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

NCT05153382 | Recruiting DMC

• 1 other identifier: 049/2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Youth; Dialectical Behavior Therapy (DBT)

Outcome Measures

Primary Outcomes (41)

• 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.

  Baseline to 6 months

• 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.

  6 months to 12 months

• 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").

  Baseline to 3 months

• 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").

  3 months to 6 months

• 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").

  6 months to 9 months

• 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").

  9 months to 12 months

• 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.

  Baseline to 3 months

• 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.

  3 months to 6 months

• 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.

  6 months to 9 months

• 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.

  9 months to 12 months

• 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.

  Baseline to 6 months

• 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.

  6 months to 12 months

• 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.

  Baseline to 6 months

• 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.

  6 months to 12 months

• 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".

  Baseline to 3 months

• 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".

  3 months to 6 months

• 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".

  6 months to 9 months

• 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".

  9 months to 12 months

• 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.

  3 months

• 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.

  6 months

• 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.

  9 months

• 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.

  12 months

• 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.

  Baseline to 3 months

• 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.

  3 months to 6 months

• 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.

  6 months to 9 months

• 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.

  9 months to 12 months

• 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".

  Baseline to 3 months

• 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".

  3 months to 6 months

• 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".

  6 months to 9 months

• 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".

  9 months to 12 months

• Change in functioning using the Children's Global Assessment Scale (C-GAS) or Global Assessment of Functioning (GAF)

  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.

  Baseline to 6 months

• Change in functioning using the Children's Global Assessment Scale (C-GAS) or Global Assessment of Functioning (GAF)

  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.

  6 months to 12 months

• 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.

  Baseline to 3 months

• 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.

  3 months to 6 months

• 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.

  6 months to 9 months

• 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.

  9 months to 12 months

• 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.

  Baseline to 3 months

• 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.

  3 months to 6 months

• 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.

  6 months to 9 months

• 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.

  9 months to 12 months

• 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.

  At the end of study completion (five years)

Secondary Outcomes (5)

• Childhood Trust Events Survey (CTES)

  Baseline

• Change in parental psychological distress using the Symptom Checklist-90 (SCL-90)

  Baseline to 3 months

• Change in parental psychological distress using the Symptom Checklist-90 (SCL-90)

  3 months to 6 months

• Change in parental psychological distress using the Symptom Checklist-90 (SCL-90)

  6 months to 9 months

• Change in parental psychological distress using the Symptom Checklist-90 (SCL-90)

  9 months to 12 months

Study Arms (1)

Youth with and/or at familial risk for bipolar disorder

EXPERIMENTAL

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

Behavioral: Dialectical behavioral therapy

Interventions

Dialectical behavioral therapy BEHAVIORAL

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.

Also known as: DBT

Youth with and/or at familial risk for bipolar disorder

Eligibility Criteria

• Age: 13 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Benjamin I Goldstein, MD, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Rajamani, MSW

CONTACT

416-535-8501; vanessa.rajamani@camh.ca

Amanda Moss, MSW

CONTACT

416-535-8501; amanda.moss@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Centre for Youth Bipolar Disorder, Clinician-Scientist, Professor of Psychiatry, Pharmacology & Toxicology, and Psychological Clinical Science

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 10, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

CA (1)