An interventional study of Family-Focused Therapy and Brief Educational Treatment in Bipolar Disorder, sponsored by Sunnybrook Health Sciences Centre. Terminated at 1 site in Canada. Open to participants aged 13 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-22.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Prevention
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.
1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.
This study's enrollment of 2 is below the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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All participants will complete rigorous diagnostic interviews to ensure that they meet these requirements.
Exclusion Criteria:
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).
Behavioral: Family-Focused Therapy
Participants will be receive 1-2 educational sessions which will include diagnostic feedback, recommendations for further treatment and crisis intervention if required.
Behavioral: Brief Educational Treatment
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).
Also known as: FFT, Family Therapy, Psychosocial Intervention, Psychoeducaton, Psychotherapy, Behaviour Therapy
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.
Also known as: Psychoeducation, Diagnostic Evaluation, Crisis Management
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)
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
This study is terminated, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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