Yoga Based Movement Therapy Feasibility and Efficacy Study
This study is currently recruiting participants.
Verified February 2012 by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
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: February 3, 2012
Last verified: February 2012
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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 Movement Therapy |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel 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: 4 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: 4 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (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: Yoga Based Movement Therapy
YBMT 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: YBMT
|
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
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: | February 3, 2012 |
| 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 May 19, 2013