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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

Tracking Information
First Submitted Date  ICMJE October 3, 2018
First Posted Date  ICMJE October 9, 2018
Results First Submitted Date  ICMJE December 16, 2021
Results First Posted Date  ICMJE February 11, 2022
Last Update Posted Date February 11, 2022
Actual Study Start Date  ICMJE January 20, 2019
Actual Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2022)
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
  • Center for Epidemiologic Studies - Depression Scale Revised (CESD-R) [ Time Frame: Change from baseline to Post-treatment (week 24) ]
    Depressive symptoms
  • Problem Areas in Diabetes Survey - Parent Revised (PAID-PR) [ Time Frame: Change from baseline to Post-treatment (week 24) ]
    Diabetes-related distress
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2022)
  • 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).
  • 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)
  • Hemoglobin A1c (HbA1c) [ Time Frame: absolute value at Post-treatment (week 24) ]
    Proxy measure of glycemic control over the past 12 weeks
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
  • Hypoglycemia Fear Survey (HFS-P) [ Time Frame: Change from baseline to Post-treatment (week 24) ]
    Fear of hypoglycemia
  • Diabetes Family Conflict Scale (DFCS) [ Time Frame: Change from baseline to Post-treatment (week 24) ]
    Diabetes-related family conflict
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Change from baseline to Post-treatment (week 24) ]
    Sleep quality
  • Hemoglobin A1c (HbA1c) [ Time Frame: Change from baseline to Post-treatment (week 24) ]
    Proxy measure of glycemic control over the past 12 weeks
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: January 18, 2022)
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).
Original Other Pre-specified Outcome Measures
 (submitted: October 4, 2018)
  • Treatment Satisfaction Survey [ Time Frame: Immediately after intervention ]
    Intervention acceptability and satisfaction
  • 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
 
Descriptive Information
Brief Title  ICMJE Cognitive Adaptations to Reduce Emotional Stress Associated With Type 1 Diabetes
Official Title  ICMJE Longitudinal Test of Adherence & Control in Kids New to Type 1 Diabetes & 5-9 Years Old
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE Behavioral: CARES Intervention
A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: CARES Intervention
  • 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.
    Intervention: Behavioral: CARES Intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2022)
37
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2018)
30
Actual Study Completion Date  ICMJE July 31, 2020
Actual Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03698708
Other Study ID Numbers  ICMJE R01DK100779-05( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Kansas Medical Center
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP