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

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ClinicalTrials.gov Identifier: NCT00622856
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

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.


Condition or disease Intervention/treatment Phase
Diabetes Behavioral: psychological intervention Behavioral: Diabetes education Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control
Actual Study Start Date : February 2008
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: 1
Psychological intervention for strengthening parental authority
Behavioral: psychological intervention
Psychological intervention

Active Comparator: 2
Diabetes education- 5 sessions with diabetes nurse, taking place once a week
Behavioral: Diabetes education
5 sessions with diabetes nurse

No Intervention: 3
Control group- regular treatment without any intervention



Primary Outcome Measures :
  1. HbA1c [ Time Frame: Every three months ]
  2. adherence to treatment [ Time Frame: before the intervention, after the intervention and at the end of the study ]
  3. consumption of health services [ Time Frame: during the study and at the end of the study ]

Secondary Outcome Measures :
  1. Changes in the wellbeing of adolescents and their parents [ Time Frame: In the beginning of the study, at the end of the intervention and after 6 months ]


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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622856


Locations
Israel
Schneider Children's Medical Center
Petach-Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Joseph Meyerovitch, MD Rabin Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00622856     History of Changes
Other Study ID Numbers: rmc004377ctil
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Keywords provided by Rabin Medical Center:
diabetes
adolescents
psychological therapy