Dialectical behavioral therapy: 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.
Study 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.
Eligibility
Sex
ALL
Min age
13 Years
Max age
23 Years
Healthy volunteers
No
Inclusion Criteria:
1\) English-speaking; 2) Age 13 years, 0 months to 23 years, 11 months; 3) Meet diagnostic criteria for BD by KSADS-PL (\< 20 years of age) or SCID-5-RV (\> 20 years of age) OR have a biological parent/sibling with BD (type I or II) confirmed via KSADS-PL or SCID-5-RV; 4) If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium); 5) Followed by a psychiatrist who provides ongoing care; 6a) At least 1 suicide attempt in the past year (actual, interrupted, and/or aborted as measured by the C-SSRS) OR at least 1 preparatory act or behavior in the past year as measured by the C-SSRS OR non-suicidal self-injurious (NSSI) behaviors in the past 3 months (as measured by the C-SSRS) -OR- 6b) 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); 7) Able and willing to give informed consent/assent to participate.
Exclusion Criteria:
1\) Evidence of mental retardation, moderate to severe autism spectrum disorder, or organic central nervous system disorder by the K-SADS-PL (\< 20 years of age), parent report, medical history, or school records that would interfere with active participation in DBT; 2) A life-threatening medical condition requiring immediate treatment; 3) Current victim of sexual or physical abuse; 4) Current substance use disorder other than mild cannabis or alcohol use disorder.
Primary outcome measure(s)
Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder — Baseline to 6 months 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 — 6 months to 12 months 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) — Baseline to 3 months 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) — 3 months to 6 months 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) — 6 months to 9 months 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) — 9 months to 12 months 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) — Baseline to 3 months 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) — 3 months to 6 months 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) — 6 months to 9 months 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) — 9 months to 12 months 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) — Baseline to 6 months 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) — 6 months to 12 months 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) — Baseline to 6 months 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) — 6 months to 12 months 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) — Baseline to 3 months 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) — 3 months to 6 months 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) — 6 months to 9 months 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) — 9 months to 12 months 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) — 3 months 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) — 6 months 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) — 9 months 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) — 12 months 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) — Baseline to 3 months 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) — 3 months to 6 months 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) — 6 months to 9 months 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) — 9 months to 12 months 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) — Baseline to 3 months 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) — 3 months to 6 months 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) — 6 months to 9 months 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) — 9 months to 12 months 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) or Global Assessment of Functioning (GAF) — Baseline to 6 months 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. This will be completed for participants aged 19 and younger.
The GAF is a scale originally included in the Diagnostic and Statistical Manual of Mental Disorders (DSM; 4th edition), and is used to rate adult participants' lowest and highest level of functioning in the past year, as well as their current level. It has been found to be reliable and valid. This will be completed for participants aged 20 and older.
Change in functioning using the Children's Global Assessment Scale (C-GAS) or Global Assessment of Functioning (GAF) — 6 months to 12 months 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. This will be completed for participants aged 19 and younger.
The GAF is a scale originally included in the Diagnostic and Statistical Manual of Mental Disorders (DSM; 4th edition), and is used to rate adult participants' lowest and highest level of functioning in the past year, as well as their current level. It has been found to be reliable and valid. This will be completed for participants aged 20 and older.
Change in temperament using the Conflict Behavior Questionnaire (CBQ) — Baseline to 3 months 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) — 3 months to 6 months 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) — 6 months to 9 months 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) — 9 months to 12 months 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) — Baseline to 3 months 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) — 3 months to 6 months 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) — 6 months to 9 months 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) — 9 months to 12 months 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 — At the end of study completion (five years) 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.
Trial sites (1)
Facility
City
Region
Status
Centre for Addiction and Mental Health
Toronto
Ontario
Recruiting
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