Applying the "New Authority" Model in the Treatment of Po... | NCT02093676

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

NCT02093676

Sponsor

Sheba Medical Center

Status

Completed

Last Update Posted

May 30, 2018Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Type 1 Diabetes

Interventions

experimental protocol treatment "The New Authority"

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 30, 2014Actual

Primary Completion Date

Mar 30, 2018Actual

Completion Date

Mar 30, 2018Actual

First Submitted Date

Feb 27, 2014

First Submission Date that Met QC Criteria

Mar 20, 2014

First Posted Date

Mar 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2018

Last Update Posted Date

May 30, 2018Actual

Name	Class
Juvenile Diabetes Research Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
parents counseling	Experimental	parents counseling guided by the experiment protocol	Behavioral: experimental protocol treatment "The New Authority"

Interventions

Name	Type	Description	Arm Group Labels	Other Names
experimental protocol treatment "The New Authority"	Behavioral		parents counseling	"The New Authority" model

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
change in reported adherence	self care inventory questionnaire	assessment at four points: entry, after 3 months, after 6 months and after 9 months
change in parents' helplessness	parents' helplessness questionnaire

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Orit Hamiel, M.D.	Sheba Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Ramat Gan			Israel

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided