Cognitive Adaptations to Reduce Emotional Stress Associated With Type 1 Diabetes
NCT ID: NCT03698708
Last Updated: 2022-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2019-01-20
2020-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CARES Intervention- 12 sessions
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.
CARES Intervention
A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach.
CARES Intervention- 8 sessions
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
A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach.
Interventions
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CARES Intervention
A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach.
Eligibility Criteria
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Inclusion Criteria
* 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 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)
5 Years
12 Years
ALL
No
Sponsors
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University of Kansas Medical Center
OTHER
Responsible Party
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Locations
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The Children's Mercy Hospital
Kansas City, Missouri, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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