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Emotional LabilityEarly Phase 1NCT01524172

Yoga Based Psychotherapy Group Feasibility and Efficacy Study

A Early Phase 1 study testing Yoga Based Psychotherapy Group and Standard Mental Health Treatment in people with Emotional Lability and PTSD, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 8 to 12 years
Conditions the study is for
Emotional Lability, PTSD
What is being tested?
Yoga Based Psychotherapy Group and Standard Mental Health Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Jan 2009to 23 Aug 2017
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Kennedy Krieger Institute

    Baltimore, Maryland, 21231

Other trials in United States

About this study

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.

Read the 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.
Being tested
Yoga Based Psychotherapy Group, Standard Mental Health Treatment
Keywords
child trauma exposure, mental health, yoga, mood regulation, child maltreatment
Medical subject headings
Stress Disorders, Post-Traumatic, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yoga Based Psychotherapy GroupBehavioural

    Also called YBPG

    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).

  • Standard Mental Health TreatmentBehavioural

    Trauma and evidence informed therapy

Study groups in NCT01524172
Study groupRoleWhat they receive
Standard Mental Health TreatmentActive comparatorTrauma-informed evidence supported mental health treatment
Receives: Behavioral: Standard Mental Health Treatment
Yoga Based Psychotherapy GroupExperimentalYoga Based Psychotherapy will be used as an adjunct mental health interventions
Receives: Behavioral: Yoga Based Psychotherapy Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 8 years

Secondary outcomes (1)
  1. Examine the effects of YBMT on heart rate variability, behavior, post traumatic stress disorder symptoms, and functioning.

    Improved behavior

    Measured: 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2012 (estimated)
  2. Study startJan 2009
  3. Primary completion23 Aug 2017
  4. Study completion23 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01524172
Sponsor's protocol ID
NA_00021817
Status last verified
Apr 2018
First submitted
30 Jan 2012
Last updated
9 Apr 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Yoga Based Psychotherapy Group and Standard Mental Health Treatment in people with Emotional Lability and PTSD, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018.

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