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

This study has been completed.
Sponsor:
Collaborator:
University of Colorado, Boulder
Information provided by (Responsible Party):
David J. Miklowitz, Ph.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00571402
First received: December 11, 2007
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

This study will evaluate the effectiveness of family-focused psychoeducational treatment along with medication in treating adolescents with bipolar I disorder.


Condition Intervention Phase
Bipolar Disorder
Behavioral: Family-focused therapy for adolescents
Behavioral: Enhanced care
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Family-Focused Psychoeducation for Bipolar Adolescents

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Adolescent Longitudinal Interval Follow-up Examination [ Time Frame: Measured at baseline and Months 3, 6, 9, and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Kiddie Schedule for Affective Disorders and Schizophrenia [ Time Frame: Measured at baseline and Months 3, 6, 9, and 12 ] [ Designated as safety issue: Yes ]
  • Depression and Mania Rating Scales [ Time Frame: Measured at baseline and Months 3, 6, 9, and 12 ] [ Designated as safety issue: Yes ]

Enrollment: 58
Study Start Date: July 2001
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FFT
Family-focused therapy (FFT) and pharmacotherapy for adolescents, a 21 session family psychoeducational interventio0n administered with best practice medication treatment
Behavioral: Family-focused therapy for adolescents
FFT includes 25 sessions of psychoeducation, communication enhancement training, and problem-solving skills training plus ongoing pharmacological maintenance.
Other Name: FFT-A
Active Comparator: Echanced Care
Enhanced care (EC) and pharmacotherapy for adolescents
Behavioral: Enhanced care
Enhanced care includes 3 sessions of family psychoeducation plus ongoing pharmacological maintenance.
Other Name: Treatment as usual (TAU)

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571402

Locations
United States, Colorado
Department of Psychology, University of Colorado
Boulder, Colorado, United States, 80309-0345
United States, Pennsylvania
Child and Adolescent Bipolar Services Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of California, Los Angeles
University of Colorado, Boulder
Investigators
Principal Investigator: David J. Miklowitz, PhD University of Colorado at Boulder
Principal Investigator: David A. Axelson, MD University of Pittsburgh
  More Information

Additional Information:
Publications:
Responsible Party: David J. Miklowitz, Ph.D., Professor of Psychiatry, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00571402     History of Changes
Other Study ID Numbers: R21 MH62555, R21MH062555, DSIR CT-S
Study First Received: December 11, 2007
Last Updated: March 24, 2014
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
Family Treatment
Pharmacotherapy

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014