Resilience Promotion in Teens With Type 1 Diabetes: Preventing Negative Outcomes

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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 a handful of psychological interventions targeting adolescents' poor behavioral and emotional functioning demonstrate beneficial effects on disease management and outcomes, no prevention programs exist that equip adolescents with behavioral skills and cognitive strategies necessary to reduce these risks. Therefore, the proposed research will test whether a diabetes-specific adaptation of a resilience promoting, depression-prevention intervention for adolescents with type 1 diabetes will reduce both the risk of poor psychological functioning and the risk of negative health outcomes over time.

Key facts

Study ID

NCT01490619

Run by

Ann & Robert H Lurie Children's Hospital of Chicago

People needed

280

Starts

2011-10-01

Expected to finish

2018-03-30

Last updated by the study team

2020-01-27

Who can join

Age: 14 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ann and Robert H Lurie Children's Hospital of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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