Type 1 Diabetes Mellitus
Conditions
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).
Interventions
BEHAVIORALCARES Intervention
A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach.
Sponsors
University of Kansas Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Problem Areas in Diabetes Survey - Parent Revised (PAID-PR) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia Fear Survey (HFS-P) | 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) | 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) | absolute value at Post-treatment (week 24) | Proxy measure of glycemic control over the past 12 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction Survey | 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). |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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.
CARES Intervention: A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach. | 17 |
| 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.
CARES Intervention: A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach. | 20 |
| Total | 37 |
Baseline characteristics
| Characteristic | CARES Intervention- 12 Sessions | CARES Intervention- 8 Sessions | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 20 Participants | 37 Participants |
| Age, Continuous | 41.29 years STANDARD_DEVIATION 7.49 | 38.25 years STANDARD_DEVIATION 6.07 | 39.65 years STANDARD_DEVIATION 6.84 |
| Center for Epidemiological Study Depression Scale Revised | 16.12 units on a scale STANDARD_DEVIATION 11.21 | 11.25 units on a scale STANDARD_DEVIATION 11.08 | 13.49 units on a scale STANDARD_DEVIATION 10.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 19 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hypoglycemia Fear Survey-Parents | 66.47 units on a scale STANDARD_DEVIATION 14.12 | 67.95 units on a scale STANDARD_DEVIATION 16.27 | 67.27 units on a scale STANDARD_DEVIATION 15.13 |
| Problem Areas in Diabetes-PR | 32.65 units on a scale STANDARD_DEVIATION 11.87 | 39.69 units on a scale STANDARD_DEVIATION 14.72 | 36.45 units on a scale STANDARD_DEVIATION 13.77 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Female | 16 Participants | 20 Participants | 36 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 20 |
| other Total, other adverse events | 0 / 17 | 0 / 20 |
| serious Total, serious adverse events | 0 / 17 | 0 / 20 |
Outcome results
Primary
Center for Epidemiologic Studies - Depression Scale Revised (CESD-R)
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)
Population: data for parents who completed treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CARES Intervention- 12 Sessions | Center for Epidemiologic Studies - Depression Scale Revised (CESD-R) | 15.85 units on a scale | Standard Deviation 11.15 |
| CARES Intervention- 8 Sessions | Center for Epidemiologic Studies - Depression Scale Revised (CESD-R) | 12.12 units on a scale | Standard Deviation 9.24 |
repeated measures ANOVA
Primary
Problem Areas in Diabetes Survey - Parent Revised (PAID-PR)
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)
Population: reflects sample of parents who completed the treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CARES Intervention- 12 Sessions | Problem Areas in Diabetes Survey - Parent Revised (PAID-PR) | 32.65 units on a scale | Standard Deviation 11.87 |
| CARES Intervention- 8 Sessions | Problem Areas in Diabetes Survey - Parent Revised (PAID-PR) | 39.69 units on a scale | Standard Deviation 14.72 |
repeated measures ANOVA
Secondary
Diabetes Family Conflict Scale (DFCS)
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)
Population: reflects data for parents who completed treatment only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CARES Intervention- 12 Sessions | Diabetes Family Conflict Scale (DFCS) | 23.0 units on a scale | Standard Deviation 2.64 |
| CARES Intervention- 8 Sessions | Diabetes Family Conflict Scale (DFCS) | 25.62 units on a scale | Standard Deviation 7.34 |
repeated measures ANOVA
Secondary
Hemoglobin A1c (HbA1c)
Proxy measure of glycemic control over the past 12 weeks
Time frame: absolute value at Post-treatment (week 24)
Population: reflects data for children of parents who completed treatment only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CARES Intervention- 12 Sessions | Hemoglobin A1c (HbA1c) | 8.13 percentage of glycated hemoglobin cells | Standard Deviation 0.88 |
| CARES Intervention- 8 Sessions | Hemoglobin A1c (HbA1c) | 8.45 percentage of glycated hemoglobin cells | Standard Deviation 1.64 |
repeated measures ANOVA
Secondary
Hypoglycemia Fear Survey (HFS-P)
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)
Population: reflects data from parents who completed treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CARES Intervention- 12 Sessions | Hypoglycemia Fear Survey (HFS-P) | 61.92 units on a scale | Standard Deviation 12.23 |
| CARES Intervention- 8 Sessions | Hypoglycemia Fear Survey (HFS-P) | 63.56 units on a scale | Standard Deviation 13.36 |
repeated measures ANOVA
Other Pre-specified
Treatment Satisfaction Survey
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CARES Intervention- 12 Sessions | Treatment Satisfaction Survey | 53.93 score on a scale | Standard Deviation 5.77 |
| CARES Intervention- 8 Sessions | Treatment Satisfaction Survey | 49.76 score on a scale | Standard Deviation 9.44 |
95% CI: [-10.07, 1.74]ANOVA