Children's Bipolar Network Treatment Trial I for Bipolar Spectrum Disorders
This observational study, called the Children's Bipolar Network Treatment Trial I, is looking at youth aged 9 to 19 who have bipolar disorder (Bipolar I, Bipolar II, or Other Specified Bipolar and Related Disorder) or mood instability. The study aims to better identify and diagnose these conditions, and to understand what factors predict how well youth respond to treatment over a 12-month period. Participants will receive medication management or psychosocial treatment from study psychiatrists, following best practice guidelines. Researchers will measure changes in psychiatric status, mood swings (affective lability), and family conflict to see if treatments are successful.
- Study design
- This is an observational study with a planned enrollment of 80 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would complete a screening diagnostic interview and have a baseline blood draw. You would also have assessments at 0, 6, and 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after starting the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Children's Bipolar Network Treatment Trial I
At a glance
Conditions
Where it's being run
4 sites across 4 statesStudy leadership
- David J Miklowitz, PhD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE) Psychiatric Status RatingsThe 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 formsThe 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 formsThe 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 formsThe 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.