NCT05107154Completed
iCARE 2.0: A Pilot Intervention of Dialectical Behavioural Therapy for Youth With Type 2 Diabetes.
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
In partnership with youth, parents, and community members the investigators have co-developed a program of research designed to address the substantial health disparities faced by First Nations children and families, and the calls to action from the Truth and Reconciliation Report. Specifically; the investigators aim to address the high rates of kidney disease in Indigenous children living with Type 2 Diabetes (T2D), by identifying and understanding the root causes for progression of kidney disease and working together to build an evidenced based, novel therapy for diabetes that focuses on mindfulness, personal strengths and incorporates traditional medicine practices that are meaningful to patients. The investigators have planned 2 pilots in order to address the uncertainties surrounding the planning of a larger definitive trial and allow adequate engagement and building of a meaningful traditional medicine component. These pilots will inform the development of a co-designed, feasible, and embraced Dialectical Behavioural Therapy (DBT) skills training and traditional teachings intervention, which is adequately powered to examine effectiveness on outcomes such as mental wellness, medication adherence, and improved glycemic control and renal function. Research Aims: 1. Determine the recruitment, enrollment and adherence rates to the intervention. 2. Evaluate acceptability of the intervention using traditional qualitative methods and Indigenous world view methodology 3. Determine the estimated effect size required to power a large-scale DBT randomized control trial for the outcomes quality of life (primary), glycemic control and albuminuria (secondary). Study Hypotheses: 1. The investigators hypothesize that a DBT intervention will be feasible on a local and National Platform and will be acceptable and embraced by youth with T2D as an important component of their management plan. 2. The investigators hypothesize that the additional of traditional medicine elements will increase the acceptability and adherence to DBT for Indigenous children.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 19 Oct 2021
- Start date
- 21 Nov 2022
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Dr. Brandy Wicklow
- Diseases
- Type 2 diabetes
- NCT number
- NCT05107154
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 21 Nov 2022 to the primary completion date, 1 Jun 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Self-reported substance/alcohol use disorder in past (1 year)
Other
- Past year suicide attempt or an active plan
- 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.
Who the study is looking for
- 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.
Age in the registry: 14 years to 22 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinic Y, Health Sciences Centre Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Diabetes Education Resource Centre for Adolescents Clinic, Health Sciences Centre Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.