Children's Bipolar Network Treatment Trial I

Description

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.

Conditions

Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder, Other Specified Bipolar and Related Disorder, Mood Instability, Child Mental Disorder, Adolescent - Emotional Problem

Study Overview

Study Details

Study overview

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.

A Collaborative Treatment Network for Youth With or at High Risk for Bipolar Disorder

Children's Bipolar Network Treatment Trial I

Condition
Bipolar Disorder
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Program (CHAMP), Los Angeles, California, United States, 90024

Aurora

University of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression Center, Aurora, Colorado, United States, 80045

Pittsburgh

University of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS), Pittsburgh, Pennsylvania, United States, 15213

Richmond

Virginia Commonwealth University Medical Center, Richmond, Virginia, United States, 23298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

9 Years to 19 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Los Angeles,

David J Miklowitz, PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

2026-07-01