Applying the "New Authority" Model in the Treatment of Poorly Controlled Diabetic Adolescents and Their Families

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093676
• Other study ID #: SHEBA-13-0770-YRK-CTIL
• Status: Completed
• Phase: N/A
• Start date: July 30, 2014
• Est. completion date: March 30, 2018

Study information

• Verified date: May 2018
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• experimental protocol treatment "The New Authority"

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in self monitoring of blood glucose		assessment at 4 points: enrty, after 3 months, after 6 months and after 9 months
Secondary	change in reported adherence	self care inventory questionnaire	assessment at four points: entry, after 3 months, after 6 months and after 9 months
Secondary	change in parents' helplessness	parents' helplessness questionnaire	assessment at four points: entry, after 3 months, after 6 months and after 9 months
Secondary	change in family conflict	diabetes family conflict scale	assessment at four points: entry, after 3 months, after 6 months and after 9 months
Secondary	change in parental monitoring	parental monitoring of diabetes	assessment at four points: entry, after 3 months, after 6 months and after 9 months