Trial record 2 of 2 for:    Open Studies | "Cyclothymic Disorder"

Early Intervention for Youth at Risk for Bipolar Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of California, Los Angeles
Sponsor:
Collaborators:
Stanford University
University of Colorado, Boulder
Information provided by (Responsible Party):
David J. Miklowitz, Ph.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01483391
First received: November 26, 2011
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

Children or teens with mood swings or depression who have a parent with bipolar disorder are at high risk for developing bipolar disorder themselves. This study will test a family-based therapy aimed at preventing or reducing the early symptoms of bipolar disorder in high-risk children (ages 9-17). In a randomized trial, the investigators will compare two kinds of family-based treatment (one more and one less intensive) on the course of early mood symptoms and social functioning among high-risk children followed for up to 4 years. The investigators will examine the effects of family treatment on measures of neural activation using functional magnetic resonance imaging.


Condition Intervention Phase
Bipolar Disorder
Major Depressive Disorder
Behavioral: Enhanced Care
Behavioral: Family-Focused Treatment
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early Intervention for Youth at Risk for Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Changes in symptom severity [ Time Frame: Measured at baseline, every 4 months in year 1, and every 6 months in years 2-4 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Delaying onset of a first (hypo)manic or mixed episode [ Time Frame: 2-4 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 150
Study Start Date: October 2011
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Psychoeducation
  • Case Management
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.
Other Names:
  • Family Therapy
  • Family Psychoeducation
  • FFT
  • Family Intervention
  • Psychoeducation
  • Family Treatment

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   9 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483391

Contacts
Contact: David J Miklowitz, Ph.D. 310-267-2659 dmiklowitz@mednet.ucla.edu
Contact: Brittany Matkevich 310-825-2836 bscott@mednet.ucla.edu

Locations
United States, California
UCLA Child and Adolescent Mood Disorders Program, UCLA School of Medicine Recruiting
Los Angeles, California, United States, 90024-1759
Contact: David J Miklowitz, PhD    310-267-2659    dmiklowitz@mednet.ucla.edu   
Contact: Brittany S Matkevich    310-825-2836    bscott@mednet.ucla.edu   
Principal Investigator: David J Miklowitz, PhD         
Stanford University School of Medicine, Lucile Packard Children's Hospital Recruiting
Stanford, California, United States, 94304
Contact: Kiki D Chang, MD    650-725-0956    kchang88@stanford.edu   
Contact: Jennifer Pearlstein    650-725-6760    jpearlst@stanford.edu   
Principal Investigator: Kiki D Chang, MD         
United States, Colorado
University of Colorado, Boulder Recruiting
Boulder, Colorado, United States, 80309
Contact: Zachary Millman, MA    303-492-1668    zachary.millman@colorado.edu   
Contact: Christopher D Schneck, MD    303-724-3300    christopher.schneck@ucdenver.edu   
Principal Investigator: Christopher D Schneck, MD         
Sponsors and Collaborators
University of California, Los Angeles
Stanford University
University of Colorado, Boulder
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: David J. Miklowitz, Ph.D., Professor of Psychiatry, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01483391     History of Changes
Other Study ID Numbers: R01MH093676
Study First Received: November 26, 2011
Last Updated: February 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Bipolar disorder
Major depressive disorder
Mania
Depression
Cyclothymic Disorder

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Bipolar Disorder
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Affective Disorders, Psychotic

ClinicalTrials.gov processed this record on September 18, 2014