Status:
COMPLETED
Resilience Promotion in Teens With Type 1 Diabetes: Preventing Negative Outcomes
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
14-18 years
Phase:
NA
Brief Summary
Adolescents with type 1 diabetes are at increased risk for depressive symptoms, poor coping and problem-solving skills, poor regimen adherence, and negative diabetes-specific health outcomes. Although...
Detailed Description
1. Scope of Problem: Adolescents with type 1 diabetes (T1D) must balance a complex daily treatment regimen while also facing the emotional, social and academic demands of this developmental period. No...
Eligibility Criteria
Inclusion
- Study participants will meet the following inclusion criteria:
- 14-18 years old,
- diagnosis of T1D according to ADA criteria for at least 1 year,
- daily insulin dosing of at least 0.5 units per kilogram per day,
- fluent in English, and
- provide assent to participate.
Exclusion
- other chronic, physical disease or condition except for celiac or thyroid disease,
- diagnosis of major depressive disorder determined at screening visit,
- current treatment with an antidepressant,
- diagnosis of major mental disorder (e.g., bipolar disorder, thought disorder, anorexia nervosa),
- diagnosis of developmental disorder (e.g., mental retardation, autism, asperger's), or ward of the state.
- Adolescents must have established T1D, uncomplicated by other chronic diseases so any observed changes in glycemic control during the study cannot be attributed to other diseases or to endogenous insulin production seen in the 'honeymoon' period.28 Adolescents cannot have a diagnosis of major depressive disorder because that diagnosis warrants more intensive intervention. Further, adolescents cannot be on antidepressant medication treatment at the time they start the trial because it may impact psychological outcomes and cause unmeasured treatment effects. Finally, adolescents need to be without developmental or learning problems as that may make participation difficult, especially in a group format.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2018
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT01490619
Start Date
October 1 2011
End Date
March 30 2018
Last Update
January 27 2020
Active Locations (1)
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1
Ann and Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611