search
Back to results

Dialectical Behavior Therapy for Youth With and/or at Familial Risk for Bipolar Disorder (DB1)

Primary Purpose

Bipolar Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dialectical behavioral therapy
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Youth, Dialectical Behavior Therapy (DBT)

Eligibility Criteria

13 Years - 23 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • English-speaking
  • Age 13 years, 0 months to 23 years, 11 months
  • Meet diagnostic criteria for BD by KSADS-PL
  • If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium)
  • Followed by a CAMH psychiatrist who provides ongoing care
  • At least 1 lifetime suicide attempt (actual, interrupted, and/or aborted as measured by the C-SSRS) -OR- ≥ 3 lifetime non-suicidal self-injurious (NSSI) behaviors, with one behavior occurring in the past 3 months (as measured by the C-SSRS and ALIFE) -OR- a score of ≥ 24 on the SIQ -OR- 6b) Severe emotion dysregulation (score of ≥ 105 on DERS or score of ≥ 20 on the CALS (youth report) -OR- Meet youth threshold for at least 2 impulsive behavior categories on question #4 from the SIDP-IV or 1 category is identified as severe (through case discussion that will focus on level of risk, persistence, and impairment)
  • Able and willing to give informed consent/assent to participate

Exclusion Criteria:

  • Evidence of mental retardation, moderate to severe pervasive developmental disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records
  • A life-threatening medical condition requiring immediate treatment
  • Current victim of sexual or physical abuse
  • Current substance use disorder other than mild cannabis or alcohol use disorder

Sites / Locations

  • Centre for Addiction and Mental HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Youth with and/or at familial risk for bipolar disorder

Arm Description

60 youth aged 13 to 23 with and/or at familial risk for bipolar disorder will be enrolled in the dialectical behavioral therapy intervention.

Outcomes

Primary Outcome Measures

Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
Borderline and antisocial personality symptoms will be assessed using the Structured Interview for DSM-IV Personality. The SID-P uses a semi structured interview format to assess for symptoms of personality disorders. Scores one each item range from 0 to 3 and high scores indicate symptoms of borderline personality disorder and levels of impairment.
Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
Borderline and antisocial personality symptoms will be assessed using the Structured Interview for DSM-IV Personality. The SID-P uses a semi structured interview format to assess for symptoms of personality disorders. Scores one each item range from 0 to 3 and high scores indicate symptoms of borderline personality disorder and levels of impairment.
Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
Self-reported and parent reported depressive and manic symptoms will be measured via the Mood and Feelings Questionnaire (MFQ). Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").
Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
Self-reported and parent reported depressive and manic symptoms will be measured via the Mood and Feelings Questionnaire (MFQ). Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").
Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
Self-reported and parent reported depressive and manic symptoms will be measured via the Mood and Feelings Questionnaire (MFQ). Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").
Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
Self-reported and parent reported depressive and manic symptoms will be measured via the Mood and Feelings Questionnaire (MFQ). Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
Youth participants will complete the self-report Suicidal Ideation (SIQ), which is intended to identify participants whose level of suicidal ideation is severe enough to warrant further intervention. Each item is rated on a 7-point Likert-type scale (0= "I never had this thought" to 6="almost every day") and is used to indicate the frequency with which the participant experiences each thought.
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
Youth participants will complete the self-report Suicidal Ideation (SIQ), which is intended to identify participants whose level of suicidal ideation is severe enough to warrant further intervention. Each item is rated on a 7-point Likert-type scale (0= "I never had this thought" to 6="almost every day") and is used to indicate the frequency with which the participant experiences each thought.
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
Youth participants will complete the self-report Suicidal Ideation (SIQ), which is intended to identify participants whose level of suicidal ideation is severe enough to warrant further intervention. Each item is rated on a 7-point Likert-type scale (0= "I never had this thought" to 6="almost every day") and is used to indicate the frequency with which the participant experiences each thought.
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
Youth participants will complete the self-report Suicidal Ideation (SIQ), which is intended to identify participants whose level of suicidal ideation is severe enough to warrant further intervention. Each item is rated on a 7-point Likert-type scale (0= "I never had this thought" to 6="almost every day") and is used to indicate the frequency with which the participant experiences each thought.
Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
The Longitudinal Interval Follow-up Evaluation (LIFE) will provide a comprehensive cross-sectional and longitudinal picture of the symptomatic and psychosocial course and outcome of all participants in this study. Scores range from 0-3 on certain disorders and 0-6 for other disorders. High scores indicate high level of symptom impairment.
Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
The Longitudinal Interval Follow-up Evaluation (LIFE) will provide a comprehensive cross-sectional and longitudinal picture of the symptomatic and psychosocial course and outcome of all participants in this study. Scores range from 0-3 on certain disorders and 0-6 for other disorders. High scores indicate high level of symptom impairment.
Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal events (past and over follow-up) will be assessed with the Pediatric Version of the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS has sound psychometric properties, yields ratings of widely accepted definitions of youth suicidal events, and was used in other pediatric treatment trials yielding standardized outcomes to compare across studies. This is a semi-structured interview that includes yes/no questions as well as narrative. It captures number of suicidal events as well as type and severity.
Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal events (past and over follow-up) will be assessed with the Pediatric Version of the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS has sound psychometric properties, yields ratings of widely accepted definitions of youth suicidal events, and was used in other pediatric treatment trials yielding standardized outcomes to compare across studies. This is a semi-structured interview that includes yes/no questions as well as narrative. It captures number of suicidal events as well as type and severity.
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Youth participants will complete the Difficulties in Emotion Regulation (DERS), a 36-item questionnaire assessing emotional dysregulation. Participants indicate how often each item applies to them on a scale from 1="almost never; 0-10 percent" to 5= "almost always; 91-100 percent".
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Youth participants will complete the Difficulties in Emotion Regulation (DERS), a 36-item questionnaire assessing emotional dysregulation. Participants indicate how often each item applies to them on a scale from 1="almost never; 0-10 percent" to 5= "almost always; 91-100 percent".
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Youth participants will complete the Difficulties in Emotion Regulation (DERS), a 36-item questionnaire assessing emotional dysregulation. Participants indicate how often each item applies to them on a scale from 1="almost never; 0-10 percent" to 5= "almost always; 91-100 percent".
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Youth participants will complete the Difficulties in Emotion Regulation (DERS), a 36-item questionnaire assessing emotional dysregulation. Participants indicate how often each item applies to them on a scale from 1="almost never; 0-10 percent" to 5= "almost always; 91-100 percent".
Treatment Satisfaction Questionnaire (18-item)
During follow-up visits, participants, parents, and/or siblings who are participating in therapy sessions will complete an 18-item Treatment Satisfaction Questionnaire. This assesses clients' satisfaction of the service (responses range from quite dissatisfied to very satisfied) as well as whether or not the service addressed the clients' needs.
Treatment Satisfaction Questionnaire (18-item)
During follow-up visits, participants, parents, and/or siblings who are participating in therapy sessions will complete an 18-item Treatment Satisfaction Questionnaire. This assesses clients' satisfaction of the service (responses range from quite dissatisfied to very satisfied) as well as whether or not the service addressed the clients' needs.
Treatment Satisfaction Questionnaire (18-item)
During follow-up visits, participants, parents, and/or siblings who are participating in therapy sessions will complete an 18-item Treatment Satisfaction Questionnaire. This assesses clients' satisfaction of the service (responses range from quite dissatisfied to very satisfied) as well as whether or not the service addressed the clients' needs.
Treatment Satisfaction Questionnaire (18-item)
During follow-up visits, participants, parents, and/or siblings who are participating in therapy sessions will complete an 18-item Treatment Satisfaction Questionnaire. This assesses clients' satisfaction of the service (responses range from quite dissatisfied to very satisfied) as well as whether or not the service addressed the clients' needs.
Change in affective lability using the Children's Affective Lability Scale (CALS)
The Children's Affective Lability Scale (CALS) is a reliable 20-item adolescent- and parent-reported measure of mood lability, derived from the adult Affective Lability Scale that was specifically designed for adults with BD. It yields a total score as well as an angry/depressed factor and a disinhibited/impersistent factor. Total scores can vary from 0 to 80, with lower scores indicating a lesser degree of affective lability.
Change in affective lability using the Children's Affective Lability Scale (CALS)
The Children's Affective Lability Scale (CALS) is a reliable 20-item adolescent- and parent-reported measure of mood lability, derived from the adult Affective Lability Scale that was specifically designed for adults with BD. It yields a total score as well as an angry/depressed factor and a disinhibited/impersistent factor. Total scores can vary from 0 to 80, with lower scores indicating a lesser degree of affective lability.
Change in affective lability using the Children's Affective Lability Scale (CALS)
The Children's Affective Lability Scale (CALS) is a reliable 20-item adolescent- and parent-reported measure of mood lability, derived from the adult Affective Lability Scale that was specifically designed for adults with BD. It yields a total score as well as an angry/depressed factor and a disinhibited/impersistent factor. Total scores can vary from 0 to 80, with lower scores indicating a lesser degree of affective lability.
Change in affective lability using the Children's Affective Lability Scale (CALS)
The Children's Affective Lability Scale (CALS) is a reliable 20-item adolescent- and parent-reported measure of mood lability, derived from the adult Affective Lability Scale that was specifically designed for adults with BD. It yields a total score as well as an angry/depressed factor and a disinhibited/impersistent factor. Total scores can vary from 0 to 80, with lower scores indicating a lesser degree of affective lability.
Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
Youth participants will complete the DBT-WCCL, a 59-item questionnaire assessing the use of DBT skills and coping strategies. Participants indicate how often they engaged in the thought/behavior from 0= "never used" to 3= "regularly used".
Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
Youth participants will complete the DBT-WCCL, a 59-item questionnaire assessing the use of DBT skills and coping strategies. Participants indicate how often they engaged in the thought/behavior from 0= "never used" to 3= "regularly used".
Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
Youth participants will complete the DBT-WCCL, a 59-item questionnaire assessing the use of DBT skills and coping strategies. Participants indicate how often they engaged in the thought/behavior from 0= "never used" to 3= "regularly used".
Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
Youth participants will complete the DBT-WCCL, a 59-item questionnaire assessing the use of DBT skills and coping strategies. Participants indicate how often they engaged in the thought/behavior from 0= "never used" to 3= "regularly used".
Change in functioning using the Children's Global Assessment Scale (C-GAS)
The Children's Global Assessment Scale (C-GAS) is an adaptation of the Global Assessment of Functioning Scale (GAF) developed to reflect the lowest level of functioning for a child or adolescent during a specified time period. Scores can range from 1-100, with scores above 70 designated as indicating normal functioning. This scale was found to be reliable between interviewers across time. Also, it has demonstrated both discriminant and concurrent validity.
Change in functioning using the Children's Global Assessment Scale (C-GAS)
The Children's Global Assessment Scale (C-GAS) is an adaptation of the Global Assessment of Functioning Scale (GAF) developed to reflect the lowest level of functioning for a child or adolescent during a specified time period. Scores can range from 1-100, with scores above 70 designated as indicating normal functioning. This scale was found to be reliable between interviewers across time. Also, it has demonstrated both discriminant and concurrent validity.
Change in temperament using the Conflict Behavior Questionnaire (CBQ)
The Conflict Behavior Questionnaire (CBQ) is a youth and parent 20-item self-report instrument that taps into conflict and negative communication between parents and their children. Items are rated as "true" or "false". Higher scores indicate greater levels of conflict and negative communication.
Change in temperament using the Conflict Behavior Questionnaire (CBQ)
The Conflict Behavior Questionnaire (CBQ) is a youth and parent 20-item self-report instrument that taps into conflict and negative communication between parents and their children. Items are rated as "true" or "false". Higher scores indicate greater levels of conflict and negative communication.
Change in temperament using the Conflict Behavior Questionnaire (CBQ)
The Conflict Behavior Questionnaire (CBQ) is a youth and parent 20-item self-report instrument that taps into conflict and negative communication between parents and their children. Items are rated as "true" or "false". Higher scores indicate greater levels of conflict and negative communication.
Change in temperament using the Conflict Behavior Questionnaire (CBQ)
The Conflict Behavior Questionnaire (CBQ) is a youth and parent 20-item self-report instrument that taps into conflict and negative communication between parents and their children. Items are rated as "true" or "false". Higher scores indicate greater levels of conflict and negative communication.
Change in family functioning using the Family Adaptability and Cohesion Evaluation Scale, IV (FACES-IV)
The Family Adaptability and Cohesion Evaluation Scale (FACES-IV) was developed to evaluate the adaptability and cohesion dimensions in family interactions. Youth and parents will complete this self-report questionnaire. Six scales were developed, with two balanced scales and four unbalanced scales designed to tap low and high cohesion (disengaged and enmeshed) and flexibility (rigid and chaotic). Ratio scores above 1 indicate healthier families whereas ratio scores below 1 indicate more problematic families. The six scales in FACES-IV were found to be reliable and valid. Additionally, high levels of concurrent, construct, and discriminant validity were found.
Change in family functioning using the Family Adaptability and Cohesion Evaluation Scale, IV (FACES-IV)
The Family Adaptability and Cohesion Evaluation Scale (FACES-IV) was developed to evaluate the adaptability and cohesion dimensions in family interactions. Youth and parents will complete this self-report questionnaire. Six scales were developed, with two balanced scales and four unbalanced scales designed to tap low and high cohesion (disengaged and enmeshed) and flexibility (rigid and chaotic). Ratio scores above 1 indicate healthier families whereas ratio scores below 1 indicate more problematic families. The six scales in FACES-IV were found to be reliable and valid. Additionally, high levels of concurrent, construct, and discriminant validity were found.
Change in family functioning using the Family Adaptability and Cohesion Evaluation Scale, IV (FACES-IV)
The Family Adaptability and Cohesion Evaluation Scale (FACES-IV) was developed to evaluate the adaptability and cohesion dimensions in family interactions. Youth and parents will complete this self-report questionnaire. Six scales were developed, with two balanced scales and four unbalanced scales designed to tap low and high cohesion (disengaged and enmeshed) and flexibility (rigid and chaotic). Ratio scores above 1 indicate healthier families whereas ratio scores below 1 indicate more problematic families. The six scales in FACES-IV were found to be reliable and valid. Additionally, high levels of concurrent, construct, and discriminant validity were found.
Change in family functioning using the Family Adaptability and Cohesion Evaluation Scale, IV (FACES-IV)
The Family Adaptability and Cohesion Evaluation Scale (FACES-IV) was developed to evaluate the adaptability and cohesion dimensions in family interactions. Youth and parents will complete this self-report questionnaire. Six scales were developed, with two balanced scales and four unbalanced scales designed to tap low and high cohesion (disengaged and enmeshed) and flexibility (rigid and chaotic). Ratio scores above 1 indicate healthier families whereas ratio scores below 1 indicate more problematic families. The six scales in FACES-IV were found to be reliable and valid. Additionally, high levels of concurrent, construct, and discriminant validity were found.
Number, frequency, and type of therapy sessions
The Therapy Tracking Form will be used to document the date of the therapy session, type of session, session duration, content, and scheduled date for next therapy visit. This form will be completed by the study therapist after each therapy session.

Secondary Outcome Measures

Childhood Trust Events Survey (CTES)
Youth will complete the Childhood Trust Events Survey (CTES) long-form, adolescent version, a 30-item self-report screening survey that assesses exposure to adversity across a breadth of domains including physical, emotional, and sexual abuse; alcohol/drug users in home; family members in prison; caregiver with mental illness; domestic violence; loss/separation from caregiver; and other traumatic events. In addition, the CTES queries the age and perceived intensity of each type of adversity. Parents will complete the caregiver version of the CTES, a 26-item survey that asks if their child has been exposed to the same domains of adversity as queried in the adolescent version.
Change in parental psychological distress using the Symptom Checklist-90 (SCL-90)
The Symptom Checklist-90 (SCL-90) is 90-item parent-reported measure used to assess symptoms and complaints that parents may have. It assesses the following dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and other.
Change in parental psychological distress using the Symptom Checklist-90 (SCL-90)
The Symptom Checklist-90 (SCL-90) is 90-item parent-reported measure used to assess symptoms and complaints that parents may have. It assesses the following dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and other.
Change in parental psychological distress using the Symptom Checklist-90 (SCL-90)
The Symptom Checklist-90 (SCL-90) is 90-item parent-reported measure used to assess symptoms and complaints that parents may have. It assesses the following dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and other.
Change in parental psychological distress using the Symptom Checklist-90 (SCL-90)
The Symptom Checklist-90 (SCL-90) is 90-item parent-reported measure used to assess symptoms and complaints that parents may have. It assesses the following dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and other.

Full Information

First Posted
November 5, 2021
Last Updated
April 5, 2023
Sponsor
Centre for Addiction and Mental Health
search

1. Study Identification

Unique Protocol Identification Number
NCT05153382
Brief Title
Dialectical Behavior Therapy for Youth With and/or at Familial Risk for Bipolar Disorder
Acronym
DB1
Official Title
Dialectical Behavior Therapy for Youth With and/or at Familial Risk for Bipolar Disorder: Focus on Predictors and Mediators of Treatment Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
November 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Dialectical behavior therapy (DBT) will be conducted over 1 year in youth with and/or at familial risk for bipolar disorder (BD). DBT will be divided into two modalities: 1) DBT skills training; and 2) DBT individual therapy sessions. Skills training sessions will incorporate the 5 standard adolescent DBT modules: mindfulness skills, emotion regulation skills, distress tolerance skills, interpersonal skills, and walking the middle path skills and an additional module on psychoeducation about DBT and BD. This study seeks to build upon the knowledge base in this area by offering DBT to youth with and/or at familial risk for BD with an emphasis on predictors and mediators of treatment outcomes.
Detailed Description
In recent years, studies led by investigators at the University of Pittsburgh have emerged that demonstrate the promise of adapting dialectical behavior therapy (DBT) to align with the unique needs of youth with bipolar disorder (BD). Our group has conducted a dissemination and implementation DBT study at Sunnybrook Health Sciences Centre focused specifically on youth with BD. Preliminary data from that study demonstrate that the study therapists, now at CAMH, have achieved fidelity and competence in delivering the intervention, as evidenced by adherence coding scores and participant outcomes. The DBT intervention is based on Miller et al.'s DBT for suicidal adolescents, with modifications for youth with BD. A co-investigator on this study, Dr. T. Goldstein, developed and refined the manualized treatment during her National Institute of Mental Health K23 award in consultation with Dr. Miller. In keeping with the protocol implemented in prior studies, DBT in the present study will be conducted over 1 year, and divided into two modalities: 1) DBT skills training (approximately 60 minute biweekly meetings); and 2) DBT individual therapy sessions (approximately 60 minute biweekly sessions) alternating with skills training. Family involvement in skills training will be strongly encouraged, but not mandatory. Master's level therapists with clinical experience in youth with BD and their families will conduct DBT. This study includes 1 year of assessments (intake, 3, 6, 9, and 12 months) while the intervention is being delivered. The target sample size will be 60 youth with and/or at familial risk for BD ranging from 13 to 23 years of age. The current study endeavors to build upon the knowledge base in this area by offering DBT to youth with and/or at familial risk for BD at CAMH with an emphasis on predictors and mediators of treatment outcomes, with the eventual goal of personalizing treatment selection and delivery. While DBT bodes favorably as a treatment for youth with BD, the literature in this area remains sparse. Moreover, the investigators do not yet understand what clinical characteristics and pre-treatment variables predict and mediate treatment outcomes. There is substantial between-person and within-person variability among youth with and/or at familial risk for BD in terms of risk indicators, type and severity of symptoms, associated distress, and compounding functional impairment. The current study proposes to move beyond questions of efficacy toward identifying individual characteristics that are differentially associated with response to DBT. Identification of baseline demographic and clinical characteristics that are associated with response to DBT (i.e., predictors), as well as time-varying characteristics during the course of treatment (i.e., mediators), could guide iterative optimization of DBT through individualized modifications. Patient engagement will be sought through consultation forums after they have completed the study. Overall, this research endeavors to begin to examine the patient factors that predict and mediate an individual's response to DBT, with important questions to consider, such as: For which youth with and/or at familial risk for BD does this intervention have the greatest effect? Does the intervention have similar effects across sub-groups of youth with BD? The investigators anticipate that the identification of predictor and mediating variables has the potential to inform the iterative personalization of DBT for youth with and/or at familial risk for BD in the future, including content, timing, and relative emphasis on various aspects of DBT (e.g., psychoeducation, skills, individual sessions, family involvement, phone coaching).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Youth, Dialectical Behavior Therapy (DBT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Youth with and/or at familial risk for bipolar disorder
Arm Type
Experimental
Arm Description
60 youth aged 13 to 23 with and/or at familial risk for bipolar disorder will be enrolled in the dialectical behavioral therapy intervention.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical behavioral therapy
Other Intervention Name(s)
DBT
Intervention Description
DBT will be conducted over 1 year, and divided into two modalities: skills training, conducted in 60 minute biweekly meetings and individual therapy conducted in 60 minute biweekly sessions. Family participation in skills training is highly encouraged. Skills training proceeds as follows: psychoeducation, mindfulness skills, emotion regulation skills, distress tolerance skills, interpersonal skills, and walking the middle path skills. Individual therapy sessions aim to aid the youth in applying skills in their daily lives. We adopt the standard DBT hierarchy of treatment targets, whereby the individual therapist selects behaviors to focus on based on the following priorities: 1) decreasing life-threatening behaviors, 2) decreasing therapy-interfering behaviors, 3) decreasing quality-of-life interfering behaviors, and 4) increasing behavioral skills. Therapists will be available to participants by cell phone for in-vivo skills coaching between sessions.
Primary Outcome Measure Information:
Title
Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
Description
Borderline and antisocial personality symptoms will be assessed using the Structured Interview for DSM-IV Personality. The SID-P uses a semi structured interview format to assess for symptoms of personality disorders. Scores one each item range from 0 to 3 and high scores indicate symptoms of borderline personality disorder and levels of impairment.
Time Frame
Baseline to 6 months
Title
Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
Description
Borderline and antisocial personality symptoms will be assessed using the Structured Interview for DSM-IV Personality. The SID-P uses a semi structured interview format to assess for symptoms of personality disorders. Scores one each item range from 0 to 3 and high scores indicate symptoms of borderline personality disorder and levels of impairment.
Time Frame
6 months to 12 months
Title
Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
Description
Self-reported and parent reported depressive and manic symptoms will be measured via the Mood and Feelings Questionnaire (MFQ). Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").
Time Frame
Baseline to 3 months
Title
Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
Description
Self-reported and parent reported depressive and manic symptoms will be measured via the Mood and Feelings Questionnaire (MFQ). Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").
Time Frame
3 months to 6 months
Title
Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
Description
Self-reported and parent reported depressive and manic symptoms will be measured via the Mood and Feelings Questionnaire (MFQ). Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").
Time Frame
6 months to 9 months
Title
Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
Description
Self-reported and parent reported depressive and manic symptoms will be measured via the Mood and Feelings Questionnaire (MFQ). Responses are made on a 3-point scale ("0=not true", "1=sometimes true" and "2=true").
Time Frame
9 months to 12 months
Title
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
Description
Youth participants will complete the self-report Suicidal Ideation (SIQ), which is intended to identify participants whose level of suicidal ideation is severe enough to warrant further intervention. Each item is rated on a 7-point Likert-type scale (0= "I never had this thought" to 6="almost every day") and is used to indicate the frequency with which the participant experiences each thought.
Time Frame
Baseline to 3 months
Title
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
Description
Youth participants will complete the self-report Suicidal Ideation (SIQ), which is intended to identify participants whose level of suicidal ideation is severe enough to warrant further intervention. Each item is rated on a 7-point Likert-type scale (0= "I never had this thought" to 6="almost every day") and is used to indicate the frequency with which the participant experiences each thought.
Time Frame
3 months to 6 months
Title
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
Description
Youth participants will complete the self-report Suicidal Ideation (SIQ), which is intended to identify participants whose level of suicidal ideation is severe enough to warrant further intervention. Each item is rated on a 7-point Likert-type scale (0= "I never had this thought" to 6="almost every day") and is used to indicate the frequency with which the participant experiences each thought.
Time Frame
6 months to 9 months
Title
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
Description
Youth participants will complete the self-report Suicidal Ideation (SIQ), which is intended to identify participants whose level of suicidal ideation is severe enough to warrant further intervention. Each item is rated on a 7-point Likert-type scale (0= "I never had this thought" to 6="almost every day") and is used to indicate the frequency with which the participant experiences each thought.
Time Frame
9 months to 12 months
Title
Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
Description
The Longitudinal Interval Follow-up Evaluation (LIFE) will provide a comprehensive cross-sectional and longitudinal picture of the symptomatic and psychosocial course and outcome of all participants in this study. Scores range from 0-3 on certain disorders and 0-6 for other disorders. High scores indicate high level of symptom impairment.
Time Frame
Baseline to 6 months
Title
Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
Description
The Longitudinal Interval Follow-up Evaluation (LIFE) will provide a comprehensive cross-sectional and longitudinal picture of the symptomatic and psychosocial course and outcome of all participants in this study. Scores range from 0-3 on certain disorders and 0-6 for other disorders. High scores indicate high level of symptom impairment.
Time Frame
6 months to 12 months
Title
Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
Suicidal events (past and over follow-up) will be assessed with the Pediatric Version of the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS has sound psychometric properties, yields ratings of widely accepted definitions of youth suicidal events, and was used in other pediatric treatment trials yielding standardized outcomes to compare across studies. This is a semi-structured interview that includes yes/no questions as well as narrative. It captures number of suicidal events as well as type and severity.
Time Frame
Baseline to 6 months
Title
Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
Suicidal events (past and over follow-up) will be assessed with the Pediatric Version of the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS has sound psychometric properties, yields ratings of widely accepted definitions of youth suicidal events, and was used in other pediatric treatment trials yielding standardized outcomes to compare across studies. This is a semi-structured interview that includes yes/no questions as well as narrative. It captures number of suicidal events as well as type and severity.
Time Frame
6 months to 12 months
Title
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Description
Youth participants will complete the Difficulties in Emotion Regulation (DERS), a 36-item questionnaire assessing emotional dysregulation. Participants indicate how often each item applies to them on a scale from 1="almost never; 0-10 percent" to 5= "almost always; 91-100 percent".
Time Frame
Baseline to 3 months
Title
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Description
Youth participants will complete the Difficulties in Emotion Regulation (DERS), a 36-item questionnaire assessing emotional dysregulation. Participants indicate how often each item applies to them on a scale from 1="almost never; 0-10 percent" to 5= "almost always; 91-100 percent".
Time Frame
3 months to 6 months
Title
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Description
Youth participants will complete the Difficulties in Emotion Regulation (DERS), a 36-item questionnaire assessing emotional dysregulation. Participants indicate how often each item applies to them on a scale from 1="almost never; 0-10 percent" to 5= "almost always; 91-100 percent".
Time Frame
6 months to 9 months
Title
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Description
Youth participants will complete the Difficulties in Emotion Regulation (DERS), a 36-item questionnaire assessing emotional dysregulation. Participants indicate how often each item applies to them on a scale from 1="almost never; 0-10 percent" to 5= "almost always; 91-100 percent".
Time Frame
9 months to 12 months
Title
Treatment Satisfaction Questionnaire (18-item)
Description
During follow-up visits, participants, parents, and/or siblings who are participating in therapy sessions will complete an 18-item Treatment Satisfaction Questionnaire. This assesses clients' satisfaction of the service (responses range from quite dissatisfied to very satisfied) as well as whether or not the service addressed the clients' needs.
Time Frame
3 months
Title
Treatment Satisfaction Questionnaire (18-item)
Description
During follow-up visits, participants, parents, and/or siblings who are participating in therapy sessions will complete an 18-item Treatment Satisfaction Questionnaire. This assesses clients' satisfaction of the service (responses range from quite dissatisfied to very satisfied) as well as whether or not the service addressed the clients' needs.
Time Frame
6 months
Title
Treatment Satisfaction Questionnaire (18-item)
Description
During follow-up visits, participants, parents, and/or siblings who are participating in therapy sessions will complete an 18-item Treatment Satisfaction Questionnaire. This assesses clients' satisfaction of the service (responses range from quite dissatisfied to very satisfied) as well as whether or not the service addressed the clients' needs.
Time Frame
9 months
Title
Treatment Satisfaction Questionnaire (18-item)
Description
During follow-up visits, participants, parents, and/or siblings who are participating in therapy sessions will complete an 18-item Treatment Satisfaction Questionnaire. This assesses clients' satisfaction of the service (responses range from quite dissatisfied to very satisfied) as well as whether or not the service addressed the clients' needs.
Time Frame
12 months
Title
Change in affective lability using the Children's Affective Lability Scale (CALS)
Description
The Children's Affective Lability Scale (CALS) is a reliable 20-item adolescent- and parent-reported measure of mood lability, derived from the adult Affective Lability Scale that was specifically designed for adults with BD. It yields a total score as well as an angry/depressed factor and a disinhibited/impersistent factor. Total scores can vary from 0 to 80, with lower scores indicating a lesser degree of affective lability.
Time Frame
Baseline to 3 months
Title
Change in affective lability using the Children's Affective Lability Scale (CALS)
Description
The Children's Affective Lability Scale (CALS) is a reliable 20-item adolescent- and parent-reported measure of mood lability, derived from the adult Affective Lability Scale that was specifically designed for adults with BD. It yields a total score as well as an angry/depressed factor and a disinhibited/impersistent factor. Total scores can vary from 0 to 80, with lower scores indicating a lesser degree of affective lability.
Time Frame
3 months to 6 months
Title
Change in affective lability using the Children's Affective Lability Scale (CALS)
Description
The Children's Affective Lability Scale (CALS) is a reliable 20-item adolescent- and parent-reported measure of mood lability, derived from the adult Affective Lability Scale that was specifically designed for adults with BD. It yields a total score as well as an angry/depressed factor and a disinhibited/impersistent factor. Total scores can vary from 0 to 80, with lower scores indicating a lesser degree of affective lability.
Time Frame
6 months to 9 months
Title
Change in affective lability using the Children's Affective Lability Scale (CALS)
Description
The Children's Affective Lability Scale (CALS) is a reliable 20-item adolescent- and parent-reported measure of mood lability, derived from the adult Affective Lability Scale that was specifically designed for adults with BD. It yields a total score as well as an angry/depressed factor and a disinhibited/impersistent factor. Total scores can vary from 0 to 80, with lower scores indicating a lesser degree of affective lability.
Time Frame
9 months to 12 months
Title
Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
Description
Youth participants will complete the DBT-WCCL, a 59-item questionnaire assessing the use of DBT skills and coping strategies. Participants indicate how often they engaged in the thought/behavior from 0= "never used" to 3= "regularly used".
Time Frame
Baseline to 3 months
Title
Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
Description
Youth participants will complete the DBT-WCCL, a 59-item questionnaire assessing the use of DBT skills and coping strategies. Participants indicate how often they engaged in the thought/behavior from 0= "never used" to 3= "regularly used".
Time Frame
3 months to 6 months
Title
Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
Description
Youth participants will complete the DBT-WCCL, a 59-item questionnaire assessing the use of DBT skills and coping strategies. Participants indicate how often they engaged in the thought/behavior from 0= "never used" to 3= "regularly used".
Time Frame
6 months to 9 months
Title
Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
Description
Youth participants will complete the DBT-WCCL, a 59-item questionnaire assessing the use of DBT skills and coping strategies. Participants indicate how often they engaged in the thought/behavior from 0= "never used" to 3= "regularly used".
Time Frame
9 months to 12 months
Title
Change in functioning using the Children's Global Assessment Scale (C-GAS)
Description
The Children's Global Assessment Scale (C-GAS) is an adaptation of the Global Assessment of Functioning Scale (GAF) developed to reflect the lowest level of functioning for a child or adolescent during a specified time period. Scores can range from 1-100, with scores above 70 designated as indicating normal functioning. This scale was found to be reliable between interviewers across time. Also, it has demonstrated both discriminant and concurrent validity.
Time Frame
Baseline to 6 months
Title
Change in functioning using the Children's Global Assessment Scale (C-GAS)
Description
The Children's Global Assessment Scale (C-GAS) is an adaptation of the Global Assessment of Functioning Scale (GAF) developed to reflect the lowest level of functioning for a child or adolescent during a specified time period. Scores can range from 1-100, with scores above 70 designated as indicating normal functioning. This scale was found to be reliable between interviewers across time. Also, it has demonstrated both discriminant and concurrent validity.
Time Frame
6 months to 12 months
Title
Change in temperament using the Conflict Behavior Questionnaire (CBQ)
Description
The Conflict Behavior Questionnaire (CBQ) is a youth and parent 20-item self-report instrument that taps into conflict and negative communication between parents and their children. Items are rated as "true" or "false". Higher scores indicate greater levels of conflict and negative communication.
Time Frame
Baseline to 3 months
Title
Change in temperament using the Conflict Behavior Questionnaire (CBQ)
Description
The Conflict Behavior Questionnaire (CBQ) is a youth and parent 20-item self-report instrument that taps into conflict and negative communication between parents and their children. Items are rated as "true" or "false". Higher scores indicate greater levels of conflict and negative communication.
Time Frame
3 months to 6 months
Title
Change in temperament using the Conflict Behavior Questionnaire (CBQ)
Description
The Conflict Behavior Questionnaire (CBQ) is a youth and parent 20-item self-report instrument that taps into conflict and negative communication between parents and their children. Items are rated as "true" or "false". Higher scores indicate greater levels of conflict and negative communication.
Time Frame
6 months to 9 months
Title
Change in temperament using the Conflict Behavior Questionnaire (CBQ)
Description
The Conflict Behavior Questionnaire (CBQ) is a youth and parent 20-item self-report instrument that taps into conflict and negative communication between parents and their children. Items are rated as "true" or "false". Higher scores indicate greater levels of conflict and negative communication.
Time Frame
9 months to 12 months
Title
Change in family functioning using the Family Adaptability and Cohesion Evaluation Scale, IV (FACES-IV)
Description
The Family Adaptability and Cohesion Evaluation Scale (FACES-IV) was developed to evaluate the adaptability and cohesion dimensions in family interactions. Youth and parents will complete this self-report questionnaire. Six scales were developed, with two balanced scales and four unbalanced scales designed to tap low and high cohesion (disengaged and enmeshed) and flexibility (rigid and chaotic). Ratio scores above 1 indicate healthier families whereas ratio scores below 1 indicate more problematic families. The six scales in FACES-IV were found to be reliable and valid. Additionally, high levels of concurrent, construct, and discriminant validity were found.
Time Frame
Baseline to 3 months
Title
Change in family functioning using the Family Adaptability and Cohesion Evaluation Scale, IV (FACES-IV)
Description
The Family Adaptability and Cohesion Evaluation Scale (FACES-IV) was developed to evaluate the adaptability and cohesion dimensions in family interactions. Youth and parents will complete this self-report questionnaire. Six scales were developed, with two balanced scales and four unbalanced scales designed to tap low and high cohesion (disengaged and enmeshed) and flexibility (rigid and chaotic). Ratio scores above 1 indicate healthier families whereas ratio scores below 1 indicate more problematic families. The six scales in FACES-IV were found to be reliable and valid. Additionally, high levels of concurrent, construct, and discriminant validity were found.
Time Frame
3 months to 6 months
Title
Change in family functioning using the Family Adaptability and Cohesion Evaluation Scale, IV (FACES-IV)
Description
The Family Adaptability and Cohesion Evaluation Scale (FACES-IV) was developed to evaluate the adaptability and cohesion dimensions in family interactions. Youth and parents will complete this self-report questionnaire. Six scales were developed, with two balanced scales and four unbalanced scales designed to tap low and high cohesion (disengaged and enmeshed) and flexibility (rigid and chaotic). Ratio scores above 1 indicate healthier families whereas ratio scores below 1 indicate more problematic families. The six scales in FACES-IV were found to be reliable and valid. Additionally, high levels of concurrent, construct, and discriminant validity were found.
Time Frame
6 months to 9 months
Title
Change in family functioning using the Family Adaptability and Cohesion Evaluation Scale, IV (FACES-IV)
Description
The Family Adaptability and Cohesion Evaluation Scale (FACES-IV) was developed to evaluate the adaptability and cohesion dimensions in family interactions. Youth and parents will complete this self-report questionnaire. Six scales were developed, with two balanced scales and four unbalanced scales designed to tap low and high cohesion (disengaged and enmeshed) and flexibility (rigid and chaotic). Ratio scores above 1 indicate healthier families whereas ratio scores below 1 indicate more problematic families. The six scales in FACES-IV were found to be reliable and valid. Additionally, high levels of concurrent, construct, and discriminant validity were found.
Time Frame
9 months to 12 months
Title
Number, frequency, and type of therapy sessions
Description
The Therapy Tracking Form will be used to document the date of the therapy session, type of session, session duration, content, and scheduled date for next therapy visit. This form will be completed by the study therapist after each therapy session.
Time Frame
At the end of study completion (five years)
Secondary Outcome Measure Information:
Title
Childhood Trust Events Survey (CTES)
Description
Youth will complete the Childhood Trust Events Survey (CTES) long-form, adolescent version, a 30-item self-report screening survey that assesses exposure to adversity across a breadth of domains including physical, emotional, and sexual abuse; alcohol/drug users in home; family members in prison; caregiver with mental illness; domestic violence; loss/separation from caregiver; and other traumatic events. In addition, the CTES queries the age and perceived intensity of each type of adversity. Parents will complete the caregiver version of the CTES, a 26-item survey that asks if their child has been exposed to the same domains of adversity as queried in the adolescent version.
Time Frame
Baseline
Title
Change in parental psychological distress using the Symptom Checklist-90 (SCL-90)
Description
The Symptom Checklist-90 (SCL-90) is 90-item parent-reported measure used to assess symptoms and complaints that parents may have. It assesses the following dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and other.
Time Frame
Baseline to 3 months
Title
Change in parental psychological distress using the Symptom Checklist-90 (SCL-90)
Description
The Symptom Checklist-90 (SCL-90) is 90-item parent-reported measure used to assess symptoms and complaints that parents may have. It assesses the following dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and other.
Time Frame
3 months to 6 months
Title
Change in parental psychological distress using the Symptom Checklist-90 (SCL-90)
Description
The Symptom Checklist-90 (SCL-90) is 90-item parent-reported measure used to assess symptoms and complaints that parents may have. It assesses the following dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and other.
Time Frame
6 months to 9 months
Title
Change in parental psychological distress using the Symptom Checklist-90 (SCL-90)
Description
The Symptom Checklist-90 (SCL-90) is 90-item parent-reported measure used to assess symptoms and complaints that parents may have. It assesses the following dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and other.
Time Frame
9 months to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English-speaking Age 13 years, 0 months to 23 years, 11 months Meet diagnostic criteria for BD by KSADS-PL OR have a biological parent/sibling with BD (type I or II) confirmed via KSADS-PL or SCID-5-RV If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium) Followed by a CAMH psychiatrist who provides ongoing care At least 1 lifetime suicide attempt (actual, interrupted, and/or aborted as measured by the C-SSRS) -OR- ≥ 3 lifetime non-suicidal self-injurious (NSSI) behaviors, with one behavior occurring in the past 3 months (as measured by the C-SSRS and ALIFE) -OR- a score of ≥ 24 on the SIQ -OR- 6b) Severe emotion dysregulation (score of ≥ 105 on DERS or score of ≥ 20 on the CALS (youth report) -OR- Meet youth threshold for at least 2 impulsive behavior categories on question #4 from the SIDP-IV or 1 category is identified as severe (through case discussion that will focus on level of risk, persistence, and impairment) Able and willing to give informed consent/assent to participate Exclusion Criteria: Evidence of mental retardation, moderate to severe pervasive developmental disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records A life-threatening medical condition requiring immediate treatment Current victim of sexual or physical abuse Current substance use disorder other than mild cannabis or alcohol use disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Roane, MSW
Phone
416-535-8501
Ext
31759
Email
jessica.roane@camh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Omrin, MSW
Phone
416-535-8501
Ext
31760
Email
danielle.omrin@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin I Goldstein, MD, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Roane, MSW
Phone
416-535-8501
Ext
31759
Email
jessica.roane@camh.ca
First Name & Middle Initial & Last Name & Degree
Danielle Omrin, MSW
Phone
416-535-8501
Ext
31760
Email
danielle.omrin@camh.ca
First Name & Middle Initial & Last Name & Degree
Benjamin I Goldstein, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Dialectical Behavior Therapy for Youth With and/or at Familial Risk for Bipolar Disorder

We'll reach out to this number within 24 hrs