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

Clalit Health Services

Status: Completed

Conditions: Diabetes

Treatments: Behavioral: Diabetes education; Behavioral: psychological intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00622856

rmc004377ctil

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 3 patient groups

1

Experimental group

Description:

Psychological intervention for strengthening parental authority

Treatment:

Behavioral: psychological intervention

2

Active Comparator group

Description:

Diabetes education- 5 sessions with diabetes nurse, taking place once a week

Treatment:

Behavioral: Diabetes education

3

No Intervention group

Description:

Control group- regular treatment without any intervention