Children's Bipolar Network Treatment Trial I
Recruiting · NCT05427123 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of California, Los Angeles
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a naturalistic treatment and follow-up study of youth with bipolar spectrum disorders (BSDs) across four US sites of The Childhood Bipolar Network (CBN). CBN sites have expertise in diagnosing, assessing, and treating BSDs in youth. The primary aims of this study are to (1) identify and reliably diagnose youth (ages 9 to 19 yrs) with full bipolar disorder (BD) and BSDs, and (2) examine predictors (e.g., mood instability, inflammatory marker C-reactive protein) of clinical outcome over a 12 month period. Participating youth will initially complete a screening that includes a structured diagnostic interview and a baseline blood draw to measure inflammatory processes. Youth with BSD and parents (80 families) will be asked to participate in multiple follow up research visits with interviews, rating instruments, and questionnaires. Per established CBN guidelines, study psychiatrists will provide and track medication management and sites will also track psychosocial treatments. This study ultimately aims to further understanding of best practice pediatric BSD psychiatric and psychosocial treatments and development of a standardized and validated set of clinical tools for patient assessment, diagnosis, and tracking.
Who can take part
Inclusion criteria
- Youth 9-19 years old
- Youth diagnosed with Bipolar disorder (I, II, Other Specified) or Cyclothymic Disorder by the study team during the diagnostic interview screening
- Youth is able to read and communicate in English to the degree necessary to be able to assent and participate (with help) in their treatment and assessments appropriate for ages 9 and up
- Youth has a caregiver able to participate in ongoing basis in assessment and treatment
- The participating caregiver can reliably read and communicate in English for purposes of study consenting, assessment, and treatment, unless preferred language translation services are regularly available.
Exclusion criteria
- Youth has DSM-5 diagnosis of autism spectrum disorder
- Youth has DSM-5 diagnosis of substance or alcohol abuse with impairment within 3 mos.
- Youth has a medical or psychiatric disorder that is life-threatening or requires immediate hospitalization or emergency medical or therapeutic treatment
- Evidence of recent sexual or physical abuse of the youth by legally responsible caregivers
- Evidence of recent intimate partner violence between caregivers responsible for the youth's care
Where it is running
4 locations listed across 4 US states.
- University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Program (CHAMP) - Los Angeles, California, United States
- University of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression Center - Aurora, Colorado, United States
- University of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS) - Pittsburgh, Pennsylvania, United States
- Virginia Commonwealth University Medical Center - Richmond, Virginia, United States