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

NCT01490619 | Completed DMC

• 1 other identifier: R01DK090030-01A1
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes; Adolescent; Resilience; Prevention; Depression

Outcome Measures

Primary Outcomes (1)

• Change in Depressive symptoms from baseline to post intervention and change in Depressive symptoms over the two year study period.

  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.

  baseline, 4.5 months, 8.5 months, 12.5 months, 16.5 months, and 28.5 months

Secondary Outcomes (1)

• Change in Glycemic Control from baseline to post-intervention and change in Glycemic Control over time during the two year study period.

  baseline, 4.5 months, 8.5 months, 12.5 months, 16.5 months and 28.5 months

Study Arms (2)

Healthy Thinking in Teens

EXPERIMENTAL

Group-based, manualized program, based on cognitive behavioral therapy techniques.

Behavioral: Healthy Thinking In Teens

Advanced Diabetes Education

ACTIVE COMPARATOR

Group-based, manualized program designed to provide diabetes education, focused on adolescent-specific topics.

Other: Advanced Diabetes Education.

Interventions

Healthy Thinking In Teens BEHAVIORAL

9 sessions. Manualized and group based program. Each session lasts 90 minutes. Sessions occur approximately every other week.

Healthy Thinking in Teens

Advanced Diabetes Education. OTHER

9 sessions. Manualized and group based program. Each session lasts 90 minutes. Sessions occur approximately every other week.

Advanced Diabetes Education

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann and Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• Shapiro JB, Bryant FB, Holmbeck GN, Hood KK, Weissberg-Benchell J. Do baseline resilience profiles moderate the effects of a resilience-enhancing intervention for adolescents with type I diabetes? Health Psychol. 2021 May;40(5):337-346. doi: 10.1037/hea0001076.

  PMID: 34152787 DERIVED

• Hood KK, Iturralde E, Rausch J, Weissberg-Benchell J. Preventing Diabetes Distress in Adolescents With Type 1 Diabetes: Results 1 Year After Participation in the STePS Program. Diabetes Care. 2018 Aug;41(8):1623-1630. doi: 10.2337/dc17-2556. Epub 2018 Jun 19.

  PMID: 29921624 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Depression

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Jill Weissberg-Benchell, PhD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Psychologist, Department of Psychiatry

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 13, 2011
• Study Start: October 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: March 30, 2018
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

US (1)