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

Study acronym: DB3
StatusRecruiting
PhaseNot applicable
Started2021-11-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 23 months later Mar 2026 → Mar 2028
See other at-risk trials from Centre for Addiction and Mental Health

Amendment history

2026-10-02
Primary completion pushed: 2026-03 → 2028-03
Completion pushed: 2026-03 → 2029-03
2025-11-17
Study Status v7
Re-verified, no change to tracked fields
2025-04-09
Study Status, Eligibility, Contacts/Locations v6
Eligibility criteriarevised
[...] iteria for BD by KSADS-PL (< 20 years of age) or SCID-5-RV (>≥ 20 years of age) OR have a biological parent/sibling with B [...]
Study sitescontacts updated at 1 of 1 site
2024-07-30
Study Status, Contacts/Locations v5
Study sitescontacts updated at 1 of 1 site
2024-05-29
Study Status, Eligibility v4
Eligibility criteria+73 characters
[...] s, 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) [...] or organic central nervous system disorder by the K-SADS-PL (< 20 years of age), parent report, medical history, or school records that wou [...]
Show 3 earlier versions
2024-04-17
Study Status, Arms and Interventions, Eligibility v3
Eligibility criteria+39 characters
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 OR have a biolog [...] g 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 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 autism sp [...] ecords that would interfere with active participation in [...]
2023-07-11
Study Status, Contacts/Locations v2
Study sitescontacts updated at 1 of 1 site
2023-05-11
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Eligibility criteria+141 characters
[...] years, 11 months Meet diagnostic criteria for BD by KSADS-PL OR have a biological parent/sibling with BD (type I or II) confirmed via KSADS-PL or SCID-5-RV If BD-I, taking ≥1 mood stabilizing medication (i.e., antim [...] riteria: Evidence of mental retardation, moderate to severe pervasiveautism developmentalspectrum disorder, or organic central nervous system disorder by the [...] K-SADS-PL, parent report, medical history, or school records that would interfere with active participation in DBT A life-threatening medical condition requiring immediate tr [...]
Secondary endpoints2 to 1 entries
ChangeAdherence inscore riskfor behaviors/riskDBT factorsbooster sessions measured using thea Safetymodified Assessment Changeversion in risk behaviors/risk factors usingof the SafetyDialectical AssessmentBehavior Therapy Adherence Checklist - Individual Therapy
Study sitescontacts updated at 1 of 1 site
Study title+7 characters
Personalized and Pragmatic Three-level Model of DBT-informed Care for Youth With and/or at Familial Risk for Bipolar Disorder (DB3)
2021-11-30
Original filing
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.
Trial Details
NCT Number NCT05153369
Lead Sponsor Centre for Addiction and Mental Health
Conditions Bipolar Disorder
Enrollment 60 participants
Start Date 2021-11-01
Primary Completion 2028-03 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2026-10-01