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

• 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: University of Kansas Medical Center
• Information provided by (Responsible Party): University of Kansas Medical Center

Tracking Information

• First Submitted Date: October 3, 2018
• First Posted Date: October 9, 2018
• Results First Submitted Date: December 16, 2021
• Results First Posted Date: February 11, 2022
• Last Update Posted Date: February 11, 2022
• Actual Study Start Date: January 20, 2019
• Actual Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: Cognitive Adaptations to Reduce Emotional Stress Associated With Type 1 Diabetes
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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.

Study Arms

• 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 *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 18, 2022): 37
• Original Estimated Enrollment (submitted: October 4, 2018): 30
• Actual Study Completion Date: July 31, 2020
• Actual Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 5 Years to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03698708
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Current Responsible Party: University of Kansas Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Kansas Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Kansas Medical Center
• Verification Date: January 2022