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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Petach-Tikva, Israel
- Schneider Children's Medical Center
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 1
Psychological intervention for strengthening parental authority
|
Psychological intervention
|
|
Comparador Ativo: 2
Diabetes education- 5 sessions with diabetes nurse, taking place once a week
|
5 sessions with diabetes nurse
|
|
Sem intervenção: 3
Control group- regular treatment without any intervention
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
HbA1c
Prazo: Every three months
|
Every three months
|
|
adherence to treatment
Prazo: 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
Prazo: during the study and at the end of the study
|
during the study and at the end of the study
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Changes in the wellbeing of adolescents and their parents
Prazo: 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
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- rmc004377ctil
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .