Trials / Completed
CompletedNCT00622856
The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Rabin Medical Center · Academic / Other
- Sex
- All
- Age
- 10 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | psychological intervention | Psychological intervention |
| BEHAVIORAL | Diabetes education | 5 sessions with diabetes nurse |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2008-02-25
- Last updated
- 2018-05-15
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT00622856. Inclusion in this directory is not an endorsement.