RECRUITING

Children's Bipolar Network Treatment Trial I

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-07-01
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05427123

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.

Ages Eligible for Study:9 Years to 19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Youth 9-19 years old
  2. * Youth diagnosed with Bipolar disorder (I, II, Other Specified) or Cyclothymic Disorder by the study team during the diagnostic interview screening
  3. * 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
  4. * Youth has a caregiver able to participate in ongoing basis in assessment and treatment
  5. * 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.
  1. * Youth has DSM-5 diagnosis of autism spectrum disorder
  2. * Youth has DSM-5 diagnosis of substance or alcohol abuse with impairment within 3 mos.
  3. * Youth has a medical or psychiatric disorder that is life-threatening or requires immediate hospitalization or emergency medical or therapeutic treatment
  4. * Evidence of recent sexual or physical abuse of the youth by legally responsible caregivers
  5. * Evidence of recent intimate partner violence between caregivers responsible for the youth's care

Contacts and Locations

Study Contact

David J Miklowitz, PhD
CONTACT
(310) 267-2659
dmiklowitz@mednet.ucla.edu
Danielle M Denenny, PhD
CONTACT
(323) 475-8252
ddenenny@mednet.ucla.edu

Principal Investigator

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

Study Locations (Sites)

University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Program (CHAMP)
Los Angeles, California, 90024
United States
University of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression Center
Aurora, Colorado, 80045
United States
University of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS)
Pittsburgh, Pennsylvania, 15213
United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-01
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2022-07-01
Study Completion Date2026-07-01

Terms related to this study

Keywords Provided by Researchers

  • medication
  • psychosocial
  • treatment
  • longitudinal
  • naturalistic
  • assessment

Additional Relevant MeSH Terms

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