Children's Bipolar Network Treatment Trial I

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Change in Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE) Psychiatric Status Ratings [Срок оценки: The measure will be administered at 0, 6, and 12 months.]
• Change in Children's Affective Lability Scale (CALS), Child and Parent Report forms [Срок оценки: The measure will be administered at 0, 6, and 12 months.]
• Change in Conflict Behavior Questionnaire (CBQ) scores, Child and Parent Report forms [Срок оценки: The measure will be administered at 0, 6, and 12 months.]
• Kiddo-KINDL Quality of Life Questionnaire for Children, Child and Parent Reports forms [Срок оценки: The measure will be administered at 0, 6, and 12 months.]

Вторичные конечные точки (7)

• Change in Parents' Online Weekly Evaluation and Rating Scale (POWERS), Parent Report form [Срок оценки: 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) [Срок оценки: The measure will be administered at 0, 6, and 12 months.]
• Change in Mood and Feelings Questionnaire (MFQ), Child and Parent Report forms [Срок оценки: The measure will be administered at 0, 6, and 12 months.]
• Change in Self-Report for Childhood Anxiety Related Disorders (SCARED), Child Report form [Срок оценки: The measure will be administered at 0, 6, and 12 months.]
• Drug Use Screening Inventory, Revised (DUSI-R), Child Report form [Срок оценки: The measure will be administered at 0, 6, and 12 months.]
• Change in Positive and Negative Affect Schedule for Children (PANAS-C-SF), Child Report Short form [Срок оценки: The measure will be administered at 0, 6, and 12 months.]
• Change in Perceived Criticism on Perceived Criticism Scale (PC), Child Report form [Срок оценки: The measure will be administered at 0, 6, and 12 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 4 центра

• University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Progra — Los Angeles
• University of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression Cen — Aurora
• University of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS) — Pittsburgh
• Virginia Commonwealth University Medical Center — Richmond

Публикации

• Birmaher B, Khetarpal S, Brent D, Cully M, Balach L, Kaufman J, Neer SM. The Screen for Child Anxiety Related Emotional Disorders (SCARED): scale construction and psychometric characteristics. J Am Acad Child Adolesc Psychiatry. 1997 Apr;36(4):545-53. doi: 10.1097/00004583-199704000-00018. PMID 9100430
• Birmaher B, Merranko JA, Goldstein TR, Gill MK, Goldstein BI, Hower H, Yen S, Hafeman D, Strober M, Diler RS, Axelson D, Ryan ND, Keller MB. A Risk Calculator to Predict the Individual Risk of Conversion From Subthreshold Bipolar Symptoms to Bipolar Disorder I or II in Youth. J Am Acad Child Adolesc Psychiatry. 2018 Oct;57(10):755-763.e4. doi: 10.1016/j.jaac.2018.05.023. Epub 2018 Aug 7. PMID 30274650
• Chang KD. Course and impact of bipolar disorder in young patients. J Clin Psychiatry. 2010 Feb;71(2):e05. doi: 10.4088/JCP.8125tx7c. PMID 20193644
• Costello EJ, Angold A. Scales to assess child and adolescent depression: checklists, screens, and nets. J Am Acad Child Adolesc Psychiatry. 1988 Nov;27(6):726-37. doi: 10.1097/00004583-198811000-00011. No abstract available. PMID 3058677
• Gerson AC, Gerring JP, Freund L, Joshi PT, Capozzoli J, Brady K, Denckla MB. The Children's Affective Lability Scale: a psychometric evaluation of reliability. Psychiatry Res. 1996 Dec 20;65(3):189-98. doi: 10.1016/s0165-1781(96)02851-x. PMID 9029668
• Goldstein BI, Birmaher B, Carlson GA, DelBello MP, Findling RL, Fristad M, Kowatch RA, Miklowitz DJ, Nery FG, Perez-Algorta G, Van Meter A, Zeni CP, Correll CU, Kim HW, Wozniak J, Chang KD, Hillegers M, Youngstrom EA. The International Society for Bipolar Disorders Task Force report on pediatric bipolar disorder: Knowledge to date and directions for future research. Bipolar Disord. 2017 Nov;19(7): PMID 28944987
• Goldstein TR, Birmaher B, Axelson D, Ryan ND, Strober MA, Gill MK, Valeri S, Chiappetta L, Leonard H, Hunt J, Bridge JA, Brent DA, Keller M. History of suicide attempts in pediatric bipolar disorder: factors associated with increased risk. Bipolar Disord. 2005 Dec;7(6):525-35. doi: 10.1111/j.1399-5618.2005.00263.x. PMID 16403178
• Ebesutani C, Okamura K, Higa-McMillan C, Chorpita BF. A psychometric analysis of the Positive and Negative Affect Schedule for Children-Parent Version in a school sample. Psychol Assess. 2011 Jun;23(2):406-16. doi: 10.1037/a0022057. PMID 21381834

Идентификаторы

NCT: NCT05427123 · IRB#22-000309

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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