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

NCT00571402 | Completed Phase 1 DMC

• 2 other identifiers: R21MH062555DSIR CT-S
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Bipolar Disorder

Keywords

Family Treatment; Pharmacotherapy

Outcome Measures

Primary Outcomes (1)

• Adolescent Longitudinal Interval Follow-up Examination

  Measured at baseline and Months 3, 6, 9, and 12

Secondary Outcomes (2)

• Kiddie Schedule for Affective Disorders and Schizophrenia

  Measured at baseline and Months 3, 6, 9, and 12

• Depression and Mania Rating Scales

  Measured at baseline and Months 3, 6, 9, and 12

Study Arms (2)

FFT

EXPERIMENTAL

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

Echanced Care

ACTIVE COMPARATOR

Enhanced care (EC) and pharmacotherapy for adolescents

Behavioral: Enhanced care

Interventions

Family-focused therapy for adolescents BEHAVIORAL

FFT includes 25 sessions of psychoeducation, communication enhancement training, and problem-solving skills training plus ongoing pharmacological maintenance.

Also known as: FFT-A

FFT

Enhanced care BEHAVIORAL

Enhanced care includes 3 sessions of family psychoeducation plus ongoing pharmacological maintenance.

Also known as: Treatment as usual (TAU)

Echanced Care

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of Colorado, Boulder: collaborator

Study Sites (2)

Department of Psychology, University of Colorado

Boulder, Colorado, 80309-0345, United States

Location

Child and Adolescent Bipolar Services Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

• 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.

  PMID: 15571785 BACKGROUND

• 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.

  PMID: 17064437 BACKGROUND

• 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.

  PMID: 18762591 RESULT

• 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.

  PMID: 19454920 RESULT

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• David J. Miklowitz, PhD

  University of Colorado at Boulder

  PRINCIPAL INVESTIGATOR

• David A. Axelson, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 12, 2007
• Study Start: July 1, 2001
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

US (2)