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

May 28, 2018 updated by: Sheba Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: parents counseling
parents counseling guided by the experiment protocol
Behavioral: experimental protocol treatment "The New Authority"
Other Names:
  • "The New Authority" model

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

Juvenile Diabetes Research Foundation

Investigators

  • Study Director: Orit Hamiel, M.D., Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2014

Primary Completion (Actual)

March 30, 2018

Study Completion (Actual)

March 30, 2018

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

March 20, 2014

First Posted (Estimate)

March 21, 2014

Study Record Updates

Last Update Posted (Actual)

May 30, 2018

Last Update Submitted That Met QC Criteria

May 28, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-13-0770-YRK-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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