Family Focused Therapy for Teens at Risk for Bipolar Disorder

January 18, 2019 updated by: Dr. Benjamin Goldstein, Sunnybrook Health Sciences Centre

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 15 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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).
Behavioral: Family-Focused Therapy
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).
Other Names:
  • Psychosocial Intervention
  • Family Therapy
  • FFT
  • Psychotherapy
  • Psychoeducaton
  • Behaviour Therapy
Active Comparator: 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.
Behavioral: Brief Educational Treatment
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.
Other Names:
  • Psychoeducation
  • Diagnostic Evaluation
  • Crisis Management

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
KSADS Mania Rating Scale (KMRS)
Time Frame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Measures symptom severity.
Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
KSADS Depression Section (KDRS)
Time Frame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Measures symptom severity.
Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE)
Time Frame: 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.
Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
The Family Environment Scale (FES)
Time Frame: 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).
Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Family Adaptability & Cohesion & Adaptability Scale (FACES)
Time Frame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Evaluate the adaptability and cohesion dimensions in family interactions.
Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Conflict Behaviour Questionnaire (CBQ)
Time Frame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Measures conflict and negative communication between parents and adolescents.
Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Issues Checklist
Time Frame: Change from baseline to endpoint (assessed at 0, 4 and 12 months)
Measures potential areas of conflict between parents and adolescents.
Change from baseline to endpoint (assessed at 0, 4 and 12 months)
Cortisol
Time Frame: Change from baseline to endpoint (assessed at 0, 4, and 12 months)
Stress-related biomarker obtained through saliva samples.
Change from baseline to endpoint (assessed at 0, 4, and 12 months)
Interleukin 6 (IL-6)
Time Frame: Change from baseline to endpoint (assessed at weeks 0, 4, and 12 months)
Stress-related biomarker obtained through saliva samples.
Change from baseline to endpoint (assessed at weeks 0, 4, and 12 months)
Alpha Amylase
Time Frame: Change from baseline to endpoint (assessed at 0, 4, and 12 months)
Stress-related biomarker obtained through saliva samples.
Change from baseline to endpoint (assessed at 0, 4, and 12 months)
Five Minute Speech Sample
Time Frame: Change from baseline to endpoint (assessed at 0, 4, and 12 months)
Assesses level of expressed emotion (EE) within the parental household.
Change from baseline to endpoint (assessed at 0, 4, and 12 months)
Emotional Response to Conflict Scale (ERCS)
Time Frame: Change from baseline to endpoint (assessed at 0, 4 and 12 months)
Assesses individuals' emotional responses to a brief, laboratory based, conflict negotiation task.
Change from baseline to endpoint (assessed at 0, 4 and 12 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Children Global Assessment Scale
Time Frame: 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.
Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Anthromorphic Data
Time Frame: Change from baseline to endpoint (Assessed at weeks 0 and 12 months)
Measures height, weight, body mass index, & blood pressure.
Change from baseline to endpoint (Assessed at weeks 0 and 12 months)
Working Alliance Inventory Short-Revised (WAI-SR)
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.
Measures therapeutic alliance.
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
Time Frame: Baseline
Demographics
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 26, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 26, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 404-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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