Bipolar Disorder Clinical Trial
Official title:
Technology-Enhanced Family-Focused Treatment for Adolescents at High Risk for Mood Disorders
Verified date | October 2022 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators propose to enhance the scalability of family-focused therapy (FFT), a 12-session evidence-based therapy for youth at high risk for mood disorders, through augmentation with a novel mobile phone application called MyCoachConnect (MCC). In adolescents with mood instability who have a parent with bipolar or major depressive disorder, clinicians in community clinics will conduct FFT sessions (consisting of psychoeducation and family skills training) supplemented by weekly MCC "real time" assessments of moods and family relationships; based on results of these assessments and the family's progress in treatment, clinicians will then push personalized informational and coaching alerts regarding the practice of communication and problem-solving skills. The investigators hypothesize that the augmented version of FFT (FFT-MCC) will be more effective than FFT without coaching/informational alerts in altering treatment targets and in stabilizing youths' mood symptoms and quality of life.
Status | Completed |
Enrollment | 65 |
Est. completion date | October 20, 2021 |
Est. primary completion date | October 20, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 19 Years |
Eligibility | Inclusion Criteria: - English speaking and has access to smart-phones, a tablet, or computer - Age 13-19 years old - One parent with diagnosis of bipolar disorder type I, bipolar disorder type II, or - major depressive disorder. - At least one parent is rated high in perceived criticism of the child. - Child shows evidence of mood instability - Child is not currently in individual therapy. Exclusion Criteria: - Over 6 on the Autism Spectrum Disorder screener - a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition manic episode of bipolar I disorder has occurred in the past 2 weeks - history of persistent psychotic symptoms that have not remitted when mood states remit. - intelligence quotient below 70 from school records - Any significant and persistent substance or alcohol abuse in the prior 3 months - Previously received a full course (i.e., 10-12 sessions) of FFT - Current, active sexual abuse, physical abuse, or domestic violence. |
Country | Name | City | State |
---|---|---|---|
United States | UCLA Child and Adolescent Mood Disorders Program, UCLA School of Medicine | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | National Institute of Mental Health (NIMH) |
United States,
Miklowitz DJ, Chung B. Family-Focused Therapy for Bipolar Disorder: Reflections on 30 Years of Research. Fam Process. 2016 Sep;55(3):483-99. doi: 10.1111/famp.12237. Epub 2016 Jul 29. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average mood symptom scores over 27 weeks on the Adolescent Longitudinal Interval Follow-up Evaluation | Adolescent Longitudinal Interval Followup Evaluation (ALIFE), a measure of mood disorder fluctuation based on an interview with the child and at least one parent. ALIFE Psychiatric Status Ratings range from 1 (asymptomatic) to 6 (extremely symptomatic) and are made weekly for depression, mania, hypomania, delusions, hallucinations, and suicidal ideation. Scores of 5 or higher are considered full syndromal (e.g., for major depressive disorder or manic episode) and scores of 1-2 are considered remitted. | 27 weeks, with ratings done by an independent evaluator each week | |
Secondary | Mood instability, as rated by parents and children using the Children's Affective Lability Scale (CALS) and the Parent-Rated General Behavior Inventory | Changes in mood states from sadness to irritability to elation or other moods. The CALS is a 20-item survey completed by parents. In this study, a score of 20 will be used to indicate high mood instability. Parent ratings on the Parent General Behavior Inventory, 10 item Mania scale will be made at study entry, with a score of 6 or higher indicating mood instability. | Mean Children's Affective Lability scores computed at baseline and every 9 weeks for 27 weeks | |
Secondary | Expressed emotion in parents from the Five Minute Speech Sample | Parental expressed emotion is a measure of critical comments, hostility, or emotional overinvolvement. The primary instrument in this study is the Five Minute Speech Sample, which is scored by an independent evaluator on number of criticisms, presence/absence of hostility, or overinvolvement. One critical comment or a rating of present for hostility or overinvolvement means the parent is rated high in expressed emotion, and low expressed emotion otherwise. Expressed emotion is also measured by the Perceived Criticism Scale, a 1-10 measure of how often the child thinks each parent criticizes him/her. A rating of '5' is considered high and indicative of a high EE parent/offspring relationship. | Ratings of high vs. low expressed emotion in each parent obtained at baseline and every 9 weeks for 27 weeks. | |
Secondary | Free speech samples coded using the Linguistic Inquiry Word Count system. | Callers are asked to speak for 3-5 minutes about how they are doing and whether anything has gone well or whether they have had difficulties. The samples will be transcribed and coded via the Linguistic Inquiry Word Count. The goal is to measure whether mood instability and expressed emotion can be captured from weekly free speech call-ins by parents or youth. | weekly call-ins, with linguistic counts of negative or positive words tabulated each week for 27 weeks. |
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