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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 Type Interventional
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
Enrollment 37
Recruitment Details recruited in clinic, by telephone, and through email
Pre-assignment Details The study recruited parents/caregivers as participants only. Parents gave permission for researchers to collect an HbA1c level for their child. Children did not participate in the treatment.
Arm/Group Title CARES Intervention- 12 Sessions CARES Intervention- 8 Sessions
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 17 20
Completed 13 16
Not Completed 4 4
Arm/Group Title CARES Intervention- 12 Sessions CARES Intervention- 8 Sessions Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 17 20 37
Hide Baseline Analysis Population Description
Primary outcomes were parent report variables: diabetes distress, depressive symptoms, fear of hypoglycemia, treatment satisfaction. As an exploratory variable, we examined children's HbA1c level.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 20 participants 37 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
 100.0%
20
 100.0%
37
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 20 participants 37 participants
41.29  (7.49) 38.25  (6.07) 39.65  (6.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 20 participants 37 participants
Female
16
  94.1%
20
 100.0%
36
  97.3%
Male
1
   5.9%
0
   0.0%
1
   2.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 20 participants 37 participants
Hispanic or Latino
1
   5.9%
1
   5.0%
2
   5.4%
Not Hispanic or Latino
16
  94.1%
19
  95.0%
35
  94.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 20 participants 37 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.9%
1
   5.0%
2
   5.4%
White
15
  88.2%
16
  80.0%
31
  83.8%
More than one race
1
   5.9%
2
  10.0%
3
   8.1%
Unknown or Not Reported
0
   0.0%
1
   5.0%
1
   2.7%
Problem Areas in Diabetes-PR   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 20 participants 37 participants
32.65  (11.87) 39.69  (14.72) 36.45  (13.77)
[1]
Measure Description: This is a validated measure of diabetes distress. Parents/Caregivers completed this measure. Higher scores reflect more distress. Range 0-72.
Center for Epidemiological Study Depression Scale Revised   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 20 participants 37 participants
16.12  (11.21) 11.25  (11.08) 13.49  (10.17)
[1]
Measure Description: This is a measure of depressive symptoms. Parents/Caregivers completed this measure. Higher scores reflect more depressive symptoms. Score range 0-60.
Hypoglycemia Fear Survey-Parents   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 20 participants 37 participants
66.47  (14.12) 67.95  (16.27) 67.27  (15.13)
[1]
Measure Description: This is a measure of hypoglycemia fear. Parents/Caregivers completed this measure. Higher scores reflect greater fear of hypoglycemia. Scores range 25-125.
1.Primary Outcome
Title Problem Areas in Diabetes Survey - Parent Revised (PAID-PR)
Hide Description 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)
Time Frame absolute value Post-treatment (week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
reflects sample of parents who completed the treatment
Arm/Group Title CARES Intervention- 12 Sessions CARES Intervention- 8 Sessions
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 13 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
32.65  (11.87) 39.69  (14.72)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CARES Intervention- 12 Sessions, CARES Intervention- 8 Sessions
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method repeated measures ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter cohen's d
Estimated Value .88
Estimation Comments [Not Specified]
2.Primary Outcome
Title Center for Epidemiologic Studies - Depression Scale Revised (CESD-R)
Hide Description 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)
Time Frame absolute value at Post-treatment (week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
data for parents who completed treatment
Arm/Group Title CARES Intervention- 12 Sessions CARES Intervention- 8 Sessions
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 13 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
15.85  (11.15) 12.12  (9.24)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CARES Intervention- 12 Sessions, CARES Intervention- 8 Sessions
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method repeated measures ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter cohen's d
Estimated Value .22
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Hypoglycemia Fear Survey (HFS-P)
Hide Description 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).
Time Frame absolute value Post-treatment (week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
reflects data from parents who completed treatment
Arm/Group Title CARES Intervention- 12 Sessions CARES Intervention- 8 Sessions
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 13 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
61.92  (12.23) 63.56  (13.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CARES Intervention- 12 Sessions, CARES Intervention- 8 Sessions
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method repeated measures ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter cohen's d
Estimated Value .05
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Diabetes Family Conflict Scale (DFCS)
Hide Description 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)
Time Frame absolute value Post-treatment (week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
reflects data for parents who completed treatment only
Arm/Group Title CARES Intervention- 12 Sessions CARES Intervention- 8 Sessions
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 13 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
23.0  (2.64) 25.62  (7.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CARES Intervention- 12 Sessions, CARES Intervention- 8 Sessions
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method repeated measures ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter cohen's d
Estimated Value .14
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Hemoglobin A1c (HbA1c)
Hide Description Proxy measure of glycemic control over the past 12 weeks
Time Frame absolute value at Post-treatment (week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
reflects data for children of parents who completed treatment only
Arm/Group Title CARES Intervention- 12 Sessions CARES Intervention- 8 Sessions
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 13 16
Mean (Standard Deviation)
Unit of Measure: percentage of glycated hemoglobin cells
8.13  (0.88) 8.45  (1.64)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CARES Intervention- 12 Sessions, CARES Intervention- 8 Sessions
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method repeated measures ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter cohen's d
Estimated Value .09
Estimation Comments [Not Specified]
6.Other Pre-specified Outcome
Title Treatment Satisfaction Survey
Hide Description Treatment Satisfaction Survey; Intervention acceptability and satisfaction. This measure was designed for this pilot study. Higher scores reflect greater satisfaction/acceptability (range: 15-75).
Time Frame absolute value at post-treatment (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CARES Intervention- 12 Sessions CARES Intervention- 8 Sessions
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 13 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
53.93  (5.77) 49.76  (9.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CARES Intervention- 12 Sessions, CARES Intervention- 8 Sessions
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.16
Confidence Interval (2-Sided) 95%
-10.07 to 1.74
Estimation Comments [Not Specified]
Time Frame through study completion, average 7 months
Adverse Event Reporting Description Behavioral trial; deemed less than minimum risk by the IRB of record
 
Arm/Group Title CARES Intervention- 12 Sessions CARES Intervention- 8 Sessions
Hide Arm/Group Description

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.

Children did not receive treatment and were not monitored for adverse events.

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.

Children did not receive treatment and were not monitored for adverse events.

All-Cause Mortality
CARES Intervention- 12 Sessions CARES Intervention- 8 Sessions
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/20 (0.00%) 
Hide Serious Adverse Events
CARES Intervention- 12 Sessions CARES Intervention- 8 Sessions
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CARES Intervention- 12 Sessions CARES Intervention- 8 Sessions
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/20 (0.00%) 
Original proposal called to pilot the CARES in n=12; we recruited additional participants to simultaneously trial the 8-session CARES version. These results are preliminary and require confirmation in a fully powered comparative effectiveness trial.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Susana Patton
Organization: Nemours Children's Health
Phone: 904-697-2000
EMail: susana.patton@nemours.org
Layout table for additonal information
Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03698708    
Other Study ID Numbers: R01DK100779-05 ( U.S. NIH Grant/Contract )
First Submitted: October 3, 2018
First Posted: October 9, 2018
Results First Submitted: December 16, 2021
Results First Posted: February 11, 2022
Last Update Posted: February 11, 2022