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Children's Bipolar Network Treatment Trial I (CBN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05427123
Recruitment Status : Recruiting
First Posted : June 22, 2022
Last Update Posted : July 21, 2022
Sponsor:
Collaborators:
University of Pittsburgh
Virginia Commonwealth University
University of Colorado, Denver
Information provided by (Responsible Party):
David J. Miklowitz, Ph.D., University of California, Los Angeles

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.

Condition or disease Intervention/treatment
Bipolar Disorder Bipolar I Disorder Bipolar II Disorder Other Specified Bipolar and Related Disorder Mood Instability Child Mental Disorder Adolescent - Emotional Problem Other: Medication or psychosocial treatment

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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Collaborative Treatment Network for Youth With or at High Risk for Bipolar Disorder
Actual Study Start Date : July 1, 2022
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Change in Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE) Psychiatric Status Ratings [ Time Frame: The measure will be administered at 0, 6, and 12 months. ]
    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.

  2. Change in Children's Affective Lability Scale (CALS), Child and Parent Report forms [ Time Frame: The measure will be administered at 0, 6, and 12 months. ]
    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.

  3. Change in Conflict Behavior Questionnaire (CBQ) scores, Child and Parent Report forms [ Time Frame: The measure will be administered at 0, 6, and 12 months. ]
    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.

  4. Kiddo-KINDL Quality of Life Questionnaire for Children, Child and Parent Reports forms [ Time Frame: The measure will be administered at 0, 6, and 12 months. ]
    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.


Secondary Outcome Measures :
  1. Change in Parents' Online Weekly Evaluation and Rating Scale (POWERS), Parent Report form [ Time Frame: The measure will be administered at 0 months and then weekly through 12 months. ]
    The POWERS is a measure of the severity of youth psychopathology across several symptom domains. Parents rate six symptom domains (anxiety, depression, attention deficit hyperactivity disorder, oppositional defiance, manic, overall symptoms) on symptom severity (0=none to 3=severe) and frequency (0= rarely to 3= almost all of the time) for the past week. Total scale score ranges from 0 to 36, while symptom severity and frequency subscales each range from 0 to 18. Higher scores represent greater psychopathology.

  2. Change in General Behavior Inventory, Parent Version Short form (P-GBI) [ Time Frame: The measure will be administered at 0, 6, and 12 months. ]
    The P-GBI Mania scale is a measure of youth hypomanic/biphasic symptom severity. An example item is "Has your child's mood or energy shifted rapidly back and forth from happy to sad or high to low?" 10 items are each rated by parents on a Likert scale ranging from 1 (never or hardly ever) to 4 (very often or almost constantly) for the past six months. Total scores range from 10 to 40, with higher scores representing greater youth hypomanic/biphasic symptom severity.

  3. Change in Mood and Feelings Questionnaire (MFQ), Child and Parent Report forms [ Time Frame: The measure will be administered at 0, 6, and 12 months. ]
    The MFQ is a measure of severity of youth suicidal ideation and depression. Example items include "I didn't enjoy anything at all," "I thought about death or dying," and "I slept a lot more than usual." The youth or parent rates 33 items as "not true" (0), "sometimes true (1) or "true" (2) for the past two weeks. Total scores range from 0 to 66, with higher scores representing greater severity of suicidal ideation and depression.

  4. Change in Self-Report for Childhood Anxiety Related Disorders (SCARED), Child Report form [ Time Frame: The measure will be administered at 0, 6, and 12 months. ]
    The SCARED is a measure of severity of youth anxiety severity and types of anxiety or worry. An example item is "When I feel frightened, it is hard to breathe." The 41-items are rated by as "Not True or Hardly Ever True" (0), "Somewhat True or Sometimes True" (1), or "Very True or Often True" (2). Total scores range from 0 to 82, with higher scores representing greater severity of anxiety and worry. A total score of ≥ 25 may indicate the presence of an Anxiety Disorder

  5. Drug Use Screening Inventory, Revised (DUSI-R), Child Report form [ Time Frame: The measure will be administered at 0, 6, and 12 months. ]
    DUSI-R is a measure of frequency and severity of drug and alcohol use for the prior month. Participants are instructed to "darken the circle that applies to the number of times you have used each of the drugs listed below in the last month." Item ratings range from 0=no times to 4=More than 20 times. The youth rates 15 additional severity items as yes (0) or no (1), with an example item being "Have you had a craving or very strong desire for alcohol or drugs?" The interviewer may assist with form completion to ensure understanding and completion. Total severity scale scores range from 0 to 15, with higher scores representing more severe substance use.

  6. Change in Positive and Negative Affect Schedule for Children (PANAS-C-SF), Child Report Short form [ Time Frame: The measure will be administered at 0, 6, and 12 months. ]
    PANAS-C-SF is a measure of youth positive and negative affect. Instructions are to "Please indicate how much you have felt this way over the past 15 minutes," with youth asked to rate eight emotions on 5-point Likert scales from 1=Not much at all to 5=a lot for six consecutive days. Four items comprise the positive affect subscale (joyful, happy, lively, proud) while another four items comprise the negative affect subscale (miserable, mad, scared, sad). Subscale scores range from 4 to 20, with higher scores representing more affect.

  7. Change in Perceived Criticism on Perceived Criticism Scale (PC), Child Report form [ Time Frame: The measure will be administered at 0, 6, and 12 months. ]
    The Perceived Criticism (PC) scale measures severity of perceived parental criticism. Youth make a weekly rating for any primary parental figures of "How critical is your parent of you?" and "When this parent criticizes you, how upset do you get?" on scales ranging from 1 (not at all) to 10 (extremely). Total scores range from 2 to 20 with higher scores representing greater perceived criticism.


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   9 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05427123


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

Locations
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United States, California
University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Program (CHAMP) Recruiting
Los Angeles, California, United States, 90024
Contact: David J Miklowitz, PhD    310-267-2659    dmiklowitz@mednet.ucla.edu   
Contact: Megan C Ichinose, PhD    (424) 229-1683    michinose@mednet.ucla.edu   
Principal Investigator: David J Miklowitz, PhD         
Sub-Investigator: Danielle M Denenny, PhD         
Sub-Investigator: Jennifer M Gamarra, PhD         
Sub-Investigator: Elizabeth A Horstmann, MD         
Sub-Investigator: Megan C Ichinose, PhD         
Sub-Investigator: Sarah E Marvin, PhD         
Sub-Investigator: Robert L Suddath, MD         
Sub-Investigator: Patricia D Walshaw         
Sub-Investigator: Marc J Weintraub, PhD         
United States, Colorado
University of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression Center Enrolling by invitation
Aurora, Colorado, United States, 80045
United States, Pennsylvania
University of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS) Enrolling by invitation
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
Virginia Commonwealth University Medical Center Enrolling by invitation
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
University of California, Los Angeles
University of Pittsburgh
Virginia Commonwealth University
University of Colorado, Denver
Investigators
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Principal Investigator: David J Miklowitz, PhD University of California, Los Angeles
  Study Documents (Full-Text)

Documents provided by David J. Miklowitz, Ph.D., University of California, Los Angeles:
Study Protocol  [PDF] March 1, 2022

Additional Information:
Publications:

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Responsible Party: David J. Miklowitz, Ph.D., Distinguished Professor of Psychiatry, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT05427123    
Other Study ID Numbers: IRB#22-000309
First Posted: June 22, 2022    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David J. Miklowitz, Ph.D., University of California, Los Angeles:
medication
psychosocial
treatment
longitudinal
naturalistic
assessment
Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Mental Disorders
Neurodevelopmental Disorders
Bipolar and Related Disorders
Pathologic Processes