Type 1 Diabetes Study for Teens
What is the purpose of this study?
Cincinnati Children’s Hospital Medical Center is conducting a family-based research study, sometimes known as a clinical trial or clinical study, to see how group meetings with an expert help families to improve their communication, and teenagers to cope better with their emotions and stick to their diabetes treatment.
Who will be included in this study?
Families (may be one parent, both parents or a legal caregiver) with a teenager between the ages of 13 and 17 years old who:
- Has been diagnosed with Type 1 Diabetes for at least one year
- Has symptoms of depression (will be confirmed through a questionnaire)
What is involved?
The study will last for approximately 6 months and includes 1 screening visit and 13 study visits. If your child qualifies for this study after the initial screening, you and your child will be randomized (put into one of two study groups by chance). The main difference between the groups is in the timing of the intervention sessions. The study includes the following:
- 10 intervention sessions which involve meetings with teen groups, parent groups and teens and parents together. The goals are to help teenagers recognize their emotions and learn new ways to respond, and for parents to better understand teen depression, the link between how their family functions and diabetes management, and to learn how to better communicate with their teens. Teens and parents will also identify barriers and priorities to better diabetes management, and develop specific plans for home.
- 4 assessments which involve completion of questionnaires and interviews. The questions are about your and your child’s feelings about his/her diabetes and about how it is managed in your family.
- One blood sample from your child to obtain his/her hemoglobin A1c value
- Download of your child’s meter
What are the benefits?
Although there are potential benefits from participating in this research study, you and your child may not receive a medical benefit. Potential benefits may be that your child feels less depressed, your family functions better, and you and your child manage his/her diabetes better.
Will I get all the facts about the study?
You will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent or guardian has signed this form and, if of age, the child has given at minimum, his/her verbal agreement.
What are the risks and discomforts of the study?
You or your child may feel uncomfortable answering some of the questions on the questionnaires and/or in the interviews. Your child may feel some discomfort from giving the blood sample, although it is similar to his/her finger-sticks to check blood sugars. A detailed list of risks and discomforts will be provided to those interested in knowing more about this study.
What is the pay?
Families will receive up to $220 for their time and effort.
Who should I contact for more information?
Tony Vesco
513-803-0766
Anthony.vesco@cchmc.org
Or
Natoshia Cunningham
513-803-2745
Natoshia.cunningham@cchmc.org
Adherence Psychology
Cincinnati Children’s Hospital Medical Center
Principal Investigator:
Korey K. Hood, PhD
Adherence Psychology
Cincinnati Children’s Hospital Medical Center
