The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control

Study Overview
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Brief Summary
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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
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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: 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. To evaluate the cost as appose to the benefit of the psychological intervention. To characterize the different variables in parent's attitude that improve their children's glycemic control. 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: A treatment group that will go through psychological treatment to strengthen the parents authority. A control group that will get an education of a nurse and a dietician 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: Changes in glycemic control will be measured by levels of HbA1C. 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. Consumption of health services Changes in parents attitude and changes in the wellbeing of the diabetic adolescents and their parents will be based on questionnaires.

Official Title
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The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: psychological intervention
* Behavioral: Diabetes education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents of adolescents between the ages of 10-18 More than one year diabetes Adolescent's HbA1c>8 Exclusion Criteria: Adolescents or parents of adolescents that are mentally retarded. Another chronic disease besides diabetes. Adolescents that are taking medications that might disturb their glycemic control.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Psychological intervention for strengthening parental authority | Behavioral: psychological intervention<br>* Psychological intervention<br>|
| Active Comparator: 2<br>Diabetes education- 5 sessions with diabetes nurse, taking place once a week | Behavioral: Diabetes education<br>* 5 sessions with diabetes nurse<br>|
| No Intervention: 3<br>Control group- regular treatment without any intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | Every three months | 
| adherence to treatment |  | before the intervention, after the intervention and at the end of the study | 
| consumption of health services |  | during the study and at the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the wellbeing of adolescents and their parents |  | In the beginning of the study, at the end of the intervention and after 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, adolescents, psychological therapy