Family Focused Therapy for Teens at Risk for Bipolar Disorder

Sunnybrook Health Sciences Centre

Status: Terminated

Conditions: Bipolar Disorder

Treatments: Behavioral: Family-Focused Therapy; Behavioral: Brief Educational Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02355366

404-2014

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 13 to 19 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

Family Focused Therapy (FFT)

Experimental group

Description:

Participants will receive Family-Focused Therapy (FFT). It will consist of twelve, 1-hour long sessions, over a period of 4 months. The 12 sessions will include psychoeducation (sessions 1-4), training in communication enhancement (sessions 5-8) and training in relation to problem-solving skills (sessions 9-12).

Treatment:

Behavioral: Family-Focused Therapy

Brief Educational Treatment

Active Comparator group

Description:

Participants will be receive 1-2 educational sessions which will include diagnostic feedback, recommendations for further treatment and crisis intervention if required.

Treatment:

Behavioral: Brief Educational Treatment