Communication & Coping Intervention for Diabetes, Autoimmune

Phase-Based Estimates
Vanderbilt University Medical Center, Nashville, TN
Diabetes, Autoimmune+1 More
Communication & Coping Intervention - Behavioral
Any Age
All Sexes
Eligible conditions
Diabetes, Autoimmune

Study Summary

Communication and Coping for Mothers of Adolescents With Type 1 Diabetes

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Eligible Conditions

  • Diabetes, Autoimmune
  • Diabetes Mellitus, Type 1
  • Type 1 Diabetes Mellitus

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Communication & Coping Intervention will improve 1 primary outcome and 15 secondary outcomes in patients with Diabetes, Autoimmune. Measurement will happen over the course of 3 months.

3 months
Adolescent Adherence
Adolescent Diabetes Distress
Adolescent psychosocial functioning - parent report
Adolescent psychosocial functioning - self report
Adolescent quality of life
Diabetes Knowledge
Diabetes-related family conflict - adolescent report
Diabetes-related family conflict - parent report
Glycemic control (A1C)
Maternal Symptoms of Anxiety
Maternal coping
Maternal depressive symptoms
Mothers' Diabetes Distress
Mothers' Social Support
Parental Involvement
6 months
Quality of Parental Involvement

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Education & Check Ins
Communication & Coping Intervention

This trial requires 154 total participants across 2 different treatment groups

This trial involves 2 different treatments. Communication & Coping Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Communication & Coping Intervention
A cognitive behavioral intervention for mothers of adolescents with type 1 diabetes to improve coping and the quality of parental involvement.
Education & Check Ins
The comparison group receives educational materials on diabetes management and phone calls, as well as access to a secret Facebook group with daily posts on diabetes management.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Who is running the study

Principal Investigator
S. J.
Prof. Sarah Jaser, Associate Professor
Vanderbilt University Medical Center

Closest Location

Vanderbilt University Medical Center - Nashville, TN

Eligibility Criteria

This trial is for patients born any sex of any age. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Female caregiver of an adolescent with type 1 diabetes
Adolescent age 11-17
Adolescent diagnosed with type 1 diabetes for at least 12 months
Caregiver reports mild to moderate depressive symptoms (PHQ-9 score of 5-19) OR OR caregiver reports diabetes distress (Parent/Teen Relationship Distress Subscale score of 2 or higher)
English speaking

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is diabetes, autoimmune?

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Diabetes, autoimmune is a disease with insulin resistance and a defect in the ability of beta-cells to respond to glucose. Diabetics fail to produce insulin at blood glucose levels above 11-12 mmol/L. This results in a rise in blood glucose levels leading to the development of many long-term complications that can ultimately cause complications such as blindness, heart disease and kidney failure.\n

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What are the signs of diabetes, autoimmune?

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These three signs should make medical professionals suspect diabetes in individuals who are of Caucasian descent and who have a non-IgA diabetes of unknown cause but whose plasma glucose level is well controlled. Diabetics have a high risk for autoimmune diseases. Diabetes mellitus patients with autoimmune disorders had significantly high rate of [hypothyroidism]( and ankylosing spondylitis compared to matched patients without autoimmune diseases. Insulin should be used cautiously, since it is capable of causing autoimmune thyroiditis and ankylosing spondylitis. The presence of these autoimmune processes indicates that diabetics should use their utmost care in their management and follow a strict diabetic diet.

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What causes diabetes, autoimmune?

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Autoimmunity is an early and important driver of autoimmune diabetes. A combination of immune cell activity against beta cells and autoantibodies to pancreatic islets is the most likely mechanism. Strategies to control autoimmunity may have long-term clinical significance, but initial treatment for people with diabetes may benefit from the prompt identification and treatment of autoimmunity to minimize disease progression and the need for insulin.

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Can diabetes, autoimmune be cured?

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Diabetics with autoimmune disease are much more likely to have remission and control than are those without the condition. Treatment can be challenging, however, because the autoimmune component of some conditions may be difficult to control. With careful monitoring, many diabetics have good control with or without medications and good eye care. Diabetes has to be treated medically to achieve good control and prevent late complications; there is no cure or definitive treatment.

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How many people get diabetes, autoimmune a year in the United States?

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Nearly 7.4 million Americans are diagnosed with [type 1 diabetes]( annually. Diabetes, autoimmune is estimated to cause nearly 825,000 deaths annually in the United States. Diabetes, Autoimmune can be estimated to cause as many as 40,000 strokes every year with at least 10.4 million Americans suffering from the disease.

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What are common treatments for diabetes, autoimmune?

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There is no cure for diabetes or autoimmunity, so treatment of diabetes is focused on symptom management, and is highly dependent on the specific patient. Oral hypoglycemic drugs such as metformin are preferred over injectable treatments, including insulin, because there is less risk of hypoglycemia with oral medication. Autoimmune diseases that affect several areas of the body, such as type 1 diabetes mellitus (T1DM), autoimmune thyroid disease, and rheumatoid arthritis, are more difficult to treat because many patients cannot get access to treatments.

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How does communication & coping intervention work?

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Overall, the results from the current study have indicated that CSW can be a valuable delivery method for this health care programme. There was a significant and large intervention effect found between Group 1 and Group 2, which indicates that CSW in conjunction with a peer-led peer support programme can be effective to help adolescent girls cope with challenges such as rape, body shaming, and experiencing sexual violence.

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What is communication & coping intervention?

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Communication & coping intervention is a new approach to treat patients with Type 2 diabetes and depression who report no improvement in health care use and improvement in patient reports of their diabetes management. In conclusion, communication & coping intervention was effective in both improving patient self-reports and clinic visits in patients with T2D and depressive symptomatology.

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What does communication & coping intervention usually treat?

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Diabetes care providers, particularly those with less experience, tend to underestimate the impact of psychosocial or stress-related factors. Providers, therefore, tend to treat other problems as if they are a result of diabetes complications. Providers also underestimate the contribution of patient beliefs and communication behaviors to well-being. In the absence of communication counseling, and with knowledge that interventions target only one aspect of diabetes management, providers may be inappropriately focused on treatment.

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What is the primary cause of diabetes, autoimmune?

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There has been a steady increase in the number of patients with diabetes since 1997. Diabetes can be secondary to type 1 diabetes or secondary to other causes. There seems to be a link between autoimmune diabetes and thyroid disease. There is also an increased prevalence of diabetes secondary to obesity. Further research in this area is needed to determine if these data are applicable to Caucasians.

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Have there been any new discoveries for treating diabetes, autoimmune?

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Although new drugs, new medical therapies, and devices continue to fall into hand, diabetes remains a challenge to treat because of the need for constant vigilance and adjustments in the treatments and therapy needed to be a successful treatments. If a patient has an autoimmune related disease, especially if the patient has Type 1 diabetes since the 1940s, a blood test will have to show whether or not the patient is diagnosed with diabetes. After diagnosis if the patient has an autoimmune related disease, especially Type 1 diabetes before the 1940s, the patient will have to be monitored to see if the patient needs further treatment from a doctor.

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Have there been other clinical trials involving communication & coping intervention?

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  • COPIS and CAMCOP have similar dropout rates during therapy, but more trials using CAMCOP are underway.\n- A pilot study with 12 participants involved in therapist-controlled group therapy were successful with long-term follow up and demonstrated treatment was not only effective but also inexpensive with low dropout.\n- The use of CAMCOP may be indicated for improving patient wellness, enhancing relationships, decreasing self-identity anxiety, and changing social attitudes and behaviors among individuals with diabetes and poor glycemic control.
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