A Pilot Study of Biomarkers of Stress in Youth Who Use Teens.Connect
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This feasibility/pilot study has three purposes. First, the investigators will determine the
      feasibility of collecting saliva to measure stress biomarkers over three days at home in
      youth. Second, the investigators will conduct a pilot study of the Teens.Connect Internet
      program for youth with type 1 diabetes to determine whether changes in stress biomarkers
      associate with self-reported perceived stress and HbA1c. Third, the investigators will
      examine the gene-environment interaction of the top 14 targeted candidate genes and
      epi-genome wide effects of teens' stress biomarkers and its influence on blood glucose levels
      over time.
    

Detailed description: 
      Intensive management of type 1 diabetes (T1D) among youth as recommended by the American
      Diabetes Association requires a complex set of self-management activities that create high
      levels of perceived stress in youth and families. In individuals exposed to chronic stress,
      such as that of a chronic condition, the body responds with physiological and hormonal
      responses to adapt. These responses can be harmful (e.g., higher glucose levels, higher
      HbA1c). Such harmful effects may be ameliorated by programs that reduce psychosocial stress.

      The investigators have found an Internet-delivered coping skills training program combined
      with a diabetes education program significantly improved HbA1c and QOL for youth with T1D.
      Self-reported perceived stress mediated these outcomes. There has been little to no
      examination, however, of whether a reduction in self-reported perceived stress is associated
      with a reduction in biochemical markers of stress which could explain the positive impact on
      HbA1c. It is critically important to understand the physiologic as well as the psychosocial
      mechanisms associated with such interventions in order to improve glycemic control in youth
      with this chronic autoimmune condition. If such interventions affect biomarkers of stress, it
      would be important to strengthen the stress reduction activities embedded in such
      interventions, such as meditation, to further improve metabolic control. Thus, aims of this
      pilot/feasibility study are to:

        1. Determine the feasibility and reliability of collection of saliva for the measurement of
           three stress biomarkers at awakening and 30-45 minutes later over 3 days at home in 20
           youth (age 11-14 years). These biomarkers include cortisol to assess
           hypothalamic-pituitary-adrenal axis functioning; alpha-amylase (s-AA) to assess the
           sympathetic-adrenal-medullary system, and salivary immunoglobulin A (s-IgA) to assess
           stress-related immune changes. This aim will allow the investigators to determine the
           feasibility of recruiting youth to provide such data in a larger trial by assessing the
           percent of youth who agree to participate and adhere to the salivary collection
           protocol, using actigraphy to document awakening time and Medication Event Monitoring
           System (MEMS) caps monitoring to determine time of salivary collection. Patterns and
           variability of stress biomarker levels over 3 days will be used to assess
           intra-individual variability and relationships with self-reported daily stressors and
           self-reported perceived stress.

        2. Conduct a pilot study of Teens.Connect, a combination of the investigators' previous
           TEENCOPE™ and Managing Diabetes programs with 40 youth to determine whether alterations
           in stress biomarkers are associated with self-reported perceived stress and HbA1c.

        3. Assess epigenetic components of these responses by examining the gene-environment
           interaction of the top 14 targeted candidate genes and epigenome wide effects of teens'
           stress biomarkers and their influence on HbA1c levels over time. Candidate genes will be
           measured at baseline and DNA methylation patterns will be measured at baseline and then
           again at 6 months follow-up using the Oragene saliva collection kits.
    

Intervention name(s): Teens.Connect
Intervention type(s): Behavioral
Intervention description(s): Teens.Connect combines two internet psycho-educational programs, TEENCOPE™, an internet version of coping skills training using a graphic novel format combined with social media, and an internet diabetes problem-solving educational program (Managing Diabetes)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment