Early Intervention for Youth at Risk for Bipolar Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01483391|
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : October 4, 2021
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Major Depressive Disorder||Behavioral: Enhanced Care Behavioral: Family-Focused Treatment||Not Applicable|
Children who are at high risk for developing bipolar disorder (BD) often are showing significant mood swings or depression well before they develop the full disorder. Often, these children have one or more parents who have bipolar disorder. In addition to brief episodes of lethargic depression and mania or hypomania (periods of excessive activity), children and adolescents at risk for BD often have co-occurring disorders, such as attention deficit hyperactivity disorder, conduct disorder, substance abuse disorders, and anxiety disorders.
Early interventions may lead to better mental health by preventing BD from ever fully expressing itself. This study will test an early intervention for BD called family-focused treatment (FFT), which has been designed to help children and adolescents who are at risk for developing BD. FFT will combine education about BD with training in communication strategies and problem-solving skills. It will focus on the family, because family environmental factors are related to the course and recurrence of BD. By reducing risk factors and teaching coping skills, FFT aims to reduce the early symptoms of BD, improve functioning, and delay the onset or reduce the severity of manic episodes.
Participation in this study will last up to 4 years, although the majority of the study will occur in the first year. There are three parts. In the first part, participating children and their families will complete research interviews and questionnaires about the child's mood, behavior, beliefs, and problems. Parent participants will provide information on the family background of mood or anxiety problems. All participants will receive a thorough medical-psychiatric evaluation and be provided with pharmacotherapy (as needed) from a study psychiatrist for the first year of the study.
In the second part, participants will be randomly assigned to receive one of two treatments: FFT or enhanced care. Participants receiving FFT will complete 12 therapy sessions in which parents, children, and siblings learn how to cope with mood disorders, new ways to talk to each other, and strategies for solving family problems. FFT sessions will occur weekly for the first 8 weeks and then every other week for the next 8 weeks. Participants receiving enhanced care will have 3 weekly sessions which will involve the youth and all family members. In session 1, clinicians summarize the diagnostic assessment, introduce mood charting, and offer instructional handouts on managing mood swings. In session 2, clinicians revisit mood charting, discuss medications (if relevant), and help the child and family develop a mood management plan. In session 3, families rehearse mood regulation strategies for current family, social or academic problems. Clinicians then meet with the child individually every month for the next 3 mos. to provide support, assist with problem-solving, and troubleshoot use of the mood management plan. So, both treatments last 4 months.
In the third part of the study, participants will complete follow-up assessments every 4 months for 1 year. Assessments will include interviews and questionnaires similar to those completed in the first part of the study.
The statistical analyses for this study will examine changes in symptoms and functioning from the baseline assessment through the 4 month follow-ups in year 1 and the 6 month follow-ups in years 2-4.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Early Intervention for Youth at Risk for Bipolar Disorder|
|Actual Study Start Date :||October 6, 2011|
|Actual Primary Completion Date :||September 15, 2016|
|Actual Study Completion Date :||September 15, 2020|
Active Comparator: Enhanced Care
Three sessions of family education and three sessions of individual support over 4 months.
Behavioral: Enhanced Care
The 3 family sessions involve the youth and all family members. These sessions will help the child and family members with mood charting and developing a mood management plan. Families will rehearse mood regulation strategies for current family, social or academic problems. Clinicians then meet with the child individually every month for the next 3 mos. to provide support, assist with problem-solving, and troubleshoot use of the mood management plan.
Experimental: Family-Focused Treatment
12 therapy sessions involving the at-risk child or adolescent, parents, and available siblings. Therapy will include psychoeducation about mood disorders, communication enhancement training, and problem-solving skills training.
Behavioral: Family-Focused Treatment
12 therapy sessions involving the at-risk child or adolescent, parents, and available siblings. Therapy will include psychoeducation about mood disorders, communication enhancement training, and problem-solving skills training. The goal of this intervention is to improve the child's ability to regulate moods and to reduce tension and conflict in the family.
- Changes in symptom severity [ Time Frame: Measured at baseline, every 4 months in year 1, and every 6 months in years 2-4 ]Changes in symptoms of at-risk children, as defined by depression and (hypo)mania scores and psychiatric status on the Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE, the Child Depression Rating Scale, and the Young Mania Rating Scale
- Delaying onset of a first (hypo)manic or mixed episode [ Time Frame: 2-4 years ]We will evaluate through survival analyses whether family-focused treatment, due to its ameliorative effects on acute symptoms, is superior to enhanced care in delaying onset of a first (hypo)manic or mixed episode during the 2-4 year follow-up.
- Psychosocial functioning [ Time Frame: Measured at baseline, every 4 months in year 1 and every 6 months in years 2-4 ]Youths in family-focused treatment will show greater improvement from pretreatment to end of a 2-4 year follow-up in psychosocial functioning compared to youth in Enhanced Care.
- Mental health service use [ Time Frame: Measured at baseline, every 4 months in year 1 and every 6 months in years 2-4 ]Youth in family-focused treatment will require fewer mental health services from pretreatment to end of a 2-4 year follow-up than youth in enhanced care
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||9 Years to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
For a child to be eligible:
- At least one biological parent or stepparent with whom the child or adolescent lives must be willing to participate in family treatment
- At least one biological parent has a verifiable diagnosis of bipolar disorder I or II
- The child must have a DSM-IV diagnosis of bipolar disorder not otherwise specified or major depressive disorder (MDD)
- If the main diagnosis is MDD, the depressive episode must have occurred within the past 2 years
- The child must have evidence of current significant affective symptoms, as determined by a score greater than 11 on the Young Mania Rating Scale within the last week or a score greater than 29 on the Child Depression Rating Scale-Revised within the last 2 weeks
- The family must speak English, although English need not be their first language
- Fully diagnosable bipolar disorder I or II
- Diagnosis of autism or pervasive developmental disorder
- Evidence of mental retardation, as defined by an intelligence quotient (IQ) less than 70
- Presence of comorbid neurologic diseases such as seizure disorder
- Substance or alcohol abuse or dependence disorders in the 4 months prior to study recruitment
- Evidence of a life-threatening eating disorder or other medical disorder that requires emergency medical treatment
- Currently enrolled in regular family therapy
- Evidence of current sexual or physical abuse or domestic abuse between the adult partners
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483391
|United States, California|
|UCLA Child and Adolescent Mood Disorders Program, UCLA School of Medicine|
|Los Angeles, California, United States, 90024-1759|
|Stanford University School of Medicine, Lucile Packard Children's Hospital|
|Stanford, California, United States, 94304|
|United States, Colorado|
|University of Colorado, Boulder|
|Boulder, Colorado, United States, 80309|
|Principal Investigator:||David J Miklowitz, PhD||UCLA Department of Psychiatry|
|Principal Investigator:||Kiki D Chang, MD||Stanford University|
|Principal Investigator:||Christopher D Schneck, MD||University of Colorado, Denver|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||David J. Miklowitz, Ph.D., Professor of Psychiatry, University of California, Los Angeles|
|Other Study ID Numbers:||
R01MH093676 ( U.S. NIH Grant/Contract )
|First Posted:||December 1, 2011 Key Record Dates|
|Last Update Posted:||October 4, 2021|
|Last Verified:||September 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Upon completing the study we will submit a CD-ROM to the NIH Freedom of Information Act Coordinator containing all raw data, variable coding information, and copies of measures. Prior to archiving the data, we will remove all personal identifiers and other protected information. The youth's and parents' consent forms will make clear that the data, minus any identifying information, will be made available to other researchers at the end of the study.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Major depressive disorder
Depressive Disorder, Major
Bipolar and Related Disorders