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Family Focused Therapy for Teens at Risk for Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Family-Focused Therapy
Brief Educational Treatment
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bipolar Disorder focused on measuring Offspring, significant mood symptoms

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesAccepts 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.

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family Focused Therapy (FFT)

Brief Educational Treatment

Arm 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).

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

Outcomes

Primary Outcome Measures

KSADS Mania Rating Scale (KMRS)
Measures symptom severity.
KSADS Depression Section (KDRS)
Measures symptom severity.
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.
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).
Family Adaptability & Cohesion & Adaptability Scale (FACES)
Evaluate the adaptability and cohesion dimensions in family interactions.
Conflict Behaviour Questionnaire (CBQ)
Measures conflict and negative communication between parents and adolescents.
Issues Checklist
Measures potential areas of conflict between parents and adolescents.
Cortisol
Stress-related biomarker obtained through saliva samples.
Interleukin 6 (IL-6)
Stress-related biomarker obtained through saliva samples.
Alpha Amylase
Stress-related biomarker obtained through saliva samples.
Five Minute Speech Sample
Assesses level of expressed emotion (EE) within the parental household.
Emotional Response to Conflict Scale (ERCS)
Assesses individuals' emotional responses to a brief, laboratory based, conflict negotiation task.

Secondary Outcome Measures

Children Global Assessment Scale
Quantifies overall level of functioning for a child or adolescent during a specified time period.
Anthromorphic Data
Measures height, weight, body mass index, & blood pressure.
Working Alliance Inventory Short-Revised (WAI-SR)
Measures therapeutic alliance.
General Information Sheet
Demographics

Full Information

First Posted
January 30, 2015
Last Updated
January 18, 2019
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02355366
Brief Title
Family Focused Therapy for Teens at Risk for Bipolar Disorder
Official Title
Family Focused Therapy (FFT) for Adolescents at Familial Risk for Bipolar
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Study Start Date
April 2015 (undefined)
Primary Completion Date
November 26, 2018 (Actual)
Study Completion Date
November 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Offspring, significant mood symptoms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Focused Therapy (FFT)
Arm Type
Experimental
Arm 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).
Arm Title
Brief Educational Treatment
Arm Type
Active Comparator
Arm Description
Participants will be receive 1-2 educational sessions which will include diagnostic feedback, recommendations for further treatment and crisis intervention if required.
Intervention Type
Behavioral
Intervention Name(s)
Family-Focused Therapy
Other Intervention Name(s)
FFT, Family Therapy, Psychosocial Intervention, Psychoeducaton, Psychotherapy, Behaviour Therapy
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Brief Educational Treatment
Other Intervention Name(s)
Psychoeducation, Diagnostic Evaluation, Crisis Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
KSADS Mania Rating Scale (KMRS)
Description
Measures symptom severity.
Time Frame
Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Title
KSADS Depression Section (KDRS)
Description
Measures symptom severity.
Time Frame
Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Title
Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE)
Description
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)
Title
The Family Environment Scale (FES)
Description
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)
Title
Family Adaptability & Cohesion & Adaptability Scale (FACES)
Description
Evaluate the adaptability and cohesion dimensions in family interactions.
Time Frame
Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Title
Conflict Behaviour Questionnaire (CBQ)
Description
Measures conflict and negative communication between parents and adolescents.
Time Frame
Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Title
Issues Checklist
Description
Measures potential areas of conflict between parents and adolescents.
Time Frame
Change from baseline to endpoint (assessed at 0, 4 and 12 months)
Title
Cortisol
Description
Stress-related biomarker obtained through saliva samples.
Time Frame
Change from baseline to endpoint (assessed at 0, 4, and 12 months)
Title
Interleukin 6 (IL-6)
Description
Stress-related biomarker obtained through saliva samples.
Time Frame
Change from baseline to endpoint (assessed at weeks 0, 4, and 12 months)
Title
Alpha Amylase
Description
Stress-related biomarker obtained through saliva samples.
Time Frame
Change from baseline to endpoint (assessed at 0, 4, and 12 months)
Title
Five Minute Speech Sample
Description
Assesses level of expressed emotion (EE) within the parental household.
Time Frame
Change from baseline to endpoint (assessed at 0, 4, and 12 months)
Title
Emotional Response to Conflict Scale (ERCS)
Description
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)
Secondary Outcome Measure Information:
Title
Children Global Assessment Scale
Description
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)
Title
Anthromorphic Data
Description
Measures height, weight, body mass index, & blood pressure.
Time Frame
Change from baseline to endpoint (Assessed at weeks 0 and 12 months)
Title
Working Alliance Inventory Short-Revised (WAI-SR)
Description
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.
Title
General Information Sheet
Description
Demographics
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Goldstein, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23357439
Citation
Miklowitz DJ, Schneck CD, Singh MK, Taylor DO, George EL, Cosgrove VE, Howe ME, Dickinson LM, Garber J, Chang KD. Early intervention for symptomatic youth at risk for bipolar disorder: a randomized trial of family-focused therapy. J Am Acad Child Adolesc Psychiatry. 2013 Feb;52(2):121-31. doi: 10.1016/j.jaac.2012.10.007. Epub 2013 Jan 2.
Results Reference
background
PubMed Identifier
22801288
Citation
Miklowitz DJ. Family-focused treatment for children and adolescents with bipolar disorder. Isr J Psychiatry Relat Sci. 2012;49(2):95-101.
Results Reference
background

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Family Focused Therapy for Teens at Risk for Bipolar Disorder

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