Resilience Promotion in Teens With Type 1 Diabetes: Preventing Negative Outcomes
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 1 Diabetes |
Behavioral: Healthy Thinking In Teens Other: Advanced Diabetes Education. |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Resilience Promotion in Teens With Type 1 Diabetes: Preventing Negative Outcomes |
- Change in Depressive symptoms from baseline to post intervention and change in Depressive symptoms over the two year study period. [ Time Frame: baseline, 4.5 months, 8.5 months, 12.5 months, 16.5 months, and 28.5 months ] [ Designated as safety issue: No ]Investigators expect that Depressive symptoms will change over time. Specifically, it is expected that depressive symptoms will not increase and may even decrease in the Healthy Thinking in Teens arm, whereas depressive symptoms will increase in the Advanced Diabetes Education arm.
- Change in Glycemic Control from baseline to post-intervention and change in Glycemic Control over time during the two year study period. [ Time Frame: baseline, 4.5 months, 8.5 months, 12.5 months, 16.5 months and 28.5 months ] [ Designated as safety issue: No ]Hemoglobin A1C. Investigators expect that Hemoglobin A1C will change over time. Specifically, it is expected that Hemoglobin A1c will increase more in the Advanced Diabetes Education Arm than it will in the Healthy Thinking in Teens arm.
| Estimated Enrollment: | 280 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | September 2016 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Healthy Thinking in Teens
Group-based, manualized program, based on cognitive behavioral therapy techniques.
|
Behavioral: Healthy Thinking In Teens
9 sessions. Manualized and group based program. Each session lasts 90 minutes. Sessions occur approximately every other week.
|
|
Active Comparator: Advanced Diabetes Education
Group-based, manualized program designed to provide diabetes education, focused on adolescent-specific topics.
|
Other: Advanced Diabetes Education.
9 sessions. Manualized and group based program. Each session lasts 90 minutes. Sessions occur approximately every other week.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 14 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 Criteria:
- 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.
Contacts and Locations| Contact: Jill Weissberg-Benchell, Ph.D. | 773-880-4818 | jwbenchell@childrensmemorial.org |
| Contact: Korey Hood, Ph.D. | 513-803-0405 | Korey.Hood@cchmc.org |
| United States, Illinois | |
| Children's Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| Contact: Jill Weissberg-Benchell, Ph.D. 773-880-4818 jwbenchell@childrensmemorial.org | |
| Principal Investigator: Jill Weissberg-Benchell, Ph.D. | |
More Information
No publications provided
| Responsible Party: | Ann & Robert H Lurie Children's Hospital of Chicago |
| ClinicalTrials.gov Identifier: | NCT01490619 History of Changes |
| Other Study ID Numbers: | RO1 DK 090030 01A1 |
| Study First Received: | December 7, 2011 |
| Last Updated: | December 9, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
|
Type 1 diabetes Adolescent Resilience Prevention Depression |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013