Clinical trial NCT03698708: Cognitive Adaptations to Reduce Emotional Stress Associated With Type 1 Diabetes
Official title: Longitudinal Test of Adherence & Control in Kids New to Type 1 Diabetes & 5-9 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 37
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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)

Primary outcomes:
measure: Problem Areas in Diabetes Survey - Parent Revised (PAID-PR)
timeFrame: absolute value Post-treatment (week 24)
measure: Center for Epidemiologic Studies - Depression Scale Revised (CESD-R)
timeFrame: absolute value at Post-treatment (week 24)
Secondary outcomes:
measure: Hypoglycemia Fear Survey (HFS-P)
timeFrame: absolute value Post-treatment (week 24)
measure: Diabetes Family Conflict Scale (DFCS)
timeFrame: absolute value Post-treatment (week 24)
measure: Hemoglobin A1c (HbA1c)
timeFrame: absolute value at Post-treatment (week 24)
Other outcomes:
measure: Treatment Satisfaction Survey
timeFrame: absolute value at post-treatment (week 12)
Locations:
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Missouri
Study officials:
References:
citation: Case H, Williams DD, Majidi S, Ferro D, Clements MA, Patton SR. Longitudinal associations between family conflict, parent engagement, and metabolic control in children with recent-onset type 1 diabetes. BMJ Open Diabetes Res Care. 2021 Oct;9(1):e002461. doi: 10.1136/bmjdrc-2021-002461.
citation: McConville A, Noser AE, Nelson EL, Clements MA, Majidi S, Patton SR. Depression as a predictor of hypoglycemia worry in parents of youth with recent-onset type 1 diabetes. Pediatr Diabetes. 2020 Aug;21(5):909-916. doi: 10.1111/pedi.13039. Epub 2020 May 29.