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Cognitive Adaptations to Reduce Emotional Stress Associated With Type 1 Diabetes (CARES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03698708
Recruitment Status : Completed
First Posted : October 9, 2018
Results First Posted : February 11, 2022
Last Update Posted : February 11, 2022
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Behavioral: CARES Intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Longitudinal Test of Adherence & Control in Kids New to Type 1 Diabetes & 5-9 Years Old
Actual Study Start Date : January 20, 2019
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Behavioral: CARES Intervention
A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach.
Experimental: 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.
 Behavioral: CARES Intervention
A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach.


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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 Outcome Measures :
  1. Hypoglycemia Fear Survey (HFS-P) [ Time Frame: absolute value Post-treatment (week 24) ]
    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).

  2. Diabetes Family Conflict Scale (DFCS) [ Time Frame: absolute value Post-treatment (week 24) ]
    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)

  3. Hemoglobin A1c (HbA1c) [ Time Frame: absolute value at Post-treatment (week 24) ]
    Proxy measure of glycemic control over the past 12 weeks


Other Outcome Measures:
  1. Treatment Satisfaction Survey [ Time Frame: absolute value at post-treatment (week 12) ]
    Treatment Satisfaction Survey; Intervention acceptability and satisfaction. This measure was designed for this pilot study. Higher scores reflect greater satisfaction/acceptability (range: 15-75).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03698708


Locations
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United States, Missouri
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
University of Kansas Medical Center
  Study Documents (Full-Text)

Documents provided by University of Kansas Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] October 4, 2021

More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03698708    
Other Study ID Numbers: R01DK100779-05 ( U.S. NIH Grant/Contract )
First Posted: October 9, 2018    Key Record Dates
Results First Posted: February 11, 2022
Last Update Posted: February 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases