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| Name | Class |
|---|---|
| Miller Foundation | UNKNOWN |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teens.Connect | Experimental | The Teens-Connect internet-based program has two complementary components - TEENCOPE and Managing Diabetes. Managing Diabetes consists of 5 sessions on educational content related to diabetes self management targeted to adolescents. TEENCOPE consists of a series of 5 sessions designed to increase children's sense of competence and mastery by retraining inappropriate or non-constructive coping styles and forming more positive styles and patterns of behavior. Each week a new 30-45 minute session is uploaded to a password-protected website on the Yale server for youth to complete. Youth are grouped with 8-12 peers who complete the same weekly sessions in an asynchronous manner. Youth interact with each other on an online discussion board moderated by a clinical psychologist. |
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| Control | No Intervention | Wait listing will serve as the control condition. Usual care at the Yale Pediatric Diabetes Center consists of quarterly visits with physicians and nurse practitioners, accessibility to nutritional and psychological consultation, and 24/7 on call service. Following completion of the 6 month data point, youth will be offered the opportunity to participate in the internet program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teens.Connect | Behavioral | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated Hemoglobin (HbA1c) | Bayer Diagnostics DCA2000® (normal range = 4.2-6.3%) | baseline |
| Glycosylated Hemoglobin (HbA1c) | Bayer Diagnostics DCA2000® (normal range = 4.2-6.3%) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale | A 14-item scale that measures the degree to which situations in one's life are appraised as stressful. Items assess feelings of stress, hassles, and coping during the past month. Respondents rate items on a 5-point Likert scale ranging from 0 (never) to 4 (very often), with higher scores indicative of greater perceived stress and less effective coping. | baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Grey, DrPH, RN | Yale School of Nursing | Principal Investigator |
| Jacquelyn Taylor, PhD, PNP-BC | Yale School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Nursing | West Haven | Connecticut | 06516-7399 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Perceived Stress Scale | A 14-item scale that measures the degree to which situations in one's life are appraised as stressful. Items assess feelings of stress, hassles, and coping during the past month. Respondents rate items on a 5-point Likert scale ranging from 0 (never) to 4 (very often), with higher scores indicative of greater perceived stress and less effective coping. | 6 months |
| Adolescent Stress Questionnaire (ASQ) | A 94-item inventory of common adolescent stressors. Each item (stressor) is rated on a 5-point Likert scale where 1=Not at all stressful (or is irrelevant to me); 2=A little stressful; 3=Moderately stressful; 4=Quite stressful; and 5=Very stressful. | baseline |
| Adolescent Stress Questionnaire (ASQ) | A 94-item inventory of common adolescent stressors. Each item (stressor) is rated on a 5-point Likert scale where 1=Not at all stressful (or is irrelevant to me); 2=A little stressful; 3=Moderately stressful; 4=Quite stressful; and 5=Very stressful. | 6 months |
| Responses to Stress Questionnaire for Diabetes (RSQ) | A 69-item scale asking the participant to report frequency of diabetes related stressors (12 items) and their responses to those stressors (57 items). Frequencies are reported on a 4-point scale ranging from 0 (never) to 3 (almost every day) for stressors, and 1 (not at all) to 4 (a lot) for stress responses. | baseline |
| Responses to Stress Questionnaire for Diabetes (RSQ) | A 69-item scale asking the participant to report frequency of diabetes related stressors (12 items) and their responses to those stressors (57 items). Frequencies are reported on a 4-point scale ranging from 0 (never) to 3 (almost every day) for stressors, and 1 (not at all) to 4 (a lot) for stress responses. | 6 months |
| Stress Biomarkers | cortisol, alpha-amylase (s-AA), and salivary immunoglobulin A (s-IgA) determined by salivary collection at awakening and 30-45 minutes later over 3 days | over 3 days at baseline |
| Stress Biomarkers | cortisol, alpha-amylase (s-AA), and salivary immunoglobulin A (s-IgA) determined by salivary collection at awakening and 30-45 minutes later over 2 days | over 2 days at 6 months |
| Awakening and sleep time | wrist-worn accelerometer | over 3 days at baseline |
| Awakening and sleep time | wrist-worn accelerometer | over 2 days at 6 months |
| Genotype & DNA Methylation | Saliva collection | baseline |
| DNA Methylation | Saliva collection | 6 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |