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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00622856
First received: February 13, 2008
Last updated: May 4, 2014
Last verified: May 2014
  Purpose

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 Intervention
Diabetes
Behavioral: psychological intervention
Behavioral: Diabetes education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • HbA1c [ Time Frame: Every three months ] [ Designated as safety issue: No ]
  • adherence to treatment [ Time Frame: befor the intervention, after the intervention and at the end of the study ] [ Designated as safety issue: No ]
  • consumption of health services [ Time Frame: during the study and at the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622856

Contacts
Contact: Yoseph Meyerovitch, MD 03-9253778 josephm@clalit.org.il

Locations
Israel
Schneider Children's Medical Center Recruiting
Petach-Tikva, Israel
Contact: Joseph Meyerovitch, MD    03-9253778    josephm@clalit.org.il   
Principal Investigator: Joseph Meyerovitch, Dr.         
Sub-Investigator: Moshe Phillip, Prof.         
Sub-Investigator: Shlomit Shalitin, Dr.         
Sub-Investigator: Liora Lazar, Dr.         
Sub-Investigator: Liat De Vries, Dr.         
Sub-Investigator: Yael Levental, Dr.         
Sub-Investigator: Rachel Frumkin, Dr.         
Sub-Investigator: Ravital Nimri, Dr.         
Sub-Investigator: Ariel Tenenbaum, Dr.         
Sub-Investigator: Tal Oron, Dr.         
Sub-Investigator: Michal Shinberg         
Sub-Investigator: Maayan Shorer, Dr         
Sub-Investigator: Ravit David         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Joseph Meyerovitch, MD Rabin Medical Center
  More Information

No publications provided by Rabin Medical Center

Additional 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
Study First Received: February 13, 2008
Last Updated: May 4, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
diabetes
adolescents
psychological therapy

ClinicalTrials.gov processed this record on September 18, 2014