- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00358059
Behavior Therapy for Families of Diabetic Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
Florida
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Jacksonville, Florida, United States, 32207
- Nemours Children's Clinic
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University in St. Louis School of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Age of adolescent 12-<17 years Type 1 diabetes for >2 years Living in a home environment English reading ability at 5th grade level or above Established diabetes care at participating site Working telephone service Intent to remain living in same region for next 18 months -
Exclusion Criteria:
Presence of another chronic systemic disease Inpatient psychiatric treatment of patient or caregiver in prior 6 months Current outpatient treatment of psychosis, major depression or substance use disorder in parent/caregiver
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Treatment adherence
|
Glycosylated hemoglobin (HbA1c)
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Secondary Outcome Measures
Outcome Measure |
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Parent-adolescent communication
|
Family problem solving and conflict resolution skills
|
Diabetes-related quality of life
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tim Wysocki, Ph.D., Nemours Children's Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DK043802 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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