Diabetes Clinical Trial
Official title:
The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control
A three arms, open, randomized interventional study including 100 participants in order to
evaluate the cost-efficacy of psychological intervention for strengthening parental authority
among parents of diabetic adolescents with poor glycemic control.
All participants will be randomized into three groups:1.The first group will get a
psychological treatment in order to strengthen the parent's authority. 2.The second group
will get an education of a nurse and a dietician. 3.The third group will serve as a control
group and will not go through an intervention.
The following data will be analyzed during the study: 1.Changes in HbA1c. 2.Changes in
parents authority. 3.Changes in the diabetes treatment by the adolescents. 4.Consumption of
health services. 5.The costs of all psychological treatments.
A three arms, open, randomized interventional study including 100 participants in order to
evaluate the cost-efficacy of psychological intervention for strengthening parental authority
among parents of diabetic adolescents with poor glycemic control.
Objectives:
1. The primary purpose of the study is to evaluate the immediate effectiveness and the long
run effectiveness of psychological intervention for strengthening parental authority
among parents of diabetic adolescents with poor glycemic control.
2. To evaluate the cost as appose to the benefit of the psychological intervention.
3. To characterize the different variables in parent's attitude that improve their
children's glycemic control.
4. To develop a therapy model for strengthening parent's authority which will be suitable
for parents of diabetic adolescents.
Study design:
All participants in the study will be randomized to three different groups:
1. A treatment group that will go through psychological treatment to strengthen the parents
authority.
2. A control group that will get an education of a nurse and a dietician
3. A control group that will not get any intervention. All groups will include parents of
diabetic adolescents with poor glycemic control.
The following data will be analyzed during the study:
1. Changes in glycemic control will be measured by levels of HbA1C.
2. Changes in the diabetes treatment by the adolescents will be measured by adherence to
insulin injections, the number of times a day in which the patient checked his blood
glucose values, number of visits in the clinic and psychological questionnaires.
3. Consumption of health services
4. Changes in parents attitude and changes in the wellbeing of the diabetic adolescents and
their parents will be based on questionnaires.
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