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Children's Bipolar Network Treatment Trial I
A Collaborative Treatment Network for Youth With or at High Risk for Bipolar Disorder
Who can join
Ages 9 to 19 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Medication or psychosocial treatment (other)
Sponsor: University of California, Los Angeles · Participants: 80 · Started: Jul 1, 2022
Contact the study team
- David J Miklowitz, PhD · Phone: (310) 267-2659
- Danielle M Denenny, PhD · Phone: (323) 475-8252
Official record on ClinicalTrials.gov — NCT05427123
Locations in the U.S.
| California | University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Program (CHAMP), Los Angeles |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.