Family Focused Therapy for Teens at Risk for Bipolar Disorder

NCT ID: NCT02355366

Last Updated: 2019-01-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2018-11-26

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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Family-Focused Therapy

Intervention Type: BEHAVIORAL

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

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

Group Type: ACTIVE_COMPARATOR

Brief Educational Treatment

Intervention Type: BEHAVIORAL

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

FFT; Family Therapy; Psychosocial Intervention; Psychoeducaton; Psychotherapy; Behaviour Therapy; Psychoeducation; Diagnostic Evaluation; Crisis Management

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Benjamin Goldstein

Associate Professor, University of Toronto

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 23357439 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 22801288 (View on PubMed)

Other Identifiers

404-2014

Identifier Type: -

Identifier Source: org_study_id