Children's Bipolar Network Treatment Trial I

NCT05427123 | Recruiting

• 1 other identifier: IRB#22-000309
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

medication; psychosocial; treatment; longitudinal; naturalistic; assessment

Outcome Measures

Primary Outcomes (4)

• Change in Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE) Psychiatric Status Ratings

  The A-LIFE is a measure of severity of youth mood symptoms and episodes, including first episode onset, duration, recovery, and recurrence. Independent evaluators administer the A-LIFE interview to the youth and one parent, and rate each week of the prior 6 month interval (i.e., 6 months prior to intake) on Psychiatric Status Ratings (PSRs) of depression, hypomania, mania, and suicidality. The minimum and maximum Psychiatric Status Ratings values are 0 and 6 respectively, with higher Psychiatric Status Ratings meaning worse psychiatric severity.

  The measure will be administered at 0, 6, and 12 months.

• Change in Children's Affective Lability Scale (CALS), Child and Parent Report forms

  CALS is a measure of youth mood lability and yields subscores for elevation/activation, irritability, and anxiety-depression. It consists of 20 items covering the prior 3 months: "Suddenly becomes tense or anxious…has bursts of being overly affectionate or silly….starts to laugh or cry…suddenly appears sad, depressed, for no reason." The CALS uses a five level Likert scale, from 0 (never or rarely occurs) to 4 (occurs 1 or more times a day). Total score for the 20 items can vary from 0 to 80, with lower scores indicating a lesser degree of affective lability.

  The measure will be administered at 0, 6, and 12 months.

• Change in Conflict Behavior Questionnaire (CBQ) scores, Child and Parent Report forms

  The CBQ assesses the degree of aversive communication and conflict experienced in a child/parent dyad over the prior 3 months. The 20 scale items are rated "true/false" and cover argumentativeness (e.g., "At least three times a week, we get angry at each other"), frustration in communication, degree of empathy (e.g., "My mother understands me"), and relationship quality (e.g. "I don't think we get along very well"). The child fills out separate CBQs regarding conflict with each primary caregiver. Total scores range from 0 to 20. Higher scores represent more conflict including negative communications.

  The measure will be administered at 0, 6, and 12 months.

• Kiddo-KINDL Quality of Life Questionnaire for Children, Child and Parent Reports forms

  This Kiddo-KINDL is a measure of youth quality of life in five domains (Emotional Well-being, Self-esteem, Family, Social Contacts, School). Items (e.g., "I did things together with my friends") are rated by the adolescent and parent on a Likert scale from 1 (never) to 5 (all the time) for the past week. The parent form contains items that pertain to the youth's quality of life while the child form pertains to the youth patient. Subscales represent each domain with scores range from 4 to 20. Total scale scores range from 20 to 100. Higher scores on subscales or the total scale mean greater quality of life.

  The measure will be administered at 0, 6, and 12 months.

Secondary Outcomes (7)

• Change in Parents' Online Weekly Evaluation and Rating Scale (POWERS), Parent Report form

  The measure will be administered at 0 months and then weekly through 12 months.

• Change in General Behavior Inventory, Parent Version Short form (P-GBI)

  The measure will be administered at 0, 6, and 12 months.

• Change in Mood and Feelings Questionnaire (MFQ), Child and Parent Report forms

  The measure will be administered at 0, 6, and 12 months.

• Change in Self-Report for Childhood Anxiety Related Disorders (SCARED), Child Report form

  The measure will be administered at 0, 6, and 12 months.

• Drug Use Screening Inventory, Revised (DUSI-R), Child Report form

  The measure will be administered at 0, 6, and 12 months.

Study Arms (1)

Youth with or at clinical high risk for Bipolar Spectrum Disorder

Youth included in the study will have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of Bipolar I or II, Cyclothymic Disorder, or Other Specified Bipolar Disorder (per Course and Outcome of Bipolar Youth study definition)

Other: Medication or psychosocial treatment

Interventions

Medication or psychosocial treatment OTHER

Youth included in this naturalistic study will be offered medication management from study psychiatrists. The study's Network Oversight Committee, consisting of PI psychiatrists and consultants, has created guidelines on best practice medications, dosing, and adjustments for the study. The Network Oversight Committee will also offer ongoing consultation to study psychiatrists. The treating physician will take these guidelines and recommendations under consideration but will use clinical judgment and have the final say, in consultation with the parents and child, as to what treatments are prescribed. While psychosocial interventions are of interest as a predictor of outcomes, no universal psychotherapy or other psychosocial treatment will be provided by sites. There is no limitation on participant enrollment in psychosocial treatments. Investigators and their clinical partners may offer these interventions based on clinical judgment and availability.

Youth with or at clinical high risk for Bipolar Spectrum Disorder

Eligibility Criteria

• Age: 9 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of Pittsburgh: collaborator
• Virginia Commonwealth University: collaborator
• University of Colorado, Denver: collaborator
• Milken Institute: collaborator
• Baszucki Brain Research Fund: collaborator

Study Sites (4)

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

Los Angeles, California, 90024, United States

RECRUITING

University of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression Center

Aurora, Colorado, 80045, United States

ENROLLING BY INVITATION

University of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS)

Pittsburgh, Pennsylvania, 15213, United States

ENROLLING BY INVITATION

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

ENROLLING BY INVITATION

Related Publications (31)

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Related Links

• UCLA Max Gray Child and Adolescent Mood Disorders Program (CHAMP) Website in Los Angeles, CA
• Child and Adolescent Bipolar Spectrum Services (CABS) at Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center (UPMC) in Pittsburgh, PA
• Virginia Commonwealth University (VCU) Medical Center Cameron K. Gallagher Mental Health Resource Center Virginia Treatment Center for Children (VTCC)

Biospecimen

Retention: SAMPLES WITHOUT DNA

Specimens (i.e., blood samples) obtained for routine lab testing (assays of C-Reactive Protein) will be discarded or destroyed once used for the purposes described in the protocol.

MeSH Terms

Conditions

Bipolar Disorder; Neurodevelopmental Disorders

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• David J Miklowitz, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David J Miklowitz, PhD

CONTACT

(310) 267-2659; dmiklowitz@mednet.ucla.edu

Danielle M Denenny, PhD

CONTACT

(323) 475-8252; ddenenny@mednet.ucla.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Psychiatry

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: June 22, 2022
• Study Start: July 1, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (4)