Clinical trial NCT00622856: The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control
Official title: The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: diabetes
adolescents
psychological therapy
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2008-02-25
Enrollment: 55
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: HbA1c
timeFrame: Every three months
measure: adherence to treatment
timeFrame: before the intervention, after the intervention and at the end of the study
measure: consumption of health services
timeFrame: during the study and at the end of the study
Secondary outcomes:
measure: Changes in the wellbeing of adolescents and their parents
timeFrame: In the beginning of the study, at the end of the intervention and after 6 months
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: Schneider Children's Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Joseph Meyerovitch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.