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| Name | Class |
|---|---|
| Substance Abuse and Mental Health Services Administration (SAMHSA) | FED |
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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.
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.]
The child will be randomized to Group 1: to continue Standard Care Mental Health (SCMH) treatment or Group 2: Standard Mental Health and Yoga Based Psychotherapy Group.
Children with T-scores lower than 60 will continue in Standard Mental Health Treatment. Recruitment will take place over three years.
A block randomization design (block size 4) will be used to ensure roughly equal distribution of YBPG and SCMH patients over the enrollment time. An opaque bag with four colored marbles (two red, two black) will be utilized for the randomization. The child, in the presence of the parent, will be asked to select a colored marble out of the bag; the marbles will be replaced after enrollment of sets of 4 children. Depending on the color of the marble the child will be assigned to either YBPG or SCMH.
Children randomized to YBPG must be cleared by their pediatric care provider (Appendix 1). Children in YBPG group will participate in YBPG as outlined in Appendix 2; participation duration is expected to be 12 weeks. Parents in the YBPG group will participate in a psychoeducational intervention to learn about YBPG and support the child's practice of YBPG. Following 12 weeks of YBPG children will resume SCMH if necessary.
Children will be assessed following informed consent, at 3 months (following YBPG or 6 months of SCMH), 6 months, and 12 months following randomization.
Assessments:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Mental Health Treatment | Active Comparator | Trauma-informed evidence supported mental health treatment |
|
| Yoga Based Psychotherapy Group | Experimental | Yoga Based Psychotherapy will be used as an adjunct mental health interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga Based Psychotherapy Group | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Acceptance rate | 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Examine the effects of YBMT on heart rate variability, behavior, post traumatic stress disorder symptoms, and functioning. | Improved behavior | 8 years |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harolyn ME Belcher, MD | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kennedy Krieger Institute | Baltimore | Maryland | 21231 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
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| Standard Mental Health Treatment | Behavioral | Trauma and evidence informed therapy |
|
| D001519 | Behavior |