The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control
Condition: Diabetes
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): psychological intervention; Diabetes education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Psychological intervention; 5 sessions with diabetes nurse
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; adolescents; psychological therapy