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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00622856
• Other study ID #: rmc004377ctil
• Status: Completed
• Phase: N/A
• Start date: February 2008
• Est. completion date: August 2015

Study information

• Verified date: May 2018
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Parents of adolescents between the ages of 10-18

2. More than one year diabetes

3. Adolescent's HbA1c>8

Exclusion Criteria:

1. Adolescents or parents of adolescents that are mentally retarded.

2. Another chronic disease besides diabetes.

3. Adolescents that are taking medications that might disturb their glycemic control.

Related Conditions & MeSH terms

• Diabetes

Intervention

Behavioral:
• psychological intervention
Psychological intervention
• Diabetes education
5 sessions with diabetes nurse

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center	Petach-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		Every three months
Primary	adherence to treatment		before the intervention, after the intervention and at the end of the study
Primary	consumption of health services		during the study and at the end of the study
Secondary	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