Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-03 @ 9:02 PM
Study NCT ID:
NCT00622856
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
2008-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control
Sponsor:
Rabin Medical Center
Organization:
Study Overview
Official Title:
The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: