The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control
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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 Other: no intervention |
| 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 |
- 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 ]
- 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: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (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
|
|
3
Control group- regular treatment without any intervention
|
Other: no intervention
no 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:
- 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.
- To evaluate the cost as appose to the benefit of the psychological intervention.
- To characterize the different variables in parent's attitude that improve their children's glycemic control.
- 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:
- A treatment group that will go through psychological treatment to strengthen the parents authority.
- A control group that will get an education of a nurse and a dietician
- 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:
- Changes in glycemic control will be measured by levels of HbA1C.
- 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.
- Consumption of health services
- 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 |
Inclusion Criteria:
- Parents of adolescents between the ages of 10-18
- More than one year diabetes
- Adolescent's HbA1c>8
Exclusion Criteria:
- Adolescents or parents of adolescents that are mentally retarded.
- Another chronic disease besides diabetes.
- Adolescents that are taking medications that might disturb their glycemic control.
Contacts and Locations| Contact: Yoseph Meyerovitch, MD | 03-9253778 | josephm@clalit.org.il |
| 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 | |
| Principal Investigator: | Joseph Meyerovitch, MD | Rabin Medical Center |
More Information
No publications provided
| 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: | November 22, 2012 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Rabin Medical Center:
|
diabetes adolescents psychological therapy |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013