Self Regulation with Biofeedback

Dyregulation is a major finding in children impacted by trauma and neglect. Dysregulation interferes with attachment and bonding with a caregiver, and limits benefits from other interventions. We plan to teach 75 children ages 8-17 years, self regulation through heart rhythm coherence feedback training(HRCFT), a form of biofeedback that can lead to improvement of physiologic coherence and increase heart rate variability. Increased heart rate varaibility has been associated with better emotional and behavioral regulation. We plan to compare 2 groups of children (75 in each group), 1 group receiving standard care mental health,(SCMH), and the other receiving SCMH +HRCFT over a 12 week period. Behavior, functioning and heart rate variability will be measured with questionnaires at baseline, 3 months, 6 months and 12 months after the start of the intervention. It is hypothesized that teaching a child self regulation with heart rhythm coherence feedback training will increase the heart rate variability and will result in better self regulation and improved behavior and functioning.

One hundred fifty (150) medication naïve children (ages 8-17 years) and their caregivers (total N =300 individuals) will be enrolled in this randomized preliminary study over a three year period. Biological or legal guardian caregivers of children treated at the Kennedy Krieger Family Center (KKFC) who have a history of neglect +/- (community or family) trauma exposure, and who have difficulty with behavior regulation, as measured by a T-score > 60 on any of the Child Behavior Checklist Parent Rating Scales (CBCL) will be invited to participate. Following informed consent, children will be evaluated by one of the KKFC child psychiatrists who will be unaware of the child’s study participation status. Clinical evaluation will determine whether medication is appropriate/desirable for the child and whether the child/family environment is stable and safe. If the child is deemed appropriate for psychotropic medication, he 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). If, however, there is failure to obtain eligible participants after 2 months of the study initiation, children taking medications will be accepted to the study and medication dose and type will be recorded and analyzed as a co-variate. A block randomization design, to increase the likelihood of equal distribution of mean total CBCL scores in treatment and standard care group, will be used to assign children to either standard care mental health treatment (SCMH) or 12 weeks of heart rhythm coherence feedback training (HRCFT) using the EmWave PC in addition to SCMH.

The Emwave PC will be used for heart rhythm coherence feedback training (HRCFT) ( see eIRB supplemental information section). The instrument, which consists of an earlobe sensor attached to a computer, allows the child to become aware of their physiological and autonomic state through the use of auditory and visual feedback. 

Risks: Assessments are non-invasive and low risk. Should the child’s behavior deteriorate (in either arm of the study) a referral will be made to Child Psychiatry where the child will be re-assessed for safety and possible medication management