Dialectical Behavioural Therapy for Indigenous Youth with Type 2 Diabetes
iCARE 2.0: A Pilot Intervention of Dialectical Behavioural Therapy for Youth With Type 2 Diabetes.
This study is testing a new program that combines Dialectical Behavioural Therapy and traditional Indigenous medicine to see if it can help First Nations youth with Type 2 Diabetes manage their health better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 14 Years to 22 Years |
| Sex | All |
| Sponsor | University of Manitoba Academic / other |
| Locations | 2 sites (Winnipeg, Manitoba and 1 other locations) |
| Trial ID | NCT05107154 on ClinicalTrials.gov |
What this trial studies
This pilot intervention aims to address health disparities faced by First Nations children with Type 2 Diabetes by implementing a co-developed program that includes Dialectical Behavioural Therapy (DBT). The study will involve a quasi-experimental design with adolescents and their caregivers participating in group-based DBT or a control group. Data will be collected through pre- and post-measures, as well as qualitative interviews after the intervention. The program also seeks to incorporate traditional Indigenous medicine practices to enhance its relevance and effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are Indigenous adolescents aged 14-22 years living with childhood-onset Type 2 Diabetes.
Not a fit: Patients with diabetes types other than Type 2, active psychotic disorders, or significant substance use issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve mental health and diabetes management in Indigenous youth, potentially reducing the risk of complications such as kidney disease.
How similar studies have performed: While there is limited research specifically on this approach, similar interventions using DBT have shown promise in improving mental health outcomes in various populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Thirty (30) youths (ages 14-22 years old) living with youth onset T2D will be recruited to participate in Pilot 1, fifteen (15) youths, and one caregiver, will be randomized to receive DBT and fifteen (15) adolescents will be randomized to a control group. * An additional thirty youths (14-22 years old) will be recruited to participate in Pilot 2. Exclusion Criteria: * Diabetes not diagnosed as type 2 diabetes including: type 1 diabetes, genetic diabetes, cystic fibrosis diabetes, diabetes secondary to medication use. * Ever cancer * Other chronic illness associated with systemic inflammation (ex. Juvenile rheumatoid arthritis, Crohn's disease) * Active psychotic disorder * Past year suicide attempt or an active plan * Self-reported substance/alcohol use disorder in past (1 year) * Patient and/or caregiver unable or unwilling to provide voluntary informed assent/consent * Currently pregnant (eligible at 3 months post-partum) * Exclusion criteria would include significant self-harm behaviour and substance abuse, which would impair affective participation in a DBT group setting based on clinical judgement.
Where this trial is running
Winnipeg, Manitoba and 1 other locations
- Clinic Y, Health Sciences Centre — Winnipeg, Manitoba, Canada (Recruiting)
- Diabetes Education Resource Centre for Adolescents Clinic, Health Sciences Centre — Winnipeg, Manitoba, Canada (Recruiting)
Study contacts
- Principal investigator: Brandy Wicklow, MD MSc — University of Manitoba
- Study coordinator: Brandy Wicklow, MD MSc
- Email: bwicklow@hsc.mb.ca
- Phone: 2047871222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.