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

February 13, 2008
May 4, 2014
February 2008
December 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00622856 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control
The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes
  • Behavioral: psychological intervention
    Psychological intervention
  • Behavioral: Diabetes education
    5 sessions with diabetes nurse
  • Experimental: 1
    Psychological intervention for strengthening parental authority
    Intervention: Behavioral: psychological intervention
  • Active Comparator: 2
    Diabetes education- 5 sessions with diabetes nurse, taking place once a week
    Intervention: Behavioral: Diabetes education
  • No Intervention: 3
    Control group- regular treatment without any intervention
Yackobovitch-Gavan M, Meshy-Tamir R, Nagelberg N, Phillip M, Meyerovitch J. Psychosocial factors associated with depressive mood in Israeli obese adolescents. J Health Psychol. 2014 Apr;19(4):574-84. doi: 10.1177/1359105313475901. Epub 2013 Mar 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
10 Years to 18 Years
No
Contact: Yoseph Meyerovitch, MD 03-9253778 josephm@clalit.org.il
Israel
 
NCT00622856
rmc004377ctil
No
Rabin Medical Center
Rabin Medical Center
Not Provided
Principal Investigator: Joseph Meyerovitch, MD Rabin Medical Center
Rabin Medical Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP