Family Focused Therapy (FFT) for Adolescents at Familial Risk for Bipolar
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Family Adaptability & Cohesion & Adaptability Scale (FACES)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English-speaking males and females of any race/ethnicity
- •13-19 years of age
- •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)
- •Adolescent is experiencing current, significant mood symptoms indicated by a psychiatric status rating (PSR) score of 3
- •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.
排除标准
- •Unable to provide informed consent (e.g., severe psychosis, developmental delay)
- •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)
- •Are victims of current sexual or physical abuse by parents or live among domestic violence
- •For offspring, already meet criteria for bipolar disorder (BD) type I or II.
研究组 & 干预措施
Family Focused Therapy (FFT)
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).
干预措施: Family-Focused Therapy (Behavioral)
Brief Educational Treatment
Participants will be receive 1-2 educational sessions which will include diagnostic feedback, recommendations for further treatment and crisis intervention if required.
干预措施: Brief Educational Treatment (Behavioral)
结局指标
主要结局
Family Adaptability & Cohesion & Adaptability Scale (FACES)
时间窗: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Evaluate the adaptability and cohesion dimensions in family interactions.
Conflict Behaviour Questionnaire (CBQ)
时间窗: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Measures conflict and negative communication between parents and adolescents.
Issues Checklist
时间窗: Change from baseline to endpoint (assessed at 0, 4 and 12 months)
Measures potential areas of conflict between parents and adolescents.
Cortisol
时间窗: Change from baseline to endpoint (assessed at 0, 4, and 12 months)
Stress-related biomarker obtained through saliva samples.
KSADS Depression Section (KDRS)
时间窗: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Measures symptom severity.
KSADS Mania Rating Scale (KMRS)
时间窗: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Measures symptom severity.
Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE)
时间窗: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Used to track symptom severity, treatment (both psychosocial and psychotropic), self-injurious/suicidal behavior and psychosocial functioning over time.
The Family Environment Scale (FES)
时间窗: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
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).
Emotional Response to Conflict Scale (ERCS)
时间窗: Change from baseline to endpoint (assessed at 0, 4 and 12 months)
Assesses individuals' emotional responses to a brief, laboratory based, conflict negotiation task.
Five Minute Speech Sample
时间窗: Change from baseline to endpoint (assessed at 0, 4, and 12 months)
Assesses level of expressed emotion (EE) within the parental household.
Interleukin 6 (IL-6)
时间窗: Change from baseline to endpoint (assessed at weeks 0, 4, and 12 months)
Stress-related biomarker obtained through saliva samples.
Alpha Amylase
时间窗: Change from baseline to endpoint (assessed at 0, 4, and 12 months)
Stress-related biomarker obtained through saliva samples.
次要结局
- General Information Sheet(Baseline)
- Children Global Assessment Scale(Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months))
- Working Alliance Inventory Short-Revised (WAI-SR)(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.)
- Anthromorphic Data(Change from baseline to endpoint (Assessed at weeks 0 and 12 months))
研究者
Dr. Benjamin Goldstein
Associate Professor, University of Toronto
Sunnybrook Health Sciences Centre