Clinical trial NCT02355366: Family Focused Therapy for Teens at Risk for Bipolar Disorder
Official title: Family Focused Therapy (FFT) for Adolescents at Familial Risk for Bipolar
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Offspring
significant mood symptoms
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 2
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study aims to examine the effects of a 4 month, family focused therapy (FFT) intervention on the 1 year course of mood symptoms in offspring of parents with bipolar disorder (BD). The study will also examine the level of expressed emotion among families and how this impacts on FFT treatment outcomes. This study seeks to replicate a previous study by Miklowitz, Schneck, Singh, Taylor, George and colleagues (2013), which demonstrated the efficacy of FFT among BD offspring. Importantly, the present study will introduce biological measures that predict and reflect improvement in symptoms and expressed emotion. These markers reflect stress-related biological systems and include saliva samples to ascertain cortisol, interleukin-6 (IL-6) and salivary alpha amylase (sAA).

Detailed description: Children of parents with bipolar disorder (BD) have increased risk of developing BD themselves. BD in youth is associated with increased risk for suicidality, psychosis, substance abuse and compromised psychosocial functioning. In addition, offspring of parents with BD have an increased vulnerability for developing other psychopathology (e.g. major depression). At present, research examining early intervention and treatment for this high risk population is limited. However, a recent study in symptomatic youth at risk for BD indicated that participation in a family focused therapy (FFT) intervention led to positive treatment outcomes. The present study aims to examine the effects of FFT in BD offspring in comparison to a brief educational treatment. Specifically, this study will examine whether FFT can have protective effects on individuals' mood symptoms and functioning by targeting the family environment. We will expand upon previous research by also measuring biological markers of stress (i.e., cortisol levels) and changes in family functioning over time. With this knowledge, the results of this study may help to shed light on the importance of early intervention and improve preventative treatment options for youth at high-risk for bipolar disorder.

Eligibility criteria: Inclusion Criteria:

1. English-speaking males and females of any race/ethnicity
2. 13-19 years of age
3. Have at least 1 biological parent who meets diagnostic criteria for bipolar disorder (BD) type I or II, based on the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)
4. Adolescent is experiencing current, significant mood symptoms indicated by a psychiatric status rating (PSR) score of 3
5. At least 1 parent/primary caregiver is available to attend sessions.

All participants will complete rigorous diagnostic interviews to ensure that they meet these requirements.

Exclusion Criteria:

1. Unable to provide informed consent (e.g., severe psychosis, developmental delay)
2. Have met the DSM-IV criteria (based on the Schedule for Affective Disorders and Schizophrenia for School Age Children, Present and Life Version - K-SADS-PL), for substance dependence in the past 3 months (excluding nicotine dependence)
3. Are victims of current sexual or physical abuse by parents or live among domestic violence
4. For offspring, already meet criteria for bipolar disorder (BD) type I or II.

Primary outcomes:
measure: KSADS Mania Rating Scale (KMRS)
timeFrame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
measure: KSADS Depression Section (KDRS)
timeFrame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
measure: Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE)
timeFrame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
measure: The Family Environment Scale (FES)
timeFrame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
measure: Family Adaptability & Cohesion & Adaptability Scale (FACES)
timeFrame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
measure: Conflict Behaviour Questionnaire (CBQ)
timeFrame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
measure: Issues Checklist
timeFrame: Change from baseline to endpoint (assessed at 0, 4 and 12 months)
measure: Cortisol
timeFrame: Change from baseline to endpoint (assessed at 0, 4, and 12 months)
measure: Interleukin 6 (IL-6)
timeFrame: Change from baseline to endpoint (assessed at weeks 0, 4, and 12 months)
measure: Alpha Amylase
timeFrame: Change from baseline to endpoint (assessed at 0, 4, and 12 months)
measure: Five Minute Speech Sample
timeFrame: Change from baseline to endpoint (assessed at 0, 4, and 12 months)
measure: Emotional Response to Conflict Scale (ERCS)
timeFrame: Change from baseline to endpoint (assessed at 0, 4 and 12 months)
Secondary outcomes:
measure: Children Global Assessment Scale
timeFrame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
measure: Anthromorphic Data
timeFrame: Change from baseline to endpoint (Assessed at weeks 0 and 12 months)
measure: Working Alliance Inventory Short-Revised (WAI-SR)
timeFrame: Change from baseline to endpoint. For FFT Group: Assessed after therapy sessions 1, 4, 8 & 12. For Education Control Group: Assessed after therapy sessions 1 & 2.
measure: General Information Sheet
timeFrame: Baseline
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Benjamin Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: Miklowitz DJ. Family-focused treatment for children and adolescents with bipolar disorder. Isr J Psychiatry Relat Sci. 2012;49(2):95-101.