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

May 9, 2018 updated by: Rabin Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach-Tikva, Israel
        • Schneider Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: Every three months
Every three months
adherence to treatment
Time Frame: before the intervention, after the intervention and at the end of the study
before the intervention, after the intervention and at the end of the study
consumption of health services
Time Frame: during the study and at the end of the study
during the study and at the end of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
In the beginning of the study, at the end of the intervention and after 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: Joseph Meyerovitch, MD, Rabin Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2008

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

February 13, 2008

First Submitted That Met QC Criteria

February 13, 2008

First Posted (Estimate)

February 25, 2008

Study Record Updates

Last Update Posted (Actual)

May 15, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • rmc004377ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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