Family Focused Therapy for Teens at Risk for Bipolar Disorder

Not Applicable

Terminated

• Conditions: Bipolar Disorder
• Interventions: Behavioral: Brief Educational Treatment; Behavioral: Family-Focused Therapy

• Registration Number: NCT02355366
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief 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.

Study Timeline

• Study First Submitted: 2015-01-30
• Study First Submitted QC: 2015-02-03
• Study First Posted: 2015-02-04
• Study Start: 2015-04
• Primary Completion: 2018-11-26
• Study Completion: 2018-11-26
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-18
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief Educational Treatment	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.
Family Focused Therapy (FFT)	Family-Focused Therapy	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).

Primary Outcome Measures

Name	Time	Method
Family Adaptability & Cohesion & Adaptability Scale (FACES)	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)	Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)	Measures conflict and negative communication between parents and adolescents.
Issues Checklist	Change from baseline to endpoint (assessed at 0, 4 and 12 months)	Measures potential areas of conflict between parents and adolescents.
Cortisol	Change from baseline to endpoint (assessed at 0, 4, and 12 months)	Stress-related biomarker obtained through saliva samples.
KSADS Depression Section (KDRS)	Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)	Measures symptom severity.
KSADS Mania Rating Scale (KMRS)	Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)	Measures symptom severity.
Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE)	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)	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)	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	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)	Change from baseline to endpoint (assessed at weeks 0, 4, and 12 months)	Stress-related biomarker obtained through saliva samples.
Alpha Amylase	Change from baseline to endpoint (assessed at 0, 4, and 12 months)	Stress-related biomarker obtained through saliva samples.

Secondary Outcome Measures

Name	Time	Method
General Information Sheet	Baseline	Demographics
Children Global Assessment Scale	Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)	Quantifies overall level of functioning for a child or adolescent during a specified time period.
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.	Measures therapeutic alliance.
Anthromorphic Data	Change from baseline to endpoint (Assessed at weeks 0 and 12 months)	Measures height, weight, body mass index, \& blood pressure.

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada