Family Focused Therapy for Teens at Risk for Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02355366
• Other study ID #: 404-2014
• Status: Terminated
• Phase: N/A
• Start date: April 2015
• Est. completion date: November 26, 2018

Study information

• Verified date: January 2019
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 26, 2018
• Est. primary completion date: November 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

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).
• 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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

Miklowitz DJ. Family-focused treatment for children and adolescents with bipolar disorder. Isr J Psychiatry Relat Sci. 2012;49(2):95-101. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KSADS Mania Rating Scale (KMRS)	Measures symptom severity.	Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Primary	KSADS Depression Section (KDRS)	Measures symptom severity.	Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Primary	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.	Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Primary	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).	Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Primary	Family Adaptability & Cohesion & Adaptability Scale (FACES)	Evaluate the adaptability and cohesion dimensions in family interactions.	Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Primary	Conflict Behaviour Questionnaire (CBQ)	Measures conflict and negative communication between parents and adolescents.	Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)
Primary	Issues Checklist	Measures potential areas of conflict between parents and adolescents.	Change from baseline to endpoint (assessed at 0, 4 and 12 months)
Primary	Cortisol	Stress-related biomarker obtained through saliva samples.	Change from baseline to endpoint (assessed at 0, 4, and 12 months)
Primary	Interleukin 6 (IL-6)	Stress-related biomarker obtained through saliva samples.	Change from baseline to endpoint (assessed at weeks 0, 4, and 12 months)
Primary	Alpha Amylase	Stress-related biomarker obtained through saliva samples.	Change from baseline to endpoint (assessed at 0, 4, and 12 months)
Primary	Five Minute Speech Sample	Assesses level of expressed emotion (EE) within the parental household.	Change from baseline to endpoint (assessed at 0, 4, and 12 months)
Primary	Emotional Response to Conflict Scale (ERCS)	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	Children Global Assessment Scale	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)
Secondary	Anthromorphic Data	Measures height, weight, body mass index, & blood pressure.	Change from baseline to endpoint (Assessed at weeks 0 and 12 months)
Secondary	Working Alliance Inventory Short-Revised (WAI-SR)	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.
Secondary	General Information Sheet	Demographics	Baseline