A Pilot Study of Biomarkers of Stress in Youth Who Use Teens.Connect

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

A Pilot Study of Biomarkers of Stress in Youth Who Use Teens.Connect

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970656
• Other study ID #: 1503015414
• Status: Completed
• Phase: N/A
• Start date: February 8, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: April 2019
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

Inclusion Criteria:

• diagnosed with T1D for at least 6 months;

• age 11 to 14 years

• naïve to TEENCOPE and/or Managing Diabetes

• assent and parent/guardian consent to participate in the study

Exclusion Criteria:

• medical condition that impacts cortisol functioning

• takes medications that impact cortisol, except diabetes medications

• sleeps less than 6 hours per night

• smokes

• takes oral contraceptives

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• Teens.Connect
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)

Locations

Country	Name	City	State
United States	Yale School of Nursing	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Miller Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated Hemoglobin (HbA1c)	Bayer Diagnostics DCA2000® (normal range = 4.2-6.3%)	baseline
Primary	Glycosylated Hemoglobin (HbA1c)	Bayer Diagnostics DCA2000® (normal range = 4.2-6.3%)	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Awakening and sleep time	wrist-worn accelerometer	over 3 days at baseline
Secondary	Awakening and sleep time	wrist-worn accelerometer	over 2 days at 6 months
Secondary	Genotype & DNA Methylation	Saliva collection	baseline
Secondary	DNA Methylation	Saliva collection	6 months