NCT02093676

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

July 30, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

3.7 years

First QC Date

February 27, 2014

Last Update Submit

May 28, 2018

Conditions

Type 1 Diabetes

Keywords

diabetestype 1adolescentsparents counselling

Outcome Measures

Primary Outcomes (1)

  • change in self monitoring of blood glucose

    assessment at 4 points: enrty, after 3 months, after 6 months and after 9 months

Secondary Outcomes (4)

  • change in reported adherence

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

  • change in parents' helplessness

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

  • change in family conflict

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

  • change in parental monitoring

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

Study Arms (1)

parents counseling

EXPERIMENTAL

parents counseling guided by the experiment protocol

Behavioral: experimental protocol treatment "The New Authority"

Interventions

experimental protocol treatment "The New Authority"BEHAVIORAL
Also known as: "The New Authority" model
parents counseling

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Orit Hamiel, M.D.

    Sheba Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2014

First Posted

March 21, 2014

Study Start

July 30, 2014

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

IL(1)