Cognitive Adaptations to Reduce Emotional Stress Associated With Type 1 Diabetes (CARES)

University of Kansas

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Behavioral: CARES Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03698708

R01DK100779-05

Details and patient eligibility

About

The purpose of this study is to evaluate a new intervention (CARES: Cognitive Adaptations to Reduce Emotional Stress Associated with Type 1 Diabetes) designed to reduce caregiver depressive symptoms in families of children with T1D. This is a pilot in which all enrolled parents/caregivers will be placed in the intervention group to assess initial pre- to post-treatment impact of the intervention on parent/caregiver depression, distress, and diabetes-related outcomes (e.g., glycemic control).

Enrollment: 37 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Parent/primary caregiver of a child diagnosed with T1D between 5-12 years old
• Parent/caregiver elevated depression symptoms on the CESD-R (score ≥ 16 at time of screening)
• Child with T1D receiving intensive insulin regimen by multiple dose injections (MDI) or continuous subcutaneous insulin infusion (pump)

Exclusion criteria

• Child with T1D currently in foster care or not living with legal guardian
• Child with evidence of type 2 diabetes or monogenic diabetes
• Child with a co-morbid chronic illness (e.g., renal disease) that requires ongoing care beyond T1D
• Children who are chronically using medications that may impact glycemic control (i.e., systemic steroids)
• Parents/caregivers who do not speak English (currently there is no way to recruit non-English speaking families because the study questionnaires are only available in English)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

CARES Intervention- 12 sessions

Experimental group

Description:

Participants in the intervention will participate in 12 weekly group-based telemedicine intervention sessions (up to 60 minutes each) with other parents/caregivers of children with T1D. Intervention sessions focus on cognitive-behavioral therapy to treat depression, including identifying cognitive distortions, cognitive restructuring, behavioral activation, coping strategies, and learning diabetes management skills.

Treatment:

Behavioral: CARES Intervention

CARES Intervention- 8 sessions

Experimental group

Description:

Participants in the intervention will participate in 8 weekly group-based telemedicine intervention sessions (up to 60 minutes each) with other parents/caregivers of children with T1D. Intervention sessions focus on cognitive-behavioral therapy to treat depression, including identifying cognitive distortions, cognitive restructuring, behavioral activation, coping strategies, and learning diabetes management skills.

Treatment:

Behavioral: CARES Intervention