Clinical Trials Directory

Trials / Terminated

TerminatedNCT02355366

Family Focused Therapy for Teens at Risk for Bipolar Disorder

Family Focused Therapy (FFT) for Adolescents at Familial Risk for Bipolar

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
2 (actual)
Sponsor
Sunnybrook Health Sciences Centre · Academic / Other
Sex
All
Age
13 Years – 19 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALFamily-Focused TherapyFamily 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).
BEHAVIORALBrief Educational TreatmentBrief 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.

Timeline

Start date
2015-04-01
Primary completion
2018-11-26
Completion
2018-11-26
First posted
2015-02-04
Last updated
2019-01-22

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02355366. Inclusion in this directory is not an endorsement.