Bipolar DisorderNCT02355366
Family Focused Therapy for Teens at Risk for Bipolar Disorder
A study testing Family-Focused Therapy and Brief Educational Treatment in people with Bipolar Disorder, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Family-Focused Therapy and Brief Educational Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to 26 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- Family-Focused Therapy, Brief Educational Treatment
- Keywords
- Offspring, significant mood symptoms
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-Focused TherapyBehavioural
Also called FFT, Family Therapy, Psychosocial Intervention, Psychoeducaton
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).
Brief Educational TreatmentBehavioural
Also called Psychoeducation, Diagnostic Evaluation, Crisis Management
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.
| Study group | Role | What they receive |
|---|---|---|
| Family Focused Therapy (FFT) | Experimental | 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). Receives: Behavioral: Family-Focused Therapy |
| Brief Educational Treatment | Active comparator | Participants will be receive 1-2 educational sessions which will include diagnostic feedback, recommendations for further treatment and crisis intervention if required. Receives: Behavioral: Brief Educational Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
KSADS Mania Rating Scale (KMRS)
Measures symptom severity.
Measured: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
KSADS Depression Section (KDRS)
Measures symptom severity.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Issues Checklist
Measures potential areas of conflict between parents and adolescents.
Measured: Change from baseline to endpoint (assessed at 0, 4 and 12 months)
Cortisol
Stress-related biomarker obtained through saliva samples.
Measured: Change from baseline to endpoint (assessed at 0, 4, and 12 months)
Interleukin 6 (IL-6)
Stress-related biomarker obtained through saliva samples.
Measured: Change from baseline to endpoint (assessed at weeks 0, 4, and 12 months)
Alpha Amylase
Stress-related biomarker obtained through saliva samples.
Measured: 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.
Measured: 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.
Measured: Change from baseline to endpoint (assessed at 0, 4 and 12 months)
Secondary outcomes (4)
Children Global Assessment Scale
Quantifies overall level of functioning for a child or adolescent during a specified time period.
Measured: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Anthromorphic Data
Measures height, weight, body mass index, \& blood pressure.
Measured: Change from baseline to endpoint (Assessed at weeks 0 and 12 months)
Working Alliance Inventory Short-Revised (WAI-SR)
Measures therapeutic alliance.
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startApr 2015
- Primary completion26 Nov 2018
- Study completion26 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Benjamin Goldstein, Sunnybrook Health Sciences Centre
- Investigators
- Benjamin Goldstein, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355366
- Sponsor's protocol ID
- 404-2014
- Status last verified
- Jan 2019
- First submitted
- 30 Jan 2015
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23357439Miklowitz DJ. Family-focused treatment for children and adolescents with bipolar disorder. Isr J Psychiatry Relat Sci. 2012;49(2):95-101.
PubMed 22801288
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Focused Therapy (FFT) for Adolescents at Familial Risk for Bipolar
- ClinicalTrials.gov ID
- NCT02355366
- Acronym / sponsor ID
- 404-2014
- Conditions
- Bipolar Disorder
- Keywords
- Offspring, significant mood symptoms
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 26 Nov 2018 (actual)
- Study completion
- 26 Nov 2018 (actual)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Focused Therapy (FFT) | Experimental | Behavioral: Family-Focused TherapyParticipants 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). |
| Brief Educational Treatment | Active comparator | Behavioral: Brief Educational TreatmentParticipants will be receive 1-2 educational sessions which will include diagnostic feedback, recommendations for further treatment and crisis intervention if required. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-Focused TherapyAlso: FFT, Family Therapy, Psychosocial Intervention, PsychoeducatonFamily 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). | Behavioural | Family Focused Therapy (FFT) |
| Brief Educational TreatmentAlso: Psychoeducation, Diagnostic Evaluation, Crisis ManagementBrief 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. | Behavioural | Brief Educational Treatment |
Primary outcome
KSADS Mania Rating Scale (KMRS)
Time frame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Measures symptom severity.
KSADS Depression Section (KDRS)
Time frame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Measures symptom severity.
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.
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).
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.
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.
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.
Cortisol
Time frame: Change from baseline to endpoint (assessed at 0, 4, and 12 months)
Stress-related biomarker obtained through saliva samples.
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.
Alpha Amylase
Time frame: Change from baseline to endpoint (assessed at 0, 4, and 12 months)
Stress-related biomarker obtained through saliva samples.
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.
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.
4 secondary outcomes
Children Global Assessment Scale
Time frame: 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)
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.
General Information Sheet
Time frame: Baseline
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Background: PubMed 23357439Miklowitz 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.
- Background: PubMed 22801288Miklowitz DJ. Family-focused treatment for children and adolescents with bipolar disorder. Isr J Psychiatry Relat Sci. 2012;49(2):95-101.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Goldstein, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-Focused Therapy and Brief Educational Treatment in people with Bipolar Disorder, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KSADS Mania Rating Scale (KMRS) (time frame: Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02355366, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.