Clinical trial NCT00943085: Early Family-Focused Treatment for Youth at Risk for Bipolar Disorder
Official title: Family-Focused Therapy as Early Treatment for Youth at Risk for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Early Signs of Bipolar Disorder
High Risk Youth
Adolescence
Childhood
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-07-21
Enrollment: 52
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will test a family-based therapy aimed at preventing or reducing the symptoms of bipolar disorder in at-risk children.

Detailed description: Early-onset bipolar disorder (BD) is a chronic, recurrent disorder that starts before age 18. In addition to the debilitating effects of BD, which include episodes of lethargic depression and exhausting mania, children and adolescents with 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 targets children and adolescents who are at risk for developing BD. FFT will include education about BD and 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 prevent expression of BD, delay the onset or reduce the severity of manic episodes, and ensure that the first treatment received is appropriate.

Participation in this study will last 1 year and include 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 also provide information on the family background of mood or anxiety problems. In the second part, participants will be randomly assigned to receive one of two treatments: FFT or brief educational treatment. 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 brief educational treatment will complete diagnostic assessments and a 1-hour individualized feedback session, and they will be given a workbook about childhood mood disorders. A counselor will be available to all participants, in case of emergencies, for the full study year. All participants will also be provided with standard pharmacotherapy as needed. 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.

Eligibility criteria: Inclusion Criteria:

* Has at least one biological parent or stepparent with whom the child or adolescent participant lives and who is willing to participate in family treatment
* Has a DSM-IV diagnosis of at least one of the following within the past 2 years : bipolar disorder not otherwise specified (BD-NOS), major depressive disorder (MDD), or cyclothymia
* If the main diagnosis is MDD, the depressive episode must have occurred within the past 2 years
* Has 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
* Not currently enrolled in family or marital therapy
* Has at least one biological parent or sibling with a verifiable diagnosis of bipolar disorder I or II
* Speaks English

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
* Has previously been treated with family-focused therapy
* Evidence of current sexual or physical abuse or domestic abuse between the adult partners

Primary outcomes:
measure: Changes in symptoms and functioning of at-risk children, as defined by depression and mania scores and psychiatric status on the Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE)
timeFrame: Measured every 4 months for 1 year
Secondary outcomes:
measure: Delayed onset of first manic, mixed, or hypomanic episode, measured on the A-LIFE
timeFrame: Measured every 4 months for 1 year
measure: Scores on the Child Depression Rating Scale
timeFrame: Measured every 4 months for 1 year
measure: Scores on the Young Mania Rating Scale
timeFrame: Measured every 4 months for 1 year
measure: Parental mood and distress, as measured by the Beck Depression Inventory, Symptom Checklist
timeFrame: Measured every 4 months for 1 year
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine, Lucile Packard Children's Hospital
state: California
city: Boulder
country: United States
facility: University of Colorado, Boulder
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: David J. Miklowitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miklowitz DJ, Chang KD. Prevention of bipolar disorder in at-risk children: theoretical assumptions and empirical foundations. Dev Psychopathol. 2008 Summer;20(3):881-97. doi: 10.1017/S0954579408000424.
citation: Chang K, Howe M, Gallelli K, Miklowitz D. Prevention of pediatric bipolar disorder: integration of neurobiological and psychosocial processes. Ann N Y Acad Sci. 2006 Dec;1094:235-47. doi: 10.1196/annals.1376.026.
citation: Miklowitz DJ, Schneck CD, Singh MK, Taylor DO, George EL, Cosgrove VE, Howe ME, Dickinson LM, Garber J, Chang KD. Early intervention for symptomatic youth at risk for bipolar disorder: a randomized trial of family-focused therapy. J Am Acad Child Adolesc Psychiatry. 2013 Feb;52(2):121-31. doi: 10.1016/j.jaac.2012.10.007. Epub 2013 Jan 2.
citation: Schneck CD, Chang KD, Singh MK, DelBello MP, Miklowitz DJ. A Pharmacologic Algorithm for Youth Who Are at High Risk for Bipolar Disorder. J Child Adolesc Psychopharmacol. 2017 Nov;27(9):796-805. doi: 10.1089/cap.2017.0035. Epub 2017 Jul 21.