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Evaluating the Effectiveness of Family-Focused Psychoeducation in Treating Adolescents With Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Family-focused therapy for adolescents
Enhanced care
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Family Treatment, Pharmacotherapy

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meets DSM-IV criteria for bipolar I, bipolar II, or not otherwise specified (NOS) disorder based on independent Kiddie Schedule for Affective Disorders and Schizophrenia and on present and lifetime version interviews with the patient and at least one parent
  • Concurrent physician diagnosis of bipolar I, II, or NOS disorder based on a separate set of evaluations of the parent and child
  • At least a 1-week episode of manic, mixed, or hypomanic symptoms or a 2-week episode of depressive symptoms within the 3 months prior to study entry
  • Currently taking or willing to proceed with regular pharmacotherapy from a study psychiatrist
  • At least one biological parent or step-parent with whom the patient lives who is willing to participate in treatment

Exclusion Criteria:

  • History of severe, unremitting psychosis lasting more than 3 months
  • Evidence of mental retardation (IQ less than 70), organic central nervous system (CNS) disorder, or pervasive developmental disorder
  • Substance or alcohol dependence or abuse disorders in the 3 months prior to study entry
  • Current life-threatening eating disorder or medical disorder

Sites / Locations

  • Department of Psychology, University of Colorado
  • Child and Adolescent Bipolar Services Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FFT

Echanced Care

Arm Description

Family-focused therapy (FFT) and pharmacotherapy for adolescents, a 21 session family psychoeducational interventio0n administered with best practice medication treatment

Enhanced care (EC) and pharmacotherapy for adolescents

Outcomes

Primary Outcome Measures

Adolescent Longitudinal Interval Follow-up Examination

Secondary Outcome Measures

Kiddie Schedule for Affective Disorders and Schizophrenia
Depression and Mania Rating Scales

Full Information

First Posted
December 11, 2007
Last Updated
March 24, 2014
Sponsor
University of California, Los Angeles
Collaborators
University of Colorado, Boulder
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1. Study Identification

Unique Protocol Identification Number
NCT00571402
Brief Title
Evaluating the Effectiveness of Family-Focused Psychoeducation in Treating Adolescents With Bipolar Disorder
Official Title
Family-Focused Psychoeducation for Bipolar Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
University of Colorado, Boulder

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the effectiveness of family-focused psychoeducational treatment along with medication in treating adolescents with bipolar I disorder.
Detailed Description
Bipolar disorder, also called manic-depressive illness, is a brain disorder that causes dramatic changes in a person's mood and energy. People with bipolar disorder undergo periods of extreme happiness and extreme sadness, known as episodes of mania and depression. Early onset of bipolar disorder poses an especially high health risk to affected individuals. For example, adolescents with bipolar I disorder are at increased risk for hospitalizations, social and academic deterioration, suicide, substance abuse, and nonadherence to medications. Treatment-based research for bipolar adolescents has lagged behind research for adults, particularly in the psychosocial arena. Family-focused treatment (FFT), consisting of psychoeducation about bipolar disorder for the patient and relatives, communication enhancement training, and problem-solving training, has shown promise as an effective psychosocial model. In two previous studies, FFT was found to be a useful addition to bipolar medications in treating adult bipolar I disorder. This study will test the effectiveness of FFT that is centered upon the developmental needs of adolescents with bipolar I disorder. This study will be divided into three phases. In Phases I and II, adolescent participants and their parents will be enrolled into FFT sessions; the adolescents will also be treated with medications using a clinical management manual. The first two phases will be used to revise and perfect the FFT adolescent (FFT-A) focused manual to be used in the Phase III clinical trial portion of the study. Participation in Phase III will last about 2 years. All adolescent and parent participants in Phase III will first undergo research interviews. Child-only interviews will last 2 hours and will include questions about mood problems, problems with friends or family members, and substance use history. Parent-only interviews will be conducted in two 1-hour sessions and will include questions about their child's mood and behavioral problems, treatments, and how their child's problems have affected family life. Parent participants will also be asked to assist their child in filling out a questionnaire on mood and behavioral problems and to fill out a questionnaire concerning their own history of problems with mood or anxiety. The last of the initial research interviews will be conducted at the University of Colorado's Psychology Department. Parent and child participants, as well as other relatives, will be asked to talk about problems in family life and ways to solve them. Participants will also be asked to describe pictures from inkblot cards. Next, participants in Phase III will be divided into 1 of 2 treatment groups: FFT-A plus standard bipolar medication or treatment as usual (TAU) plus standard bipolar medication. There will be a total of 25 FFT sessions over a 2-year period. The sessions will occur weekly for 12 weeks, every other week for the next 12 weeks, every month for 3 more months, and every 3 months for 1 more year. During FFT sessions, parent and adolescent participants will learn about mood disorders and ways to solve family problems. The sessions will be held at the Denver Children's Hospital, the University of Colorado Health Sciences Center's outpatient offices, or the University of Colorado's Psychology Department. Participants receiving TAU will be given an educational workbook on mood disorders and ways to cope with them as a family. TAU participants will attend three 3-hour family counseling sessions to explain the content of the workbook. The sessions will take place at the same locations as the FFT sessions. Child participants in both groups will take their prescribed medications for their bipolar disorder and will continue to see their psychiatrists on a regular basis. Repeat research interviews will occur every 3 months during the first year of the study and every 6 months during the second year of the study. Questionnaires will be distributed for children and their parents every 6 weeks during the first year of the study and every 3 months during the second year of the study. A questionnaire on the child's functioning in the school setting will also be sent to the child participant's school teacher every 3 months. Outcome assessments will be made at baseline and Months 3, 6, 9, and 12.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Family Treatment, Pharmacotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FFT
Arm Type
Experimental
Arm Description
Family-focused therapy (FFT) and pharmacotherapy for adolescents, a 21 session family psychoeducational interventio0n administered with best practice medication treatment
Arm Title
Echanced Care
Arm Type
Active Comparator
Arm Description
Enhanced care (EC) and pharmacotherapy for adolescents
Intervention Type
Behavioral
Intervention Name(s)
Family-focused therapy for adolescents
Other Intervention Name(s)
FFT-A
Intervention Description
FFT includes 25 sessions of psychoeducation, communication enhancement training, and problem-solving skills training plus ongoing pharmacological maintenance.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced care
Other Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
Enhanced care includes 3 sessions of family psychoeducation plus ongoing pharmacological maintenance.
Primary Outcome Measure Information:
Title
Adolescent Longitudinal Interval Follow-up Examination
Time Frame
Measured at baseline and Months 3, 6, 9, and 12
Secondary Outcome Measure Information:
Title
Kiddie Schedule for Affective Disorders and Schizophrenia
Time Frame
Measured at baseline and Months 3, 6, 9, and 12
Title
Depression and Mania Rating Scales
Time Frame
Measured at baseline and Months 3, 6, 9, and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets DSM-IV criteria for bipolar I, bipolar II, or not otherwise specified (NOS) disorder based on independent Kiddie Schedule for Affective Disorders and Schizophrenia and on present and lifetime version interviews with the patient and at least one parent Concurrent physician diagnosis of bipolar I, II, or NOS disorder based on a separate set of evaluations of the parent and child At least a 1-week episode of manic, mixed, or hypomanic symptoms or a 2-week episode of depressive symptoms within the 3 months prior to study entry Currently taking or willing to proceed with regular pharmacotherapy from a study psychiatrist At least one biological parent or step-parent with whom the patient lives who is willing to participate in treatment Exclusion Criteria: History of severe, unremitting psychosis lasting more than 3 months Evidence of mental retardation (IQ less than 70), organic central nervous system (CNS) disorder, or pervasive developmental disorder Substance or alcohol dependence or abuse disorders in the 3 months prior to study entry Current life-threatening eating disorder or medical disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J. Miklowitz, PhD
Organizational Affiliation
University of Colorado at Boulder
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David A. Axelson, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychology, University of Colorado
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309-0345
Country
United States
Facility Name
Child and Adolescent Bipolar Services Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15571785
Citation
Miklowitz DJ, George EL, Axelson DA, Kim EY, Birmaher B, Schneck C, Beresford C, Craighead WE, Brent DA. Family-focused treatment for adolescents with bipolar disorder. J Affect Disord. 2004 Oct;82 Suppl 1(Suppl 1):S113-28. doi: 10.1016/j.jad.2004.05.020.
Results Reference
background
PubMed Identifier
17064437
Citation
Miklowitz DJ, Biuckians A, Richards JA. Early-onset bipolar disorder: a family treatment perspective. Dev Psychopathol. 2006 Fall;18(4):1247-65. doi: 10.1017/S0954579406060603.
Results Reference
background
PubMed Identifier
18762591
Citation
Miklowitz DJ, Axelson DA, Birmaher B, George EL, Taylor DO, Schneck CD, Beresford CA, Dickinson LM, Craighead WE, Brent DA. Family-focused treatment for adolescents with bipolar disorder: results of a 2-year randomized trial. Arch Gen Psychiatry. 2008 Sep;65(9):1053-61. doi: 10.1001/archpsyc.65.9.1053.
Results Reference
result
PubMed Identifier
19454920
Citation
Miklowitz DJ, Axelson DA, George EL, Taylor DO, Schneck CD, Sullivan AE, Dickinson LM, Birmaher B. Expressed emotion moderates the effects of family-focused treatment for bipolar adolescents. J Am Acad Child Adolesc Psychiatry. 2009 Jun;48(6):643-651. doi: 10.1097/CHI.0b013e3181a0ab9d.
Results Reference
result

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Evaluating the Effectiveness of Family-Focused Psychoeducation in Treating Adolescents With Bipolar Disorder

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