RecruitingNot ApplicableNCT05107154

iCARE 2.0: A Pilot Intervention of Dialectical Behavioural Therapy for Youth With Type 2 Diabetes.


Sponsor

Dr. Brandy Wicklow

Enrollment

60 participants

Start Date

Nov 21, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 14 YearsMax Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study (iCARE 2.0) is testing whether Dialectical Behavior Therapy (DBT) — a structured, skills-based counseling program — helps young people with type 2 diabetes better manage their emotions and improve their diabetes self-care. **You may be eligible if...** - You are between 14 and 22 years old - You have been diagnosed with youth-onset type 2 diabetes **You may NOT be eligible if...** - Your diabetes is type 1, genetic (like MODY), or due to cystic fibrosis or medication use - You have ever been diagnosed with cancer - You have another serious chronic inflammatory disease (e.g., juvenile rheumatoid arthritis, Crohn's disease) - You have an active psychotic disorder such as schizophrenia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALDialectical Behavioural Therapy

DBT skills training is organized into 5 specific modules designed to support skills needed to control emotional reactivity, including: Mindfulness, Distress Tolerance, Walking the Middle Path (a family-based module developed by our co-investigators specifically for teens), Emotion Regulation, and Interpersonal Effectiveness.


Locations(2)

Clinic Y, Health Sciences Centre

Winnipeg, Manitoba, Canada

Diabetes Education Resource Centre for Adolescents Clinic, Health Sciences Centre

Winnipeg, Manitoba, Canada

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NCT05107154


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