Development and Assessment of a Treatment Protocol for Poorly Controlled Diabetic (Type 1) Adolescents, Based on "The New Authority" Model

Sheba Medical Center1 site in 1 country40 target enrollmentJuly 30, 2014

ConditionsType 1 Diabetes

Overview

Phase: N/A
Intervention: Not specified
Conditions: Type 1 Diabetes
Sponsor: Sheba Medical Center
Enrollment: 40
Locations: 1
Primary Endpoint: change in self monitoring of blood glucose
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

It is presumed that families of poorly controlled diabetic adolescents (type 1) would benefit from parents' counselling, guided by "the New Authority" model.

Detailed Description

"The New Authority" model has been shown to be helpful in risk behaviors such as children's violence and school refusal. It is assumed the model would prove helpful in the risk behavior of lack of adherence to diabetes treatment regimen. The treatment is give to parents only, without the adolescent's participation. It is predicted to improve self care, parents' monitoring, family conflict and parents' helplessness.

Registry

clinicaltrials.gov

Start Date

July 30, 2014

End Date

March 30, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sheba Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•diagnosis of diabetes type 1
•condition duration a year or more

Exclusion Criteria

•family does not speak Hebrew
•adolescent doesn't live at home
•serious psychiatric condition in the family

Outcomes

Primary Outcomes

change in self monitoring of blood glucose

Time Frame: assessment at 4 points: enrty, after 3 months, after 6 months and after 9 months

Secondary Outcomes

change in parents' helplessness(assessment at four points: entry, after 3 months, after 6 months and after 9 months)
change in parental monitoring(assessment at four points: entry, after 3 months, after 6 months and after 9 months)
change in reported adherence(assessment at four points: entry, after 3 months, after 6 months and after 9 months)
change in family conflict(assessment at four points: entry, after 3 months, after 6 months and after 9 months)