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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Petach-Tikva, Israel
- Schneider Children's Medical Center
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 1
Psychological intervention for strengthening parental authority
|
Psychological intervention
|
|
Comparador activo: 2
Diabetes education- 5 sessions with diabetes nurse, taking place once a week
|
5 sessions with diabetes nurse
|
|
Sin intervención: 3
Control group- regular treatment without any intervention
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
HbA1c
Periodo de tiempo: Every three months
|
Every three months
|
|
adherence to treatment
Periodo de tiempo: before the intervention, after the intervention and at the end of the study
|
before the intervention, after the intervention and at the end of the study
|
|
consumption of health services
Periodo de tiempo: during the study and at the end of the study
|
during the study and at the end of the study
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Changes in the wellbeing of adolescents and their parents
Periodo de tiempo: In the beginning of the study, at the end of the intervention and after 6 months
|
In the beginning of the study, at the end of the intervention and after 6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Joseph Meyerovitch, MD, Rabin Medical Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- rmc004377ctil
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