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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jill Weissberg-Benchell, Ph.D., Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01490619
First received: December 7, 2011
Last updated: July 29, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490619

Locations
United States, Illinois
Ann and Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

No publications provided

Responsible Party: Jill Weissberg-Benchell, Ph.D., Attending Psychologist, Department of Psychiatry, 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: July 29, 2014
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
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014