
YBMPG 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

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 30, 2012
Last Updated: September 26, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 20, 2014