Resilience Promotion in Teens With Type 1 Diabetes: Preventing Negative Outcomes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

Detailed description: 
      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.

           Hemoglobin A1c will be collected via a small sample of blood and sent to a central
           laboratory. The Diabetes Diagnostic Laboratory at the University of Missouri
           (http://www.diabetes.missouri.edu/)will be used. This laboratory served as the reference
           laboratory for the DCCT and NHANES III and IV studies. They have extensive experience
           serving as a central laboratory for A1c values.

           Continuous glucose monitoring (CGM; iPro sensor and transmitter by Medtronic) will
           assess glycemic variability. The certified diabetes educator (CDE) or study physician
           will assist each participant with the insertion and calibration of the device. For this
           study, adolescents will be blinded to the CGM values for safety reasons; we do not want
           participants adjusting insulin levels or dietary intake based on sensor readings.
           Adolescents will wear the sensor and transmitter for 3 days. After use, the
           sensor/transmitter will be collected by the research team via a pre-paid mailing
           container. Once the transmitter is returned, the data are downloaded to study computers,
           typically with 290 values per day. Investigators then calculate three indicators of
           glycemic variability: SD of the mean of the sensor values, mean amplitude of glycemic
           excursions (MAGE), and percentage of time spent within glucose ranges. The amount of
           time spent "within target" (values between 70 and 180), "below target" (values below
           70), and "above target" (values above 180) will be calculated. All three indicators are
           well-established metrics of glycemic variability.

           Enhancing Treatment Fidelity. Per the NIH Behavior Change Consortium,27 a randomized,
           controlled design is the most effective mechanism for finding treatment effects.
           Further, it is vital to insure all interventions are delivered as proposed and
           participants receive the same treatment dose within and across the intervention
           conditions. To achieve this, Investigators will make uniform reminder calls, use
           treatment manuals, and interventionists will meet every other week with the study PIs
           for group supervision to discuss relevant topics, problem areas, and plans for future
           sessions. Sessions will be audio taped so relevant points can be discussed in
           supervision. Ratings of audiotapes will be conducted by the PIs for 25% of the sessions,
           based on a list of key components.

           Frequent staff trainings is the key to delivering interventions as intended and to
           prevent drift. Therefore, staff training will occur twice annually in years 1-3 and once
           annually in years 4-5. Study PIs will coordinate the trainings which will be delivered
           collectively by the PIs and co-investigators. Training will cover delivery of the
           prevention program, coordinator activities (e.g., processing of blood samples for A1c),
           and treatment fidelity.

        3. Risks: The risks in this study should be minor as many of the intervention components
           have been employed previously in research and clinical settings with minimal adverse
           events. The risks that come along with any study in which emotional and behavioral
           factors are discussed include the possibility of discomfort when completing
           questionnaires and during discussions in the intervention sessions. Further, given the
           nature of diabetes management, stress or patient-parent conflict may occur when
           uncontrolled blood sugars are documented. The research staff is trained to identify such
           distress or discomfort early and provide support in the intervention. Patients agreeing
           to participate in the studies will experience the usual risks associated with the
           treatment of type 1 diabetes: the most significant risk is hypoglycemia, which is
           present for all patients undergoing treatment for diabetes with insulin.

      Another risk associated with this study is the threat to privacy and confidentiality if the
      secured website is somehow breached. However the SNAP software system and the secured
      web-site has been reviewed and approved by CMH's IT officers (Ron Isbell and Jason Ruprecht)
      and CMH's PHI officer (Valerie Witmer), and the PI has been using this secured website in
      another study without difficulties. Participants will access the questionnaires through the
      secured web-site and each participant will be assigned a unique study ID code number. Names,
      initials or other identifying information will not be used on any of the measures.

      There may be other unknown risks for which investigators will monitor. An additional risk is
      the potential threat to privacy and confidentiality. Investigators believe that these
      represent minimal risks as defined by the DHHS office of Human Research Protection.
    

Intervention name(s): Healthy Thinking In Teens; Advanced Diabetes Education.
Intervention type(s): Behavioral; Other
Intervention description(s): 9 sessions. Manualized and group based program. Each session lasts 90 minutes. Sessions occur approximately every other week.; 9 sessions. Manualized and group based program. Each session lasts 90 minutes. Sessions occur approximately every other week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Type 1 diabetes; Adolescent; Resilience; Prevention; Depression