iCARE 2.0: A Pilot Intervention of Dialectical Behavioural Therapy for Adolescents With Type 2 Diabetes.
Diabetes Mellitus Type 2, Childhood-Onset
About this trial
This is an interventional other trial for Diabetes Mellitus Type 2, Childhood-Onset
Eligibility Criteria
Inclusion Criteria:
- Thirty (30) adolescents (ages 14-17 years old) living with youth onset T2D will be recruited to participate in Pilot 1, fifteen (15) adolescents, and one caregiver, will be randomized to receive DBT and fifteen (15) adolescents will be randomized to a control group.
- An additional thirty adolescents (14-17 years old) will be recruited to participate in Pilot 2.
Exclusion Criteria:
- 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
- Past year suicide attempt or an active plan
- Self-reported substance/alcohol use disorder in past (1 year)
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Dialectical Behavioural Therapy
Control
Participants randomized to the Dialectical Behavioural Therapy (DBT) skills training intervention will receive a 90-minute DBT skills training session every week for 16 weeks total. The sessions will be facilitated by a health practitioner supervised by a clinical health psychologist with expertise in program development and DBT-adaptations for a variety of populations. Sessions for Pilot 1 will be delivered via Zoom HealthCare and in person if allowable. In-person sessions would be delivered at the Children's Hospital Research Institute of Manitoba. Pilot 2 will be adapted to address any additional needs uncovered through he qualitative assessment of Pilot 1. Traditional medicine components will be developed within the first 2 years of the grant by Indigenous researchers, patient and parent advisors, elders, and community advisory groups. These elements will be offered as an encouraged, yet optional component (additional modules) within the 16-week DBT intervention in Pilot 2.
Participants randomized to the control arm will receive standard medical care and clinical follow-up. Controls will be offered DBT after completion of Pilot 1 and 2. Participation will be optional.