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Completed

NCT Number: NCT03698708

Cognitive Adaptations to Reduce Emotional Stress Associated With Type 1 Diabetes

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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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CARES Intervention

Behavioral

A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach.

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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).

  2. 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)

  3. Hemoglobin A1c (HbA1c)

    Time frame: absolute value at Post-treatment (week 24)

    Proxy measure of glycemic control over the past 12 weeks

Other outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Acronym: CARES

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 9, 2018
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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