NCT05107154

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

Recruiting now NA Last updated 7 June 2024

What this trial tests

NA trial testing Dialectical Behavioural Therapy in Diabetes Mellitus Type 2, Childhood-Onset in 60 participants. Currently enrolling.

Timeline

21 November 2022

Primary endpoint
31 March 2026

31 March 2026

Quick facts

Lead sponsor	Dr. Brandy Wicklow
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	60
Start date	21 November 2022
Primary completion	31 March 2026
Estimated completion	31 March 2026
Sites	2 locations across Canada

Drugs / interventions tested

• Dialectical Behavioural Therapy

Conditions studied

• Diabetes Mellitus Type 2, Childhood-Onset — all drugs for Diabetes Mellitus Type 2, Childhood-Onset →

Sponsor

Dr. Brandy Wicklow

Who can join

Adults 14 to 22, any sex, with Diabetes Mellitus Type 2, Childhood-Onset. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.