Clinical trial NCT05427123: Children's Bipolar Network Treatment Trial I
Official title: A Collaborative Treatment Network for Youth With or at High Risk for Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bipolar Disorder
Bipolar I Disorder
Bipolar II Disorder
Other Specified Bipolar and Related Disorder
Mood Instability
Child Mental Disorder
Adolescent - Emotional Problem
Keywords: medication
psychosocial
treatment
longitudinal
naturalistic
assessment
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: Virginia Commonwealth University
name: University of Colorado, Denver
name: Milken Institute
name: Baszucki Brain Research Fund
First posted: 2022-06-22
Enrollment: 80
Sex: ALL
Minimum age (years): 9
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited and followed through the University of California, Los Angeles (UCLA) Child and Adolescent Mood Disorders Program. Some families elected to be contacted directly about future studies such as this one during general screening or consenting for prior studies. Participants will also be recruited under similar protocols at additional study sites including the Virginia Treatment Center for Children (VTCC) and University of Pittsburgh Child and Adolescent Bipolar Spectrum Services (CABS). Participants at University of Colorado Anschutz Medical Campus study site will be recruited from the Johnson Depression Center and Summit Child Clinic.

Brief summary: 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.

Detailed description: Study Background and Significance

Cross-site research networks for specific childhood diseases have led to important treatment advances, such as guidance of optimizing treatments for individual patients and significant reductions in childhood mortality. The Childhood Bipolar Network (CBN) is a similar type of research collaboration developed to support advancements to the understanding and treatment of pediatric bipolar spectrum disorders (BSDs), starting with this first study. The study builds on recent advances in the early identification and reliable diagnosis of pediatric BSDs. It also builds on advances in treatment for youth with or at high risk for BSD, such as the finding from randomized clinical trials showing that family intervention plus pharmacotherapy is consistently associated with superior symptomatic, suicidal, and functional outcomes compared with either usual care or supportive therapy plus pharmacotherapy.

Specific Aims of the Study

The aims of the first study with 80 youth are to (1) identify and reliably diagnose diverse youth (9 to 19 yrs) with BSD I, II, and Other Specified Bipolar Disorder (OSBD, formerly called Bipolar Disorder Not Otherwise Specified) across collaborative clinics in the US; and (2) examine predictors of 1-year treatment response in youth with BSDs, using treatment methods and instrumentation harmonized across four sites. This study will examine mood instability and an inflammatory marker based on a blood test (C-reactive protein) as primary predictors of outcomes.

Study phases and outcomes include: I. Recruitment and screening, II. Intake (blood draw, medical history, structured diagnostic interview, youth mood symptom and instability measures, youth and family functioning measures), III. Weekly parent online reporting on youth symptoms and functioning, IV. Follow-up at 6 and 12 months for repeated measures and relevant updates.

Study milestones will include cross-site harmonization of assessment and treatment methods, validation of a mood instability phenotype, and development of an open trial infrastructure for novel treatments for youth with or at risk for BSD. The development of a standardized BSD clinical assessment and care procedure across US centers is critical to the broader effort to develop robust treatment algorithms and empirically based guidelines for use in a wide variety of national and international health care settings with culturally heterogeneous populations of youth with or at risk for BSD.

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

Primary outcomes:
measure: Change in Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE) Psychiatric Status Ratings
timeFrame: The measure will be administered at 0, 6, and 12 months.
measure: Change in Children's Affective Lability Scale (CALS), Child and Parent Report forms
timeFrame: The measure will be administered at 0, 6, and 12 months.
measure: Change in Conflict Behavior Questionnaire (CBQ) scores, Child and Parent Report forms
timeFrame: The measure will be administered at 0, 6, and 12 months.
measure: Kiddo-KINDL Quality of Life Questionnaire for Children, Child and Parent Reports forms
timeFrame: The measure will be administered at 0, 6, and 12 months.
Secondary outcomes:
measure: Change in Parents' Online Weekly Evaluation and Rating Scale (POWERS), Parent Report form
timeFrame: The measure will be administered at 0 months and then weekly through 12 months.
measure: Change in General Behavior Inventory, Parent Version Short form (P-GBI)
timeFrame: The measure will be administered at 0, 6, and 12 months.
measure: Change in Mood and Feelings Questionnaire (MFQ), Child and Parent Report forms
timeFrame: The measure will be administered at 0, 6, and 12 months.
measure: Change in Self-Report for Childhood Anxiety Related Disorders (SCARED), Child Report form
timeFrame: The measure will be administered at 0, 6, and 12 months.
measure: Drug Use Screening Inventory, Revised (DUSI-R), Child Report form
timeFrame: The measure will be administered at 0, 6, and 12 months.
measure: Change in Positive and Negative Affect Schedule for Children (PANAS-C-SF), Child Report Short form
timeFrame: The measure will be administered at 0, 6, and 12 months.
measure: Change in Perceived Criticism on Perceived Criticism Scale (PC), Child Report form
timeFrame: The measure will be administered at 0, 6, and 12 months.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Program (CHAMP)
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression Center
state: Colorado
city: Pittsburgh
country: United States
facility: University of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS)
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
Study officials:
affiliation: University of California, Los Angeles
name: David J Miklowitz, PhD
role: PRINCIPAL_INVESTIGATOR
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