Actively Recruiting

Phase Not Applicable
Age: 14Years - 22Years
All Genders
NCT05107154

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

Led by Dr. Brandy Wicklow · Updated on 2024-06-07

60

Participants Needed

2

Research Sites

175 weeks

Total Duration

On this page

Sponsors

D

Dr. Brandy Wicklow

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 14Years - 22Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Youth aged 14 to 22 years with youth-onset Type 2 Diabetes
  • Thirty youths will be recruited for Pilot 1; 15 will receive DBT and 15 will be in a control group
  • An additional 30 youths aged 14 to 22 will be recruited for Pilot 2
  • One caregiver per DBT participant will also participate in Pilot 1
Not Eligible

You will not qualify if you...

  • Diabetes not diagnosed as Type 2, including Type 1, genetic diabetes, cystic fibrosis diabetes, or medication-induced diabetes
  • History of cancer
  • Chronic illnesses causing systemic inflammation (e.g., juvenile rheumatoid arthritis, Crohn's disease)
  • Active psychotic disorder
  • Suicide attempt or active suicide plan within the past year
  • Substance or alcohol use disorder in the past year
  • Unable or unwilling to provide informed assent/consent
  • Currently pregnant (eligible 3 months postpartum)
  • Significant self-harm behavior or substance abuse impairing participation in DBT group based on clinical judgment

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Clinic Y, Health Sciences Centre

Winnipeg, Manitoba, Canada, R3A 1R9

Actively Recruiting

2

Diabetes Education Resource Centre for Adolescents Clinic, Health Sciences Centre

Winnipeg, Manitoba, Canada, R3A1R9

Actively Recruiting

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Research Team

B

Brandy Wicklow, MD MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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