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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CARES Intervention- 12 sessions | Experimental | 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- 8 sessions | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CARES Intervention | Behavioral | A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | absolute value Post-treatment (week 24) |
| 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) | absolute value at Post-treatment (week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | absolute value Post-treatment (week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | absolute value at post-treatment (week 12) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34645616 | Derived | 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. | |
| 32410305 | Derived | 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. |
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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.
recruited in clinic, by telephone, and through email
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | reflects sample of parents who completed the treatment | Posted | Mean | Standard Deviation | units on a scale | absolute value Post-treatment (week 24) |
|
through study completion, average 7 months
Behavioral trial; deemed less than minimum risk by the IRB of record
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Children did not receive treatment and were not monitored for adverse events. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susana Patton | Nemours Children's Health | 904-697-2000 | susana.patton@nemours.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2021 | Jan 16, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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) |
| absolute value Post-treatment (week 24) |
| Hemoglobin A1c (HbA1c) | Proxy measure of glycemic control over the past 12 weeks | absolute value at Post-treatment (week 24) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Problem Areas in Diabetes-PR | This is a validated measure of diabetes distress. Parents/Caregivers completed this measure. Higher scores reflect more distress. Range 0-72. | Mean | Standard Deviation | units on a scale |
|
| Center for Epidemiological Study Depression Scale Revised | This is a measure of depressive symptoms. Parents/Caregivers completed this measure. Higher scores reflect more depressive symptoms. Score range 0-60. | Mean | Standard Deviation | units on a scale |
|
| Hypoglycemia Fear Survey-Parents | This is a measure of hypoglycemia fear. Parents/Caregivers completed this measure. Higher scores reflect greater fear of hypoglycemia. Scores range 25-125. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
|
| 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) | data for parents who completed treatment | Posted | Mean | Standard Deviation | units on a scale | absolute value at Post-treatment (week 24) |
|
|
|
|
| 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). | reflects data from parents who completed treatment | Posted | Mean | Standard Deviation | units on a scale | absolute value Post-treatment (week 24) |
|
|
|
|
| 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) | reflects data for parents who completed treatment only | Posted | Mean | Standard Deviation | units on a scale | absolute value Post-treatment (week 24) |
|
|
|
|
| Secondary | Hemoglobin A1c (HbA1c) | Proxy measure of glycemic control over the past 12 weeks | reflects data for children of parents who completed treatment only | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin cells | absolute value at Post-treatment (week 24) |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | absolute value at post-treatment (week 12) |
|
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | 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. Children did not receive treatment and were not monitored for adverse events. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |