Type 1 DiabetesNCT02093676
Applying the "New Authority" Model in the Treatment of Poorly Controlled Diabetic Adolescents and Their Families
A study testing experimental protocol treatment "The New Authority" in people with Type 1 Diabetes, run by Sheba Medical Center at 1 site in Israel.
Trial summary
It is presumed that families of poorly controlled diabetic adolescents (type 1) would benefit from parents' counselling, guided by "the New Authority" model. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- experimental protocol treatment "The New Authority"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Jul 2014to 30 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of diabetes type 1
- condition duration a year or more
Who cannot join
- family does not speak Hebrew
- adolescent doesn't live at home
- serious psychiatric condition in the family
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- experimental protocol treatment "The New Authority"
- Keywords
- diabetes, type 1, adolescents, parents counselling
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental protocol treatment "The New Authority"Behavioural
Also called "The New Authority" model
| Study group | Role | What they receive |
|---|---|---|
| parents counseling | Experimental | parents counseling guided by the experiment protocol Receives: Behavioral: experimental protocol treatment "The New Authority" |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in self monitoring of blood glucose
Measured: assessment at 4 points: enrty, after 3 months, after 6 months and after 9 months
Secondary outcomes (4)
change in reported adherence
self care inventory questionnaire
Measured: assessment at four points: entry, after 3 months, after 6 months and after 9 months
change in parents' helplessness
parents' helplessness questionnaire
Measured: assessment at four points: entry, after 3 months, after 6 months and after 9 months
change in family conflict
diabetes family conflict scale
Measured: assessment at four points: entry, after 3 months, after 6 months and after 9 months
change in parental monitoring
parental monitoring of diabetes
Measured: assessment at four points: entry, after 3 months, after 6 months and after 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study start30 Jul 2014
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
- Investigators
- Orit Hamiel, M.D., Study director, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093676
- Sponsor's protocol ID
- SHEBA-13-0770-YRK-CTIL
- Status last verified
- May 2018
- First submitted
- 27 Feb 2014
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Assessment of a Treatment Protocol for Poorly Controlled Diabetic (Type 1) Adolescents, Based on "The New Authority" Model
- ClinicalTrials.gov ID
- NCT02093676
- Acronym / sponsor ID
- SHEBA-13-0770-YRK-CTIL
- Conditions
- Type 1 Diabetes
- Keywords
- diabetes, type 1, adolescents, parents counselling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- 30 Jul 2014 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| parents counseling | Experimental | Behavioral: experimental protocol treatment "The New Authority"parents counseling guided by the experiment protocol |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- diagnosis of diabetes type 1
- condition duration a year or more
Key exclusion criteria (3 listed)
- family does not speak Hebrew
- adolescent doesn't live at home
- serious psychiatric condition in the family
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimental protocol treatment "The New Authority"Also: "The New Authority" model | Behavioural | parents counseling |
Primary outcome
change in self monitoring of blood glucose
Time frame: assessment at 4 points: enrty, after 3 months, after 6 months and after 9 months
4 secondary outcomes
change in reported adherence
Time frame: 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
change in family conflict
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orit Hamiel, M.D. study director
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental protocol treatment "The New Authority" in people with Type 1 Diabetes, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in self monitoring of blood glucose (time frame: assessment at 4 points: enrty, after 3 months, after 6 months and after 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.