Type 1 DiabetesNCT00946517
Impaired Family Dynamics Leads to Non Compliance in Type I Diabetes
An observational study of Type 1 Diabetes, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This study will test the hypothesis that certain parenting styles are associated with greater non-adherence to therapy in children and teens with type 1 diabetes. To test their hypothesis, the investigators will use standardized and validated questionnaires for parents and children to determine: parenting styles (the… Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Questionnaires
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to May 2010
- Phase
- Observational
- 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 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Endocrinology clinic patients
Who may be able to join
- Type 1 diabetics
- Aged 9 - 18 years
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This study will test the hypothesis that certain parenting styles are associated with greater non-adherence to therapy in children and teens with type 1 diabetes. To test their hypothesis, the investigators will use standardized and validated questionnaires for parents and children to determine: parenting styles (the investigators will measure parental strictness, parental attachment, and parental monitoring), parent ability to cope with stress, parent comfort with the parenting role, parent and child level of depression and parent perception of financial resources. The investigators will also measure parent and child's perception of the child's underlying temperament and parent-child conflict. The investigators will correlate these findings with both parent and child subjective measures of adherence to therapy. The investigators will also obtain objective measures of therapy adherence including: HbA1c, number of hospitalizations for diabetes ketoacidosis and number of missed outpatient appointments. These measures will be correlated with our other findings.
- Conditions
- Type 1 Diabetes
- Being tested
- Questionnaires
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Parenting and behavioral questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Parents | Parents or caregivers of type 1 diabetics Receives: Other: Questionnaires | |
| Child | Type 1 diabetics Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting styles
Measured: Baseline
Secondary outcomes (2)
Child behavior traits
Measured: Baseline
Adherence to therapy
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: PI left the institution
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 Nationwide Children's HospitalThe 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
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana S Hardin, MD, Principal investigator, The Research Institute at Nationwide Children's Hospital, The Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946517
- Sponsor's protocol ID
- IRB09-00224
- Status last verified
- May 2015
- First submitted
- 24 Jul 2009
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impaired Family Dynamics Leads to Non Compliance in Type I Diabetes
- ClinicalTrials.gov ID
- NCT00946517
- Acronym / sponsor ID
- IRB09-00224
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left the institution
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 27 Jul 2009 (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.
This study will test the hypothesis that certain parenting styles are associated with greater non-adherence to therapy in children and teens with type 1 diabetes. To test their hypothesis, the investigators will use standardized and validated questionnaires for parents and children to determine: parenting styles (the investigators will measure parental strictness, parental attachment, and parental monitoring), parent ability to cope with stress, parent comfort with the parenting role, parent and child level of depression and parent perception of financial resources. The investigators will also measure parent and child's perception of the child's underlying temperament and parent-child conflict. The investigators will correlate these findings with both parent and child subjective measures of adherence to therapy. The investigators will also obtain objective measures of therapy adherence including: HbA1c, number of hospitalizations for diabetes ketoacidosis and number of missed outpatient appointments. These measures will be correlated with our other findings.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents | – | Other: QuestionnairesParents or caregivers of type 1 diabetics |
| Child | – | Other: QuestionnairesType 1 diabetics |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Endocrinology clinic patients
Key inclusion criteria (2 listed)
- Type 1 diabetics
- Aged 9 - 18 years
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| QuestionnairesParenting and behavioral questionnaires | Other | Child, Parents |
Primary outcome
Parenting styles
Time frame: Baseline
2 secondary outcomes
Child behavior traits
Time frame: Baseline
Adherence to therapy
Time frame: Baseline
Results and safety
The study was stopped early (reason given: PI left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Dana S Hardin, MD principal investigator
The Research Institute at Nationwide Children's Hospital, The Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Nationwide Children's Hospital at 1 site in United States.
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 1 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: stopped early, as of the sponsor's last update on 15 May 2015. 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 United States. 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 was stopped early (reason given: PI left the institution). Results are not available in the source record.
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?
Parenting styles (time frame: Baseline). 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 15 May 2015.