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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Petach-Tikva, Israel
- Schneider Children's Medical Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 1
Psychological intervention for strengthening parental authority
|
Psychological intervention
|
|
Aktiver Komparator: 2
Diabetes education- 5 sessions with diabetes nurse, taking place once a week
|
5 sessions with diabetes nurse
|
|
Kein Eingriff: 3
Control group- regular treatment without any intervention
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
HbA1c
Zeitfenster: Every three months
|
Every three months
|
|
adherence to treatment
Zeitfenster: 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
Zeitfenster: during the study and at the end of the study
|
during the study and at the end of the study
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Changes in the wellbeing of adolescents and their parents
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Joseph Meyerovitch, MD, Rabin Medical Center
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- rmc004377ctil
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