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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
experimental protocol treatment "The New Authority"
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring diabetes, type 1, adolescents, parents counselling

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sheba Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

parents counseling

Arm Description

parents counseling guided by the experiment protocol

Outcomes

Primary Outcome Measures

change in self monitoring of blood glucose

Secondary Outcome Measures

change in reported adherence
self care inventory questionnaire
change in parents' helplessness
parents' helplessness questionnaire
change in family conflict
diabetes family conflict scale
change in parental monitoring
parental monitoring of diabetes

Full Information

First Posted
February 27, 2014
Last Updated
May 28, 2018
Sponsor
Sheba Medical Center
Collaborators
Juvenile Diabetes Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02093676
Brief Title
Applying the "New Authority" Model in the Treatment of Poorly Controlled Diabetic Adolescents and Their Families
Official Title
Development and Assessment of a Treatment Protocol for Poorly Controlled Diabetic (Type 1) Adolescents, Based on "The New Authority" Model
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 30, 2014 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
Collaborators
Juvenile Diabetes Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
diabetes, type 1, adolescents, parents counselling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
parents counseling
Arm Type
Experimental
Arm Description
parents counseling guided by the experiment protocol
Intervention Type
Behavioral
Intervention Name(s)
experimental protocol treatment "The New Authority"
Other Intervention Name(s)
"The New Authority" model
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
change in reported adherence
Description
self care inventory questionnaire
Time Frame
assessment at four points: entry, after 3 months, after 6 months and after 9 months
Title
change in parents' helplessness
Description
parents' helplessness questionnaire
Time Frame
assessment at four points: entry, after 3 months, after 6 months and after 9 months
Title
change in family conflict
Description
diabetes family conflict scale
Time Frame
assessment at four points: entry, after 3 months, after 6 months and after 9 months
Title
change in parental monitoring
Description
parental monitoring of diabetes
Time Frame
assessment at four points: entry, after 3 months, after 6 months and after 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orit Hamiel, M.D.
Organizational Affiliation
Sheba Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel

12. IPD Sharing Statement

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

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