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

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ClinicalTrials.gov Identifier: NCT03698708
Recruitment Status : Recruiting
First Posted : October 8, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

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, single-arm study, 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group 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
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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




Primary Outcome Measures :
  1. Center for Epidemiologic Studies - Depression Scale Revised (CESD-R) [ Time Frame: Change from baseline to Post-treatment (week 24) ]
    Depressive symptoms

  2. Problem Areas in Diabetes Survey - Parent Revised (PAID-PR) [ Time Frame: Change from baseline to Post-treatment (week 24) ]
    Diabetes-related distress


Secondary Outcome Measures :
  1. Hypoglycemia Fear Survey (HFS-P) [ Time Frame: Change from baseline to Post-treatment (week 24) ]
    Fear of hypoglycemia

  2. Diabetes Family Conflict Scale (DFCS) [ Time Frame: Change from baseline to Post-treatment (week 24) ]
    Diabetes-related family conflict

  3. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Change from baseline to Post-treatment (week 24) ]
    Sleep quality

  4. Hemoglobin A1c (HbA1c) [ Time Frame: Change from baseline to Post-treatment (week 24) ]
    Proxy measure of glycemic control over the past 12 weeks

  5. Frequency of blood glucose self-monitoring, mean daily blood glucose, percent high BG, percent low BG, BOLUS behavior [ Time Frame: Collected every 2-4 weeks baseline to Post-treatment (week 24) ]
    14-day glucometer uploads


Other Outcome Measures:
  1. Treatment Satisfaction Survey [ Time Frame: Immediately after intervention ]
    Intervention acceptability and satisfaction

  2. Qualitative Interview [ Time Frame: Immediately after intervention ]
    Focus group to identify areas of the intervention that were most helpful, barriers to intervention effectiveness, and ways to improve the intervention for the future



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)

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


Contacts
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Contact: Susana R Patton, PhD, CDE 913-588-6323 spatton2@kumc.edu

Locations
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United States, Missouri
The Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Mark Clements    816-234-3000    maclements@cmh.edu   
Principal Investigator: Mark Clements, MD         
Principal Investigator: Kathy Goggin, PhD         
Sponsors and Collaborators
University of Kansas Medical Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03698708     History of Changes
Other Study ID Numbers: R01DK100779-05 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
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