Cognitive Adaptations to Reduce Emotional Stress Associated With Type 1 Diabetes

Not Applicable

Completed

Brief Summary: 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).

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
CARES Intervention- 8 sessions	CARES Intervention	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.
CARES Intervention- 12 sessions	CARES Intervention	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.

Primary Outcome Measures

Name	Time	Method
Problem Areas in Diabetes Survey - Parent Revised (PAID-PR)	absolute value Post-treatment (week 24)	Problem Areas in Diabetes Survey - Parent Revised (PAID-PR); Parents' perceptions of diabetes-related distress, which can encompass fear, sadness, grief, anger, burn-out, and guilt. Higher scores reflect greater perceived distress (range: 0-72)
Center for Epidemiologic Studies - Depression Scale Revised (CESD-R)	absolute value at Post-treatment (week 24)	Center for Epidemiologic Studies - Depression Scale Revised (CESD-R); measure of parental depressive symptoms. Used as a secondary marker of improvement. Higher scores reflect greater occurrence of depressive symptoms (range: 0-60)

Secondary Outcome Measures

Name	Time	Method
Diabetes Family Conflict Scale (DFCS)	absolute value Post-treatment (week 24)	Diabetes Family Conflict Scale (DFCS): parents perceptions of diabetes-related family conflict. Higher scores reflect greater perceived conflict, which includes arguing about daily diabetes tasks and periodic diabetes tasks (range= 19-57)
Hypoglycemia Fear Survey (HFS-P)	absolute value Post-treatment (week 24)	Hypoglycemia Fear Survey (HFS-P); measure of parents fear of hypoglycemia, a secondary symptom that can relate to distress; Higher scores reflect greater perceptions of fear as well as use of hypoglycemia avoidance behaviors (range: 25-125).
Hemoglobin A1c (HbA1c)	absolute value at Post-treatment (week 24)	Proxy measure of glycemic control over the past 12 weeks