Yoga Based Psychotherapy Group Feasibility and Efficacy Study
Condition: Emotional Lability; PTSD
Study type: Interventional
Phase: Early Phase 1

Summary: 
      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.
    

Detailed description: 
      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:

        1. Baseline EKG and respiratory rate (RR) will be measured for 5 minutes. Heart rate
           variability will be measured using a data collection system that will take EKG and
           respiratory rate recordings for 5 minutes, and analyzed using the CardioBatch software
           from the Brain Body Center of the University of Illinois. The Trier Social Stress Test
           13 for children will be administered. The Trier consists of the research assistant
           telling the child the beginning of a story and having the child complete the story in 5
           minutes. Then the child is asked to perform math problems for 5 minutes. EKG and
           respiratory rate (RR) will be re-measured for 10 minutes after the Trier.

        2. Child Behavior Checklist (CBCL) 14;15. The CBCL is a written measure designed to assess
           behavioral and emotional problems in children. There are several forms including a
           version for children from 1 1/2 to 5 years and a version for children 6-18 years 14;15.
           There are also Parent, Youth, and Teacher rating forms. The Youth Behavior Rating will
           be used to obtain a self-report of the child's behavioral and emotional status. Each
           version yields standard scores (Mean = 50, standard deviation = 10) to assess behavior
           problems in several specific areas; these scores are also combined into three global
           scores: an Internalizing score for emotional problems, an Externalizing score for
           behavior problems, and a Total problem score. The Parent Questionnaire form of the CBCL
           will be used. The CBCL is expected to take 20 minutes to complete.

        3. Trauma Symptom Checklist for Young Children (TSCYC) and Trauma Symptom Checklist for
           Children (TSCC) 16: The TSCYC is a 90-item parent report of children's symptoms
           associated with traumatic events (e.g., child abuse, peer assaults, community violence).
           The TSCYC is normed and standardized as a trauma measure for children ages three to 12
           years and includes measurements of validity of parent report and norms for the number of
           waking hours the parent spends with the child during an average week. The instrument
           includes nine subscales, Post-traumatic Stress-Intrusion, Post-traumatic
           Stress-Avoidance, Post-traumatic Stress-Arousal, Post-traumatic Stress-Total, Sexual
           Concerns, Dissociation, Anxiety, Depression, and Anger/Aggression. The TSCYC is expected
           to take 15-20 minutes to complete. Alpha values on a multi-site clinical sample of
           traumatized children ranged from 0.81 for Sexual Concerns to 0.93 for Post-traumatic
           Stress-Total17. The TSCC is a 54 item child questionnaire that has Anxiety, Depression,
           Anger, Posttraumatic Stress, Dissociation, and Sexual Concerns. Alpha values range from
           0.77 for Sexual Concerns to 0.89 for Anger. The TSCC is expected to take 10-15 minutes
           to complete.

        4. Behavior Emotional Rating Scale (BERS-2) 18: The BERS-2 is a 52-item Likert scale that
           measures the children emotional and behaviors strengths through parent, child, and
           observer report. The BERS-2 is designed for children ages 5 years to 18 years and is
           divided into five subscales, namely, (1) Interpersonal Strengths, (2) Family
           Involvement, (3) Intrapersonal Strengths, (4) School Functioning, and (5) Affective
           Strengths. Teacher/Clinician, Parent, and Youth Rating Scales will be used in this grant
           to assess child behavioral and emotional functioning. Cultural/ethnic normative sample
           were representative of the United States population. Internal consistency ranges from
           0.77 to 0.99. The BERS is expected to take 15 minutes to complete.

        5. The University of California Los Angeles-Post Traumatic Stress Disorder (UCLA-PTSD) is
           used to screen both for exposure to traumatic events and for DSM-IV PTSD symptoms in
           children and adolescents who report traumatic experiences. The UCLA PTSD is expected to
           take approximately 15 minutes.

        6. The Ontario Child Neglect Index (CNI) is a clinician administered assessment designed to
           identify types and severity of different forms of child neglect. It is designed for use
           with families already identified by a child protective service agency. The CNI is a
           6-scale index and utilizes a 4- to 5-level rating of severity (e.g., adequate,
           inconsistent, inadequate, seriously inadequate). The score is interpreted as a severity
           rating of neglect, rather than a binary (yes/no) neglect score. Scores can range from
           0-80. The recommended cutoff score is 50. The CNI is expected to take approximately 5
           minutes to complete.

        7. Demographic information (e.g, gender, age, race/ethnicity, parental age, education,
           employment, marital status, etc.) will be collected. In addition, medical information
           including medications, psychiatric diagnosis, birth history, history of maltreatment and
           psychosocial history will be obtained by parent interview or electronic record review.
    

Intervention name(s): Yoga Based Psychotherapy Group; Standard Mental Health Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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).; Trauma and evidence informed therapy
Other intervention name(s): YBPG
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: child trauma exposure; mental health; yoga; mood regulation; child maltreatment