跳至主要内容
临床试验/NCT01490619
NCT01490619已完成不适用

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

Ann & Robert H Lurie Children's Hospital of Chicago2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
280
试验地点
2
主要终点
Change in Depressive symptoms from baseline to post intervention and change in Depressive symptoms over the two year study period.

研究概览

简要总结

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.

详细描述

  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. Not surprisingly, adolescents are at increased risk for anxiety and depressive symptoms, poor coping and problem-solving skills, poor regimen adherence, and negative diabetes-specific health outcomes. The mental and physical health risks of T1D add to its already staggering economic burden; the annual cost of diabetes in the United States for direct medical care exceeds $116 billion and individuals with diabetes have twice the healthcare costs of their peers without diabetes.

A handful of psychological interventions targeting adolescents' poor behavioral and emotional functioning demonstrate beneficial effects on disease management and outcomes. However, no prevention programs exist that equip adolescents with behavioral skills and cognitive strategies shown to reduce both the risk of poor psychological functioning and the risk of negative health outcomes over time. Although none of the effective prevention programs developed for healthy youth have been adapted for adolescents with T1D, the Penn Resilience Program (PRP) is a viable candidate because it is a well-established prevention program shown to promote resilience and prevent depression. The current study will test a diabetes-specific adaptation of PRP for adolescents with T1D and fill a significant gap in the scientific literature.

This study's significance lies not only in its focus on preventing depression, a prevalent, critical factor influencing diabetes-specific health outcomes, but also in its emphasis on ultimately preventing suboptimal glycemic control, a common, expensive, and dangerous problem in pediatric diabetes. Individuals with both depression and diabetes incur 4.5 times the health care costs as those with diabetes alone. The focus of the intervention on resilience promotion is innovative because of its potential to fundamentally change risk for depression and set adolescents on a trajectory toward improved adherence and health outcomes. Moreover, documenting the mechanisms of change that impact critical psychosocial and health outcomes in youth with T1D via a longitudinal, randomized, controlled design facilitates generalizability to other chronically ill populations given similar management demands on the individual and family, and associations with depression. 2. Summary of Procedures: Investigators will employ a randomized, controlled design and compare PRP T1D to a diabetes education intervention, (EI; developed by two CDE's, specifically focused on adolescent learning and adolescent needs) on resilience characteristics, depressive symptoms, adherence behaviors, and glycemic outcomes. Investigators will recruit 280 adolescents with T1D across two cities (Chicago and Cincinnati), measuring outcomes at baseline, post-intervention, and at five surveillance visits spanning an additional 24 months. All adolescents will participate in 9 sessions, lasting approximately 90 minutes each session. Assessments occur at baseline (0 months), post-intervention (4.5 months), and during the surveillance period (8, 12, 16, and 28 months).

PRP T1D will be led by master's level graduate students enrolled in clinical psychology PhD programs. EI will be led by CDE nurses. This EI group is preferable to either untreated control or wait-list control groups as it allows for the experimental control of attention, peer group sessions, and dose on treatment outcomes. Both program leaders will receive over 20 hours of training in the program they are leading.

Data Collection and Measures. Measures assess two primary outcomes (depressive symptoms and glycemic control) and two mechanisms of change (resilience and adherence). Assessments occur at baseline, post-intervention (4.5 months), and 4 surveillance visits (8, 12, 16, and 28 months). To keep participant burden at a manageable level and to increase retention rate, all eligible families will be invited to complete the questionnaires on a secured web-site that they can access while with the research study staff, or while at home, work, in a public library or while in clinic. Investigators will use the SNAP Survey Software system, which allows for electronic completion of surveys with data directly transferred to data management software in a HIPAA-protected framework. The SNAP software eliminates the need for manual data entry, reducing the risk of missing data as well as reducing the risk of violating the confidentiality of the data.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: baseline, 4.5 months, 8.5 months, 12.5 months, 16.5 months, and 28.5 months

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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jill Weissberg-Benchell, Ph.D.

Attending Psychologist, Department of Psychiatry

Ann & Robert H Lurie Children's Hospital of Chicago

研究点 (2)

Loading locations...

相似试验