N/A
N=37
Cognitive Adaptations to Reduce Emotional Stress Associated With Type 1 Diabetes
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT03698708 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Problem Areas in Diabetes Survey - Parent Revised (PAID-PR) — 32.65; 39.69 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CARES Intervention (Behavioral)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Problem Areas in Diabetes Survey - Parent Revised (PAID-PR) |
32.65; 39.69 | — |
| PRIMARY Center for Epidemiologic Studies - Depression Scale Revised (CESD-R) |
15.85; 12.12 | — |
| SECONDARY Hypoglycemia Fear Survey (HFS-P) |
61.92; 63.56 | — |
| SECONDARY Diabetes Family Conflict Scale (DFCS) |
23.0; 25.62 | — |
| SECONDARY Hemoglobin A1c (HbA1c) |
8.13; 8.45 | — |
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).
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03698708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.