Family Focused Therapy for Teens at Risk for Bipolar Disorder

Sunnybrook Health Sciences Centre2 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

Interventions

Family-Focused TherapyBEHAVIORAL

Family Focused Therapy is a manual-based, psycho-educational intervention which is designed to reduce intra-familial stress, conflict, and affective arousal by enhancing communication and problem solving skills among families who are affected by bipolar disorder (Miklowitz et al., 2013). It concentrates on skills relevant to managing the prodromal stages of bipolar disorder, such as mood monitoring, reducing family conflict, improving problem solving, stabilizing daily routines and regulating sleep/wake cycles (Miklowitz, 2012).

Brief Educational TreatmentBEHAVIORAL

Brief Educational Treatment will consist of 1 - 2 sessions involving both parents and adolescents; it will consist of diagnostic feedback following the adolescent's baseline assessment. It will provide families with information and strategies on tracking and managing adolescent mood disorders. Additionally, ongoing medication management and crisis family sessions will be available if required.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

KSADS Mania Rating Scale (KMRS)

Measures symptom severity.

Time frame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)

KSADS Depression Section (KDRS)

Measures symptom severity.

Time frame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)

Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE)

Used to track symptom severity, treatment (both psychosocial and psychotropic), self-injurious/suicidal behavior and psychosocial functioning over time.

Time frame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)

The Family Environment Scale (FES)

Examines each family member's perceptions of the family in three ways-as it is (real), as it would be in a perfect situation (ideal) and as it will probably be in new situations (expected).

Time frame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)

Family Adaptability & Cohesion & Adaptability Scale (FACES)

Evaluate the adaptability and cohesion dimensions in family interactions.

Time frame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)

Conflict Behaviour Questionnaire (CBQ)

Measures conflict and negative communication between parents and adolescents.

Time frame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)

Issues Checklist

Measures potential areas of conflict between parents and adolescents.

Time frame: Change from baseline to endpoint (assessed at 0, 4 and 12 months)

Cortisol

Stress-related biomarker obtained through saliva samples.

Time frame: Change from baseline to endpoint (assessed at 0, 4, and 12 months)

Interleukin 6 (IL-6)

Stress-related biomarker obtained through saliva samples.

Time frame: Change from baseline to endpoint (assessed at weeks 0, 4, and 12 months)

Alpha Amylase

Stress-related biomarker obtained through saliva samples.

Time frame: Change from baseline to endpoint (assessed at 0, 4, and 12 months)

Five Minute Speech Sample

Assesses level of expressed emotion (EE) within the parental household.

Time frame: Change from baseline to endpoint (assessed at 0, 4, and 12 months)

Emotional Response to Conflict Scale (ERCS)

Assesses individuals' emotional responses to a brief, laboratory based, conflict negotiation task.

Time frame: Change from baseline to endpoint (assessed at 0, 4 and 12 months)

Secondary Outcomes

Children Global Assessment Scale

Quantifies overall level of functioning for a child or adolescent during a specified time period.

Time frame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)

Anthromorphic Data

Measures height, weight, body mass index, \& blood pressure.

Time frame: Change from baseline to endpoint (Assessed at weeks 0 and 12 months)

Working Alliance Inventory Short-Revised (WAI-SR)

Measures therapeutic alliance.

Time frame: 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.

General Information Sheet

Demographics

Time frame: Baseline

Family Focused Therapy for Teens at Risk for Bipolar Disorder

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes