Actively Recruiting
iCARE 2.0: A Pilot Intervention of Dialectical Behavioural Therapy for Youth With Type 2 Diabetes
Led by Dr. Brandy Wicklow · Updated on 2024-06-07
60
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Dr. Brandy Wicklow
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a program to help Indigenous youth aged 14 to 22 living with Type 2 Diabetes (T2D), focusing on reducing kidney disease risks by combining Dialectical Behavioural Therapy (DBT) with traditional Indigenous medicine practices. This pilot study aims to test the feasibility, acceptability, and potential benefits of this mental health intervention, addressing health disparities and supporting youth mental wellness, medication adherence, and diabetes control. Participants will be randomly assigned to either a DBT skills training group or a control group receiving standard medical care. The DBT program includes weekly 90-minute sessions over 16 weeks, delivered virtually via Zoom or in person when possible, focusing on emotional regulation and mindfulness. A second pilot will explore adding traditional medicine components developed with Indigenous advisors, but currently only the first pilot is approved. During the study, participants and their caregivers will complete surveys and interviews before, after, and three months following the intervention to assess outcomes like quality of life, glycemic control, and kidney health. Researchers will monitor adherence, retention, and participant experiences, including mental health checks throughout. The study lasts about one year per pilot, with safety and adverse events carefully tracked, including any mental health emergencies or complications from required blood draws.
CONDITIONS
Brief Title
iCARE 2.0: A Pilot Intervention of Dialectical Behavioural Therapy for Youth With Type 2 Diabetes.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Youth aged 14 to 22 years old living with youth-onset Type 2 Diabetes
- Participants must be willing to be randomized to either the DBT intervention or control group
- One caregiver per participant may be involved in the study
- Participants must be able to provide informed assent or consent voluntarily
You will not qualify if you...
- Diagnosis of diabetes other than Type 2, including Type 1, genetic, cystic fibrosis-related, or medication-induced diabetes
- History of any cancer
- Presence of other chronic illnesses linked to systemic inflammation, such as juvenile rheumatoid arthritis or Crohn's disease
- Active psychotic disorder
- Suicide attempt or active plan within the past year
- Self-reported substance or alcohol use disorder in the past year
- Inability or unwillingness of participant or caregiver to provide informed assent or consent
- Currently pregnant (eligible only after 3 months postpartum)
- Significant self-harm behavior or substance abuse that would prevent participation in the therapy group, based on clinical judgment
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - 16 weeks
Participants randomized to the Dialectical Behavioural Therapy (DBT) intervention will participate in group-based DBT skills training sessions focusing on emotional control and interpersonal effectiveness.
Weekly 90-minute sessions via Zoom HealthCare or in-person if allowable
Duration - 12 weeks after treatment
Participants complete post-treatment assessments and a 3-month follow-up to evaluate outcomes and intervention acceptability. DBT participants and their parents/guardians will also participate in one-on-one qualitative interviews after the intervention.
Post-treatment and 3-month follow-up assessments with interviews conducted via Zoom or in-person if allowable
Trial Site Locations
Total: 2 locations
1
Clinic Y, Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Actively Recruiting
2
Diabetes Education Resource Centre for Adolescents Clinic, Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A1R9
Actively Recruiting
Research Team
B
Brandy Wicklow, MD MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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