Yoga Based Psychotherapy Group Feasibility and Efficacy Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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 to be enrolled in this randomized preliminary study if CCTFS Clinician identifies that the child is continuing to have difficulty with behavior and emotional regulation. Children will be invited to participate in the study. Informed consent will be obtained following explanation of the study. If the child meets both Stage 1 and 2 Screening criteria,
Stage 1 Screening:
Child receives a T-score > 60 on any of the Child Behavior Checklist Parent Rating Scales, and
Stage 2 Screening:
KKFC Psychiatric evaluation (Child Psychiatrist will be masked to study status). Child Psychiatrist evaluation will determine whether medication is appropriate for the child and whether the child/family environment is stable and safe. If the child is deemed appropriate for psychotropic medications, other than stimulants, the child will not be eligible for the study (due to the possible changes in one of the outcome measures, heart rate variability, that will likely result from use of psychotropic medications that can not be stopped 24 hours prior to study evaluation). [Children on stimulant medication will be asked to stop medication one day prior to study evaluation and of the day of evaluation.]
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Standard Mental Health Treatment
Trauma-informed evidence supported mental health treatment
干预措施: Standard Mental Health Treatment (Behavioral)
Yoga Based Psychotherapy Group
Yoga Based Psychotherapy will be used as an adjunct mental health interventions
干预措施: Yoga Based Psychotherapy Group (Behavioral)
结局指标
主要结局
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.
时间窗: 8 years
Acceptance rate
次要结局
- Examine the effects of YBMT on heart rate variability, behavior, post traumatic stress disorder symptoms, and functioning.(8 years)
研究者
Harolyn M.E.Belcher, M.D.
Director of Research, Family Center at Kennedy Krieger Institute
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.