Diabetes Mellitus, Type 1NCT02970656
A Pilot Study of Biomarkers of Stress in Youth Who Use Teens.Connect
A study testing Teens.Connect in people with Diabetes Mellitus, Type 1, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Teens.Connect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2017to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Nursing
West Haven, Connecticut, 06516-7399
About this study
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.
Read the 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:
- 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.
- 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.
- 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Teens.Connect
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teens.ConnectBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Teens.Connect |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated Hemoglobin (HbA1c)
Bayer Diagnostics DCA2000® (normal range = 4.2-6.3%)
Measured: baseline
Glycosylated Hemoglobin (HbA1c)
Bayer Diagnostics DCA2000® (normal range = 4.2-6.3%)
Measured: 6 months
Secondary outcomes (12)
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.
Measured: baseline
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: over 2 days at 6 months
Awakening and sleep time
wrist-worn accelerometer
Measured: over 3 days at baseline
Awakening and sleep time
wrist-worn accelerometer
Measured: over 2 days at 6 months
Genotype & DNA Methylation
Saliva collection
Measured: baseline
DNA Methylation
Saliva collection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study start8 Feb 2017
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Miller Foundation
- Responsible party
- Sponsor
- Investigators
- Margaret Grey, DrPH, RN, Principal investigator, Yale School of NursingJacquelyn Taylor, PhD, PNP-BC, Principal investigator, Yale School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970656
- Sponsor's protocol ID
- 1503015414
- Status last verified
- Apr 2019
- First submitted
- 18 Nov 2016
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Biomarkers of Stress in Youth Who Use Teens.Connect
- ClinicalTrials.gov ID
- NCT02970656
- Acronym / sponsor ID
- 1503015414
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Miller Foundation
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teens.Connect | Experimental | Behavioral: Teens.ConnectThe 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. |
| 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. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teens.ConnectTeens.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) | Behavioural | Teens.Connect |
Primary outcome
Glycosylated Hemoglobin (HbA1c)
Time frame: baseline
Bayer Diagnostics DCA2000® (normal range = 4.2-6.3%)
Glycosylated Hemoglobin (HbA1c)
Time frame: 6 months
Bayer Diagnostics DCA2000® (normal range = 4.2-6.3%)
12 secondary outcomes
Perceived Stress Scale
Time frame: baseline
Perceived Stress Scale
Time frame: 6 months
Adolescent Stress Questionnaire (ASQ)
Time frame: baseline
Adolescent Stress Questionnaire (ASQ)
Time frame: 6 months
Responses to Stress Questionnaire for Diabetes (RSQ)
Time frame: baseline
Responses to Stress Questionnaire for Diabetes (RSQ)
Time frame: 6 months
Stress Biomarkers
Time frame: over 3 days at baseline
Stress Biomarkers
Time frame: over 2 days at 6 months
Awakening and sleep time
Time frame: over 3 days at baseline
Awakening and sleep time
Time frame: over 2 days at 6 months
Genotype & DNA Methylation
Time frame: baseline
DNA Methylation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Grey, DrPH, RN principal investigator
Yale School of Nursing
Jacquelyn Taylor, PhD, PNP-BC principal investigator
Yale School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teens.Connect in people with Diabetes Mellitus, Type 1, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated Hemoglobin (HbA1c) (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.