The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control
NCT ID: NCT00622856
Last Updated: 2018-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2008-02-29
2015-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Psychological intervention for strengthening parental authority
psychological intervention
Psychological intervention
2
Diabetes education- 5 sessions with diabetes nurse, taking place once a week
Diabetes education
5 sessions with diabetes nurse
3
Control group- regular treatment without any intervention
No interventions assigned to this group
Interventions
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psychological intervention
Psychological intervention
Diabetes education
5 sessions with diabetes nurse
Eligibility Criteria
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Inclusion Criteria
2. More than one year diabetes
3. Adolescent's HbA1c\>8
Exclusion Criteria
2. Another chronic disease besides diabetes.
3. Adolescents that are taking medications that might disturb their glycemic control.
10 Years
18 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Principal Investigators
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Joseph Meyerovitch, MD
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center
Locations
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Schneider Children's Medical Center
Petah Tikva, , Israel
Countries
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References
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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.
Other Identifiers
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rmc004377ctil
Identifier Type: -
Identifier Source: org_study_id
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