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Completed

NCT Number: NCT02093676

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

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba Medical Center

Ramat Gan, Israel

About this study

"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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

experimental protocol treatment "The New Authority"

Behavioral

Other names: "The New Authority" model

Primary outcomes

  1. 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

  1. 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

  2. change in parents' helplessness

    Time frame: assessment at four points: entry, after 3 months, after 6 months and after 9 months

    parents' helplessness questionnaire

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Collaborators

  • Juvenile Diabetes Research Foundation

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 21, 2014
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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