Longitudinal Test of Adherence & Control in Kids New to Type 1 Diabetes & 5-9 Years Old
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Problem Areas in Diabetes Survey - Parent Revised (PAID-PR)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Problem Areas in Diabetes Survey - Parent Revised (PAID-PR)
Time Frame: 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)
Time Frame: 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 Outcomes
- Diabetes Family Conflict Scale (DFCS)(absolute value Post-treatment (week 24))
- Hypoglycemia Fear Survey (HFS-P)(absolute value Post-treatment (week 24))
- Hemoglobin A1c (HbA1c)(absolute value at Post-treatment (week 24))