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

Bipolar Disorder Clinical Trial

Official title:

Family-Focused Psychoeducation for Bipolar Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571402
• Other study ID #: R21MH062555
• Secondary ID: R21MH062555DSIR
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 11, 2007
• Last updated: March 24, 2014
• Start date: July 2001
• Est. completion date: September 2005

Study information

• Verified date: March 2014
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• Family-focused therapy for adolescents
FFT includes 25 sessions of psychoeducation, communication enhancement training, and problem-solving skills training plus ongoing pharmacological maintenance.
• Enhanced care
Enhanced care includes 3 sessions of family psychoeducation plus ongoing pharmacological maintenance.

Locations

Country	Name	City	State
United States	Department of Psychology, University of Colorado	Boulder	Colorado
United States	Child and Adolescent Bipolar Services Clinic	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 — View 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):643-51. doi: — View Citation

Miklowitz DJ, Biuckians A, Richards JA. Early-onset bipolar disorder: a family treatment perspective. Dev Psychopathol. 2006 Fall;18(4):1247-65. Review. — View 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:S113-28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adolescent Longitudinal Interval Follow-up Examination		Measured at baseline and Months 3, 6, 9, and 12	No
Secondary	Kiddie Schedule for Affective Disorders and Schizophrenia		Measured at baseline and Months 3, 6, 9, and 12	Yes
Secondary	Depression and Mania Rating Scales		Measured at baseline and Months 3, 6, 9, and 12	Yes

External Links

•   Click here for more information on family-focused psychoeducation for bipolar adolescents on the Principal Investigator's Web site