Clinical trial NCT03661333: Dissemination and Implementation Field Trial of Dialectical Behavior Therapy for Adolescents With Bipolar Disorder
Official title: Dissemination and Implementation Field Trial of Dialectical Behavior Therapy for Adolescents With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: dialectical behavior therapy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2018-09-07
Enrollment: 21
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overarching goal of this project is to evaluate the feasibility of implementing dialectical behavior therapy DBT for adolescents with bipolar disorder in an outpatient mental health clinic. In collaboration with the University of Pittsburgh, this study will measure study therapists' knowledge of the DBT model, adherence to the treatment model, and satisfaction with the treatment model.

Detailed description: This study proposes to implement dialectical behavior therapy (DBT) for adolescents with bipolar disorder (BD) in an outpatient mental health clinic serving youth with bipolar spectrum disorders. In collaboration with the University of Pittsburgh, this study will systemically operationalize, implement, and examine the specific training, supervision, and programmatic systems needed to successfully implement and sustain the intervention in an adherent manner to achieve positive patient outcomes. This study therefore presents a unique opportunity to enhance understanding of the necessary procedures for implementing the treatment in the community, while allowing us to examine effectiveness of the intervention at the community level.

Aim 1: To examine the short- and longer-term feasibility and acceptability of a training program in DBT for adolescents with BD through clinician satisfaction ratings.

Aim 2: To examine the short- and longer-term effects of the training on practitioner knowledge and performance, and patient outcomes.

Eligibility criteria: Inclusion Criteria:

* English-speaking
* Age 13 years, 0 months to 19 years, 11 months
* Meet diagnostic criteria for BD by KSADS-PL
* Engaged in, or willing to proceed with, a pharmacotherapy regimen
* At least one parent/guardian with whom the patient lives or regularly interacts (\>5 hours per week) is willing to participate in skills training
* Able and willing to give informed consent/assent to participate.

Exclusion Criteria:

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

Primary outcomes:
measure: Therapist satisfaction and acceptability
timeFrame: Baseline
measure: Therapist satisfaction and acceptability
timeFrame: 6 months
measure: therapists will adhere to the DBT Adherence Rating Scale
timeFrame: End of study year 2
measure: Therapists will obtain a passing grade of the DBT Certification Exam
timeFrame: 1 year
measure: Therapist satisfaction and acceptability
timeFrame: 12 months
measure: Therapist satisfaction and acceptability
timeFrame: 24 months
Secondary outcomes:
measure: Change in symptoms using the Longitudinal Interval Follow-up Evaluation (LIFE)
timeFrame: Baseline to 6 months
measure: Change in symptoms using the Longitudinal Interval Follow-up Evaluation (LIFE)
timeFrame: 6 months to 12 months
measure: Schedule for Affective Disorders and Schizophrenia for School Age Children, Present and Life Version (K-SADS-PL)
timeFrame: Baseline
measure: K-SADS Mania Rating Scale (MRS)
timeFrame: Baseline
measure: Depression section of the K-SADS-Present Episode Version (K-SADS-Dep)
timeFrame: Baseline
measure: Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS)
timeFrame: Baseline to 3 months
measure: Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS)
timeFrame: 3 months to 6 months
measure: Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS)
timeFrame: 6 months to 9 months
measure: Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS)
timeFrame: 9 months to 12 months
measure: Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline to 6 months
measure: Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 6 months to 12 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: Baseline to 3 months,
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: 3 months to 6 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: 6 months to 9 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: 9 months to 12 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: Baseline to 3 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 3 months to 6 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 6 months to 9 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 9 months to 12 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline to 3 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 3 months to 6 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 6 months to 9 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 9 months to 12 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 12 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 3 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 6 months
measure: Change in symptoms using the Structured Interview for DSM-IV Personality (SIDP-IV): Borderline Personality Disorder
timeFrame: Baseline to 6 months
measure: Change in symptoms using the Structured Interview for DSM-IV Personality (SIDP-IV): Borderline Personality Disorder
timeFrame: 6 months to 12 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: Baseline to 3 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: 3 months to 6 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: 6 months to 9 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: 9 months to 12 months
measure: Dialectical Behavior Therapy Barriers to Implementation
timeFrame: Baseline to 6 months
measure: Dialectical Behavior Therapy Barriers to Implementation
timeFrame: 6 months to 12 months
measure: Dialectical Behavior Therapy Barriers to Implementation
timeFrame: 12 months to 24 months
measure: Barriers and Facilitators Assessment Instrument (name of scale)
timeFrame: Baseline to 6 months
measure: Barriers and Facilitators Assessment Instrument (name of scale)
timeFrame: 6 months to 12 months
measure: Barriers and Facilitators Assessment Instrument (name of scale)
timeFrame: 12 months to 24 months
measure: Implementation Climate Scale
timeFrame: Baseline to 6 months
measure: Implementation Climate Scale
timeFrame: 6 months to 12 months
measure: Implementation Climate Scale
timeFrame: 12 months to 24 months
measure: Change in therapist self-assessment
timeFrame: Every month for two years through study completion, an average 24 months.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Research Insitute
name: Benjamin I Goldstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: