Family Focused Therapy for Teens at Risk for Bipolar Disorder

NCT02355366 | Terminated DMC

• 1 other identifier: 404-2014
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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).

Conditions

Bipolar Disorder

Keywords

Offspring; significant mood symptoms

Outcome Measures

Primary Outcomes (12)

• KSADS Mania Rating Scale (KMRS)

  Measures symptom severity.

  Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)

• KSADS Depression Section (KDRS)

  Measures symptom severity.

  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.

  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).

  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.

  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.

  Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)

• Issues Checklist

  Measures potential areas of conflict between parents and adolescents.

  Change from baseline to endpoint (assessed at 0, 4 and 12 months)

• Cortisol

  Stress-related biomarker obtained through saliva samples.

  Change from baseline to endpoint (assessed at 0, 4, and 12 months)

• Interleukin 6 (IL-6)

  Stress-related biomarker obtained through saliva samples.

  Change from baseline to endpoint (assessed at weeks 0, 4, and 12 months)

• Alpha Amylase

  Stress-related biomarker obtained through saliva samples.

  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.

  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.

  Change from baseline to endpoint (assessed at 0, 4 and 12 months)

Secondary Outcomes (4)

• Children Global Assessment Scale

  Change from baseline to endpoint (assessed at 0, 4, 8 and 12 months)

• Anthromorphic Data

  Change from baseline to endpoint (Assessed at weeks 0 and 12 months)

• Working Alliance Inventory Short-Revised (WAI-SR)

  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

  Baseline

Study Arms (2)

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).

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.

Behavioral: Brief Educational Treatment

Interventions

Family-Focused Therapy 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).

Also known as: FFT, Family Therapy, Psychosocial Intervention, Psychoeducaton, Psychotherapy, Behaviour Therapy

Family Focused Therapy (FFT)

Brief Educational Treatment 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.

Also known as: Psychoeducation, Diagnostic Evaluation, Crisis Management

Brief Educational Treatment

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• English-speaking males and females of any race/ethnicity
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related 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.

  PMID: 23357439 BACKGROUND

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

  PMID: 22801288 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Family Therapy; Psychosocial Intervention; Psychotherapy; Behavior Therapy; Diagnostic Self Evaluation; Crew Resource Management, Healthcare

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy, Group; Socioenvironmental Therapy; Behavioral Disciplines and Activities; Diagnostic Techniques and Procedures; Diagnosis; Patient Care Management; Health Services Administration

Study Officials

• Benjamin Goldstein, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, University of Toronto

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: February 4, 2015
• Study Start: April 1, 2015
• Primary Completion: November 26, 2018
• Study Completion: November 26, 2018
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

CA (1)