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RECRUITING
NCT05107154
NA

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

Sponsor: Dr. Brandy Wicklow

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

14 Years - 22 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2022-11-21

Completion Date

2026-03-31

Last Updated

2024-06-07

Healthy Volunteers

No

Interventions

BEHAVIORAL

Dialectical 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