Evaluating Best Practices in Neurobehavioral Inpatient Psychiatry

Our multidisciplinary research team spearheads efforts to develop evidence-based treatment protocols for youth and young adults with neurodevelopmental disabilities (NDDs) such as autism spectrum disorder and co-occurring severe mental illness or significant challenging behaviors. Most research protocols generally exclude youth with profound autism and other NDDs due to their behaviors, intellectual disability or language impairments. Recently awarded a Cincinnati Children's Place Outcomes Research Award, Division of Psychiatry faculty Martine Lamy, MD, PhD, along with Division of Behavioral Medicine and Clinical Psychology faculty Rebecca Shaffer, PsyD, and Lauren Schmitt, PhD, are adapting Regulating Together, a transdiagnostic emotion regulation treatment program, into a format designed for youth with intellectual disability and significant language impairments. In addition to examining the feasibility and acceptability of using this treatment program with youth with profound autism, this study will also examine the impact of implementing the structured emotion regulation curriculum on the inpatient neurobehavioral psychiatry unit on measures of staff burnout and staff safety. This Place Outcomes Research Award aligns with several quality improvement efforts within neurobehavioral psychiatry to improve staff and patient safety.

In addition, the Cincinnati Children's Neurobehavioral Psychiatry Inpatient Unit, led by Lamy is a primary site for the Autism and Developmental Disorders Inpatient Research Collective (ADDIRC), a comprehensive registry of clinical and biologic data on severely affected children and adolescents with autism. In addition, they are also a founding member of the National Autism and intellectual Disability Psychiatric Care Collaborative (NAID-PCC), a national organization dedicated to establishing standards and performance improvement for inpatient psychiatry units caring for youth with autism and intellectual disability. Led by Division of Psychiatry faculty Craig Erickson, MD, and Lam, the Neurobehavioral Psychiatry Inpatient unit is also a site for the CALM201 study, a proof-of-concept study for the Acute Treatment of Agitation in Adolescents with Autism Spectrum Disorders. The CALM201 study is a first-of-its-kind Phase2a study enrolling participants with autism and severe behavior during inpatient crisis hospitalizations to evaluate the safety and efficacy of INP105, a novel combination product that sprays a powder formulation of olanzapine to the upper nasal space with a rapid rate of absorption. In addition to the research efforts, the Neurobehavioral Inpatient Psychiatry team received a recent award of a patient family experience grant to improve family involvement in inpatient care and was a finalist for the Schwartz Center Compassionate Caregiver Award. The Neurobehavioral Inpatient Psychiatry team routinely presents their work at national and international conferences and hosts institutions from around the world that are interested in improving the care of individuals with significant neurodevelopmental disabilities within their systems.

Using Accelerated Brain Stimulation to Treat Severe Depression in Autism

Last year the Division of Psychiatry received competitive development funds to pilot a non-drug approach to treat severe depression in individuals with autism. Depression is a leading cause of disability and disproportionately affects individuals with autism. Tragically, individuals with autism are four times more likely to develop depression and nine times greater risk of suicide. Depression can worsen impairments already associated with autism, including social withdrawal, medical conditions and irritability (including self-injury). Often, standard of care treatments such as antidepressant medications may be ineffective or unpredictable.

Cincinnati Children's is a well-known center for using brain stimulation to treat neuropsychiatric disease. Repetitive transcranial magnetic stimulation (TMS), in particular, is a biological and non-pharmaceutical treatment for depression with strong meta-analysis and controlled trial support (n > 1000 patients) and is covered by most insurers. TMS pulses can activate deeper brain tissues through the scalp. However, conventional TMS therapy involves high-intensity pulses over 40-minute sessions for four to six weeks. The duration of therapy and sensory concerns limit the scalability of TMS in the autism population, regardless of potential benefits.

Ernest Pedapati, MD, MS, FAAP, (PI; Divisions of Psychiatry and Neurology) along with Craig Erickson, MD, (Division of Psychiatry), Donald Gilbert, MD, MS, (Division of Neurology), and Steve Wu, MD, (Division of Neurology) proposed a trial of using low-intensity, high-power and rapid TMS to treat severe depression in autism. The accelerated theta burst stimulation (aTBS) delivers a full course of TMS therapy in thirty three-minute low-intensity sessions over ten days. Executed by Elizabeth Blank (clinical research coordinator; Division of Psychiatry), the team completed eight subjects in an ongoing trial and demonstrated a marked improvement in depression severity, with seven out of eight achieving full remission of symptoms. We also found unexpected improvements in fluid cognition and sleep. Psychologists involved in performing key assessments are from the Division of Developmental and Behavioral Pediatrics and Behavioral Medicine and Child Psychology. We also collected brain-based electroencephalograms to identify biomarkers that may predict treatment response.

Thus far, these promising results led to a full U.S. Department of Defense application which proposed a larger randomized control trial to determine the safety and effectiveness of aTBS in treating depression in autism. We believe that aTBS to the frontal cortex can rapidly treat depression in autism compared to sham treatment. We will partner with the Department of Radiology to also obtain structural neuroimaging precisely identify which portion of the brain TMS targeted. As part of this proposal, we will conduct structured interviews of stakeholders (participants and caregivers) to better understand recurring themes, barriers and facilitators associated with treatment and recovery. The study team is confident that our application will be well received and hopeful that, if conducted, would provide a new innovative option for treating depression in individuals with autism. We are very grateful for the institutional support to undertake the complex pilot study, including acquiring a clinical-grade TMS machine, benefactor support and institutional support on a complex grant application.