Actively Recruiting

Phase Not Applicable
Age: 13Years - 23Years
All Genders
NCT05153369

Three-level Model of DBT-informed Care for Youth With and/or at Familial Risk for Bipolar Disorder (DB3)

Led by Centre for Addiction and Mental Health · Updated on 2025-11-19

60

Participants Needed

1

Research Sites

225 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study seeks to bridge the knowledge-to-action gap regarding psychosocial treatment "dosing" for youth with and/or at familial risk for 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 and/or at familial risk for BD who vary greatly in terms of risk indicators, type and severity of symptoms, associated distress, and compounding functional impairment.

CONDITIONS

Official Title

Three-level Model of DBT-informed Care for Youth With and/or at Familial Risk for Bipolar Disorder (DB3)

Who Can Participate

Age: 13Years - 23Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • English-speaking
  • Age 13 years, 0 months to 23 years, 11 months
  • Meet diagnostic criteria for bipolar disorder by KSADS-PL (under 20 years) or SCID-5-RV (20 years or older) OR have a biological parent or sibling with bipolar disorder type I or II confirmed by KSADS-PL or SCID-5-RV
  • If diagnosed with bipolar I disorder, taking at least one mood stabilizing medication (antimanic anticonvulsant, antipsychotic, and/or lithium)
  • Followed by a psychiatrist who provides ongoing care
  • Able and willing to give informed consent or assent to participate
Not Eligible

You will not qualify if you...

  • Evidence of mental retardation, moderate to severe autism spectrum disorder, or organic central nervous system disorder that would interfere with active participation in DBT
  • A life-threatening medical condition requiring immediate treatment
  • Current victim of sexual or physical abuse
  • Current substance use disorder other than mild cannabis or alcohol use disorder
  • Meets assessment criteria for Level 3 at enrollment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Centre for Addiction and Mental Health

Toronto, Ontario, Canada, M6J 1H4

Actively Recruiting

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Research Team

A

Amanda Moss, MSW

CONTACT

D

Danielle Curcio, MSW

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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