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

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: experimental protocol treatment "The New Authority"

• Registration Number: NCT02093676
• Lead Sponsor: Sheba Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-02-27
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-21
• Study Start: 2014-07-30
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-28
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
parents counseling	experimental protocol treatment "The New Authority"	parents counseling guided by the experiment protocol

Primary Outcome Measures

Name	Time	Method
change in self monitoring of blood glucose	assessment at 4 points: enrty, after 3 months, after 6 months and after 9 months

Secondary Outcome Measures

Name	Time	Method
change in parental monitoring	assessment at four points: entry, after 3 months, after 6 months and after 9 months	parental monitoring of diabetes
change in parents' helplessness	assessment at four points: entry, after 3 months, after 6 months and after 9 months	parents' helplessness questionnaire
change in reported adherence	assessment at four points: entry, after 3 months, after 6 months and after 9 months	self care inventory questionnaire
change in family conflict	assessment at four points: entry, after 3 months, after 6 months and after 9 months	diabetes family conflict scale

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel