Cognitive Adaptations to Reduce Emotional Stress Associated With Type 1 Diabetes

Study Overview
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Brief Summary
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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).

Official Title
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Longitudinal Test of Adherence & Control in Kids New to Type 1 Diabetes & 5-9 Years Old

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: CARES Intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CARES Intervention- 12 sessions<br>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. | Behavioral: CARES Intervention<br>* A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach.<br>|
| Experimental: CARES Intervention- 8 sessions<br>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. | Behavioral: CARES Intervention<br>* A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |