A Collaborative Treatment Network for Youth With or at High Risk for Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Change in Conflict Behavior Questionnaire (CBQ) scores, Child and Parent Report forms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Medication or psychosocial treatment (Other)
结局指标
主要结局
Change in Conflict Behavior Questionnaire (CBQ) scores, Child and Parent Report forms
时间窗: 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.
Change in Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE) Psychiatric Status Ratings
时间窗: 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.
Kiddo-KINDL Quality of Life Questionnaire for Children, Child and Parent Reports forms
时间窗: 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.
Change in Children's Affective Lability Scale (CALS), Child and Parent Report forms
时间窗: 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.
次要结局
- Change in Positive and Negative Affect Schedule for Children (PANAS-C-SF), Child Report Short form(The measure will be administered at 0, 6, and 12 months.)
- 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.)
- Change in Perceived Criticism on Perceived Criticism Scale (PC), Child Report form(The measure will be administered at 0, 6, and 12 months.)
研究者
David J. Miklowitz, Ph.D.
Distinguished Professor of Psychiatry
University of California, Los Angeles