Bipolar DisorderCBNNCT05427123
Children's Bipolar Network Treatment Trial I
An observational study of Bipolar Disorder and Bipolar I Disorder, run by University of California, Los Angeles at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 19 years
- Conditions the study is for
- Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder
- What is being tested?
- Medication or psychosocial treatment
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2022to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Enrolling by invitation
University of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression Center
Aurora, Colorado, 80045
- Recruiting
University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Program (CHAMP)
Los Angeles, California, 90024
David J Miklowitz, PhD, 310-267-2659, dmiklowitz@mednet.ucla.edu
Megan C Ichinose, PhD, (424) 229-1683, michinose@mednet.ucla.edu
- Enrolling by invitation
University of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS)
Pittsburgh, Pennsylvania, 15213
- Enrolling by invitation
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
About this study
Official title: A Collaborative Treatment Network for Youth With or at High Risk for Bipolar Disorder
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.
Read the 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.
- Conditions
- Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder, Other Specified Bipolar and Related Disorder, Mood Instability, Child Mental Disorder
- Being tested
- Medication or psychosocial treatment
- Keywords
- medication, psychosocial, treatment, longitudinal, naturalistic, assessment
- Medical subject headings
- Bipolar Disorder, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication or psychosocial treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Medication or psychosocial treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 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.
Measured: 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 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.
Measured: The measure will be administered at 0, 6, and 12 months.
Change in Mood and Feelings Questionnaire (MFQ), Child and Parent Report forms
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.
Measured: 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 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
Measured: The measure will be administered at 0, 6, and 12 months.
Drug Use Screening Inventory, Revised (DUSI-R), Child Report form
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.
Measured: 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
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.
Measured: The measure will be administered at 0, 6, and 12 months.
Change in Perceived Criticism on Perceived Criticism Scale (PC), Child Report form
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.
Measured: The measure will be administered at 0, 6, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Jul 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Virginia Commonwealth University, University of Colorado, Denver, Milken Institute, Baszucki Brain Research Fund
- Responsible party
- Principal investigator, David J. Miklowitz, Ph.D., University of California, Los Angeles
- Investigators
- David J Miklowitz, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427123
- Sponsor's protocol ID
- IRB#22-000309
- Acronym
- CBN
- Status last verified
- Feb 2026
- First submitted
- 18 Mar 2022
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 9100430Birmaher 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.
PubMed 30274650Chang KD. Course and impact of bipolar disorder in young patients. J Clin Psychiatry. 2010 Feb;71(2):e05. doi: 10.4088/JCP.8125tx7c.
PubMed 20193644Costello 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.
PubMed 3058677Gerson 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.
PubMed 9029668Goldstein 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):524-543. doi: 10.1111/bdi.12556. Epub 2017 Sep 25.
PubMed 28944987Goldstein 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.
PubMed 16403178Ebesutani 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.
PubMed 21381834Hafeman DM, Merranko J, Goldstein TR, Axelson D, Goldstein BI, Monk K, Hickey MB, Sakolsky D, Diler R, Iyengar S, Brent DA, Kupfer DJ, Kattan MW, Birmaher B. Assessment of a Person-Level Risk Calculator to Predict New-Onset Bipolar Spectrum Disorder in Youth at Familial Risk. JAMA Psychiatry. 2017 Aug 1;74(8):841-847. doi: 10.1001/jamapsychiatry.2017.1763.
PubMed 28678992Kaufman J, Birmaher B, Brent DA, Ryan ND, Rao U. K-SADS-PL. J Am Acad Child Adolesc Psychiatry. 2000 Oct;39(10):1208. doi: 10.1097/00004583-200010000-00002. No abstract available.
PubMed 11026169Keller MB, Lavori PW, Friedman B, Nielsen E, Endicott J, McDonald-Scott P, Andreasen NC. The Longitudinal Interval Follow-up Evaluation. A comprehensive method for assessing outcome in prospective longitudinal studies. Arch Gen Psychiatry. 1987 Jun;44(6):540-8. doi: 10.1001/archpsyc.1987.01800180050009.
PubMed 3579500Kowatch RA, Fristad M, Birmaher B, Wagner KD, Findling RL, Hellander M; Child Psychiatric Workgroup on Bipolar Disorder. Treatment guidelines for children and adolescents with bipolar disorder. J Am Acad Child Adolesc Psychiatry. 2005 Mar;44(3):213-35. doi: 10.1097/00004583-200503000-00006.
PubMed 15725966Hooley JM, Miklowitz DJ. Perceived Criticism in the Treatment of a High-Risk Adolescent. J Clin Psychol. 2017 May;73(5):570-578. doi: 10.1002/jclp.22454. Epub 2017 Jan 23.
PubMed 28112810Miklowitz DJ, Efthimiou O, Furukawa TA, Scott J, McLaren R, Geddes JR, Cipriani A. Adjunctive Psychotherapy for Bipolar Disorder: A Systematic Review and Component Network Meta-analysis. JAMA Psychiatry. 2021 Feb 1;78(2):141-150. doi: 10.1001/jamapsychiatry.2020.2993.
PubMed 33052390Miklowitz DJ, Merranko JA, Weintraub MJ, Walshaw PD, Singh MK, Chang KD, Schneck CD. Effects of family-focused therapy on suicidal ideation and behavior in youth at high risk for bipolar disorder. J Affect Disord. 2020 Oct 1;275:14-22. doi: 10.1016/j.jad.2020.06.015. Epub 2020 Jun 26.
PubMed 32658817
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Collaborative Treatment Network for Youth With or at High Risk for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT05427123
- Acronym / sponsor ID
- CBN / IRB#22-000309
- Conditions
- Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder, Other Specified Bipolar and Related Disorder, Mood Instability, Child Mental Disorder
- Keywords
- medication, psychosocial, treatment, longitudinal, naturalistic, assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Pittsburgh, Virginia Commonwealth University, University of Colorado, Denver, Milken Institute, Baszucki Brain Research Fund
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Youth with or at clinical high risk for Bipolar Spectrum Disorder | – | Other: Medication or psychosocial treatmentYouth 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) |
Who may qualify
- Ages
- 9 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication or psychosocial treatmentYouth 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. | Other | Youth with or at clinical high risk for Bipolar Spectrum Disorder |
Primary outcome
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.
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.
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.
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.
7 secondary outcomes
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.
Change in General Behavior Inventory, Parent Version Short form (P-GBI)
Time frame: The measure will be administered at 0, 6, and 12 months.
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.
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.
Drug Use Screening Inventory, Revised (DUSI-R), Child Report form
Time frame: 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
Time frame: The measure will be administered at 0, 6, and 12 months.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Background: PubMed 9100430Birmaher 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.
- Background: PubMed 30274650Birmaher 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.
- Background: PubMed 20193644Chang KD. Course and impact of bipolar disorder in young patients. J Clin Psychiatry. 2010 Feb;71(2):e05. doi: 10.4088/JCP.8125tx7c.
- Background: PubMed 3058677Costello 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.
- Background: PubMed 9029668Gerson 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.
- Background: PubMed 28944987Goldstein 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):524-543. doi: 10.1111/bdi.12556. Epub 2017 Sep 25.
- Background: PubMed 16403178Goldstein 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.
- Background: PubMed 21381834Ebesutani 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.
- Background: PubMed 28678992Hafeman DM, Merranko J, Goldstein TR, Axelson D, Goldstein BI, Monk K, Hickey MB, Sakolsky D, Diler R, Iyengar S, Brent DA, Kupfer DJ, Kattan MW, Birmaher B. Assessment of a Person-Level Risk Calculator to Predict New-Onset Bipolar Spectrum Disorder in Youth at Familial Risk. JAMA Psychiatry. 2017 Aug 1;74(8):841-847. doi: 10.1001/jamapsychiatry.2017.1763.
- Background: PubMed 11026169Kaufman J, Birmaher B, Brent DA, Ryan ND, Rao U. K-SADS-PL. J Am Acad Child Adolesc Psychiatry. 2000 Oct;39(10):1208. doi: 10.1097/00004583-200010000-00002. No abstract available.
- Background: PubMed 3579500Keller MB, Lavori PW, Friedman B, Nielsen E, Endicott J, McDonald-Scott P, Andreasen NC. The Longitudinal Interval Follow-up Evaluation. A comprehensive method for assessing outcome in prospective longitudinal studies. Arch Gen Psychiatry. 1987 Jun;44(6):540-8. doi: 10.1001/archpsyc.1987.01800180050009.
- Background: PubMed 15725966Kowatch RA, Fristad M, Birmaher B, Wagner KD, Findling RL, Hellander M; Child Psychiatric Workgroup on Bipolar Disorder. Treatment guidelines for children and adolescents with bipolar disorder. J Am Acad Child Adolesc Psychiatry. 2005 Mar;44(3):213-35. doi: 10.1097/00004583-200503000-00006.
- UCLA Max Gray Child and Adolescent Mood Disorders Program (CHAMP) Website in Los Angeles, CALink provided by the sponsor.
- Child and Adolescent Bipolar Spectrum Services (CABS) at Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center (UPMC) in Pittsburgh, PALink provided by the sponsor.
- Virginia Commonwealth University (VCU) Medical Center Cameron K. Gallagher Mental Health Resource Center Virginia Treatment Center for Children (VTCC)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David J Miklowitz, PhD principal investigator
University of California, Los Angeles
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Bipolar I Disorder, run by University of California, Los Angeles at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David J Miklowitz, PhD ((310) 267-2659, dmiklowitz@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05427123, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.