Cognitive Adaptations to Reduce Emotional Stress Associated With Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

— CARES  

Official title:

Longitudinal Test of Adherence & Control in Kids New to Type 1 Diabetes & 5-9 Years Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03698708
• Other study ID #: R01DK100779-05
• Status: Completed
• Phase: N/A
• Start date: January 20, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: January 2022
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• CARES Intervention
A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach.

Locations

Country	Name	City	State
United States	The Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Satisfaction Survey	Treatment Satisfaction Survey; Intervention acceptability and satisfaction. This measure was designed for this pilot study. Higher scores reflect greater satisfaction/acceptability (range: 15-75).	absolute value at post-treatment (week 12)
Primary	Problem Areas in Diabetes Survey - Parent Revised (PAID-PR)	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)	absolute value Post-treatment (week 24)
Primary	Center for Epidemiologic Studies - Depression Scale Revised (CESD-R)	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)	absolute value at Post-treatment (week 24)
Secondary	Hypoglycemia Fear Survey (HFS-P)	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).	absolute value Post-treatment (week 24)
Secondary	Diabetes Family Conflict Scale (DFCS)	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)	absolute value Post-treatment (week 24)
Secondary	Hemoglobin A1c (HbA1c)	Proxy measure of glycemic control over the past 12 weeks	absolute value at Post-treatment (week 24)