We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 247 for:    pragmatic | Canada

Personalized and Pragmatic Three-level Model of DBT-informed Care for Youth With Bipolar Disorder (DB3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05153369
Recruitment Status : Recruiting
First Posted : December 10, 2021
Last Update Posted : December 10, 2021
Sponsor:
Information provided by (Responsible Party):
Benjamin Goldstein, Centre for Addiction and Mental Health

Brief Summary:
This study seeks to bridge the knowledge-to-action gap regarding psychosocial treatment "dosing" for youth with bipolar disorder (BD). In psychiatry, pragmatic collaborative decisions between patient and care provider about pharmacological titrations and tapers are common. Less frequently are there considerations made regarding the pragmatic dosing of psychosocial interventions. Whereas some youth clearly require full/"high-dose" treatment, others may benefit from "lower-dose" interventions, alongside re-evaluation of dosing needs over time. Furthermore, there is a subset of youth who do not require or do not want the intensity and frequency of treatment that current interventions provide. This research presents a unique opportunity to better understand different levels of care within a subspecialized outpatient mental health clinic serving youth with BD who vary greatly in terms of risk indicators, type and severity of symptoms, associated distress, and compounding functional impairment.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Behavioral: Enhanced Care Behavioral: DBT Skills Training Behavioral: Dialectical Behavior Therapy Full Intervention Not Applicable

Detailed Description:
Bipolar disorder (BD) in adolescence is associated with poor outcomes, including impaired psychosocial functioning, substance use, and suicidality. Preliminary data using DBT as a treatment for youth BD shows improvement in depression symptoms and suicidality. At the same time, the reality is that BD is a chronic disease, and it stands to reason that a pragmatic, adaptive management approach is warranted. Developing a multi-level DBT-informed approach is advantageous for a number of reasons, in particular because this approach embraces clinical heterogeneity within and between individuals. Whereas some youth clearly require full/"high-dose" treatment, others may benefit from judicious use of "lower-dose" interventions, alongside re-evaluation of dosing needs over time. Furthermore, there is a subset of youth who do not require and/or do not want the intensity and frequency of treatment that current interventions provide. Thus far, the leading evidence-based psychosocial treatment studies in the field of youth BD have taken an "all or nothing" approach and have only been studied at one dosing level. While such an approach has certain advantages, it lacks person-centered consideration regarding pragmatic dosing. This study endeavors to determine the feasibility and effectiveness of a multi-level treatment model with dosing decisions driven by a combination of risk indicators and symptom severity (with an emphasis on emotional dysregulation, suicidality, and functional impairment; key treatment targets in dialectical behavior therapy), along with patient preference. This study proposes to implement three intensity levels of dialectical behavior therapy (DBT)-informed intervention that differ in regards to the number and frequency of sessions, parental involvement, and treatment components. This research will seek to understand the outcomes of three different levels of therapy and will examine what factors lead to the escalation of DBT dosing levels in this population.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This study is targeted toward youth with BD who, at intake, do not want and/or require full DBT. Participants will be enrolled into Level 1 - Enhanced Care or Level 2 - DBT Skills Training; for those whose circumstances change during the course of the study, such that they want and/or require full dose DBT, the intervention also includes potential dose escalation up through Level 3 - DBT Full Intervention. As the levels escalate, frequency of therapy sessions and contact with study therapist will increase. Dosing decisions will be driven by a combination of risk indicators and symptom severity, with an emphasis on emotional dysregulation, suicidality, and functional impairment, along with patient preference. Participants who are initially enrolled into Levels 1 or 2 will be able to escalate to Level 3 up until the end of their first year of enrollment. This is to ensure that they will have time to receive one full year of the DBT intervention.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Personalized and Pragmatic Three-level Model of DBT-informed Care for Youth With Bipolar Disorder
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Level 1
At enrollment, participants will be categorized according to suicidality, emotion dysregulation, risk behaviors, and participant preference. Participants with no lifetime suicidal behaviors and ideations will be enrolled in Level 1. Participants with a score of < 73 on the DERS AND a score of ≤ 8 on the CALS (youth report) will be enrolled in Level 1.
Behavioral: Enhanced Care
Enhanced care aims to educate participants about bipolar disorder using a didactic approach, in addition to teaching and practicing DBT skills in an applied and relevant manner based on the participant's needs. Participants will receive a total of four sessions (approx. 60 minutes in duration), to occur once a month, at a minimum. The content will be split up into psychoeducation (2 sessions) and selected DBT skills (2 sessions). Psychoeducation will be specific to youth bipolar disorder, covering topics such as symptoms of depression and hypo/mania, medications used to treat bipolar disorder, the role of biology and the environment in emotions, and vulnerability and protective factors to emotion dysregulation and mood episodes. The content of skills sessions will be individualized and based on participant needs and goals (e.g., learning and applying skills to optimize their overall functioning, address problem behaviors and/or stressors, and/or maintain commitment to treatment).

Experimental: Level 2
At enrollment, participants will be categorized according to suicidality, emotion dysregulation, risk behaviors, and participant preference. Participants with < 3 lifetime non-suicidal self-injurious (NSSI) behaviors with one behavior occurring in the past 3 months or ≥ 3 lifetime NSSI behaviors with none in the past 3 months AND no lifetime suicide attempts (actual, interrupted and/or aborted) AND a score of ≥ 16 and < 24 on the SIQ AND lifetime suicidal ideations will be enrolled in Level 2. Participants with a score of ≥ 73 and < 105 on the DERS OR a score of > 8 and < 20 on the CALS (youth report) will be enrolled in Level 2.
Behavioral: DBT Skills Training
In DBT Skills Training, participants will only receive skills training and can choose to do this individually and/or with their individual family unit by including their parent(s) and/or sibling(s). Participants will receive 15-20 sessions (approx. 60 minutes in duration), to occur at least biweekly. Skills training will include the five standard youth DBT modules: psychoeducation about DBT and bipolar disorder, mindfulness, distress tolerance, emotion regulation, interpersonal effectiveness, and walking the middle path. The primary focus of the skills training is to impart knowledge and acquire and strengthen pragmatic skills to replace dysfunctional behaviors. If participants choose to include their family members, they will be encouraged to coach one another in effective use of skills.

Experimental: Level 3
At enrollment, participants will be categorized according to suicidality, emotion dysregulation, risk behaviors, and participant preference. Participants with at least 1 lifetime suicide attempt (actual, interrupted, and/or aborted) OR ≥ 3 lifetime NSSI behaviors, with one behavior occurring in the past 3 months OR a score of ≥ 24 on the SIQ will be enrolled in Level 3. Participants with a score of ≥ 105 on the DERS OR a score of ≥ 20 on the CALS (youth report) will be enrolled in Level 3. Participants who meet youth threshold for at least 2 impulsive behavior categories on question #4 from the SIDP-IV or 1 category is identified as severe will be enrolled in Level 3.
Behavioral: Dialectical Behavior Therapy Full Intervention
The DBT full intervention is based on Miller et al.'s DBT for suicidal youth, with modifications for youth with BD. Participants will receive the full 1-year DBT intervention (approx. 40 sessions) alternating between individual and skills training sessions. Family involvement in skills training will be strongly encouraged, however will be up to the participant to decide. Participants in Level 3 will complete diary cards tailored for this population, assessing daily mood, suicidality, sleep, and medication adherence. Participants will report use of specified DBT skills on the diary card, and individualized treatment goals will be incorporated into the diary card (e.g., alcohol use). In addition, Level 3 will include skills coaching by phone (via phone and/or text). These brief, structured calls and/or texts function to promote skills generalization by helping the participant and any participating family member(s) use skills to achieve goals and solve problems.




Primary Outcome Measures :
  1. Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder [ Time Frame: 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.

  2. Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder [ Time Frame: 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.

  3. Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder [ Time Frame: 12 months to 18 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.

  4. Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder [ Time Frame: 18 months to 24 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.

  5. Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: 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").

  6. Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: 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").

  7. Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: 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").

  8. Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: 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").

  9. Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: 12 months to 15 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").

  10. Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: 15 months to 18 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").

  11. Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: 18 months to 21 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").

  12. Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: 21 months to 24 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").

  13. Change in suicidality Suicidal Ideation Questionnaire (SIQ) [ Time Frame: Baseline to 3 months ]
    Youth participants will complete the self-report Suicidal Ideation Questionnaire (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.

  14. Change in suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: 3 months to 6 months ]
    Youth participants will complete the self-report Suicidal Ideation Questionnaire (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.

  15. Change in suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: 6 months to 9 months ]
    Youth participants will complete the self-report Suicidal Ideation Questionnaire (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.

  16. Change in suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: 9 months to 12 months ]
    Youth participants will complete the self-report Suicidal Ideation Questionnaire (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.

  17. Change in suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: 12 months to 15 months ]
    Youth participants will complete the self-report Suicidal Ideation Questionnaire (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.

  18. Change in suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: 15 months to 18 months ]
    Youth participants will complete the self-report Suicidal Ideation Questionnaire (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.

  19. Change in suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: 18 months to 21 months ]
    Youth participants will complete the self-report Suicidal Ideation Questionnaire (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.

  20. Change in suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: 21 months to 24 months ]
    Youth participants will complete the self-report Suicidal Ideation Questionnaire (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.

  21. Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE) [ Time Frame: 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.

  22. Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE) [ Time Frame: 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.

  23. Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE) [ Time Frame: 12 months to 18 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.

  24. Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE) [ Time Frame: 18 months to 24 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.

  25. Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 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.

  26. Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 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.

  27. Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 12 months to 18 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.

  28. Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 18 months to 24 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.

  29. Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: Baseline to 3 months ]
    Youth participants will complete the Difficulties in Emotion Regulation Scale (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".

  30. Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 3 months to 6 months ]
    Youth participants will complete the Difficulties in Emotion Regulation Scale (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".

  31. Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 6 months to 9 months ]
    Youth participants will complete the Difficulties in Emotion Regulation Scale (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".

  32. Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 9 months to 12 months ]
    Youth participants will complete the Difficulties in Emotion Regulation Scale (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".

  33. Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 12 months to 15 months ]
    Youth participants will complete the Difficulties in Emotion Regulation Scale (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".

  34. Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 15 months to 18 months ]
    Youth participants will complete the Difficulties in Emotion Regulation Scale (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".

  35. Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 18 months to 21 months ]
    Youth participants will complete the Difficulties in Emotion Regulation Scale (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".

  36. Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 21 months to 24 months ]
    Youth participants will complete the Difficulties in Emotion Regulation Scale (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".

  37. Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 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.

  38. Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 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.

  39. Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 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.

  40. Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 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.

  41. Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 15 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.

  42. Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 18 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.

  43. Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 21 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.

  44. Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 24 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.

  45. Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: 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.

  46. Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: 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.

  47. Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: 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.

  48. Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: 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.

  49. Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: 12 months to 15 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.

  50. Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: 15 months to 18 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.

  51. Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: 18 months to 21 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.

  52. Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: 21 months to 24 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.

  53. Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: 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".

  54. Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: 3 months to 6 months ]
    Youth participants will complete the DBT Ways of Coping Checklist (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".

  55. Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: 6 months to 9 months ]
    Youth participants will complete the DBT Ways of Coping Checklist (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".

  56. Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: 9 months to 12 months ]
    Youth participants will complete the DBT Ways of Coping Checklist (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".

  57. Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: 12 months to 15 months ]
    Youth participants will complete the DBT Ways of Coping Checklist (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".

  58. Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: 15 months to 18 months ]
    Youth participants will complete the DBT Ways of Coping Checklist (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".

  59. Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: 18 months to 21 months ]
    Youth participants will complete the DBT Ways of Coping Checklist (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".

  60. Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: 21 months to 24 months ]
    Youth participants will complete the DBT Ways of Coping Checklist (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".

  61. Childhood Trust Events Survey (CTES) [ Time Frame: Baseline ]
    Youth will complete the 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.

  62. Number, frequency, and type of therapy sessions [ Time Frame: At the end of study completion (5 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.


Secondary Outcome Measures :
  1. Change in risk behaviors/risk factors using the Safety Assessment [ Time Frame: Baseline to 12 months ]
    The Safety Assessment form is used to collect information on lifetime risk behavior/risk factors including legal & aggression history, sexual activity, abuse history, household firearms and risk assessment.

  2. Change in risk behaviors/risk factors using the Safety Assessment [ Time Frame: 12 months to 24 months ]
    The Safety Assessment form is used to collect information on lifetime risk behavior/risk factors including legal & aggression history, sexual activity, abuse history, household firearms and risk assessment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  4. If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium)
  5. Followed by a CAMH psychiatrist who provides ongoing care
  6. Able and willing to give informed consent/assent to participate

Exclusion Criteria:

  1. 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
  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
  5. Meets assessment criteria for Level 3 at enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05153369


Contacts
Layout table for location contacts
Contact: Danielle Omrin, MSW 416-535-8501 danielle.omrin@camh.ca
Contact: Jessica Roane, MSW 416-535-8501 jessica.roane@camh.ca

Locations
Layout table for location information
Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M6J 1H4
Contact: Jessica Roane, MSW    416-535-8501 ext 31759    jessica.roane@camh.ca   
Contact: Danielle Omrin, MSW    416-535-8501 ext 31760    danielle.omrin@camh.ca   
Principal Investigator: Benjamin I Goldstein, MD, PhD         
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Layout table for investigator information
Principal Investigator: Benjamin I Goldstein, MD, PhD Centre for Addiction and Mental Health
Layout table for additonal information
Responsible Party: Benjamin Goldstein, Director of the Centre for Youth Bipolar Disorder, Clinician-Scientist, Professor of Psychiatry, Pharmacology & Toxicology, and Psychological Clinical Science, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT05153369    
Other Study ID Numbers: 009/2021
First Posted: December 10, 2021    Key Record Dates
Last Update Posted: December 10, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benjamin Goldstein, Centre for Addiction and Mental Health:
Youth
Dialectical Behavior Therapy (DBT)
Additional relevant MeSH terms:
Layout table for MeSH terms
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders