NCT02970656

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

February 8, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

April 2, 2019

Status Verified

April 1, 2019

Enrollment Period

2.1 years

First QC Date

November 18, 2016

Last Update Submit

April 1, 2019

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (12)

  • Perceived Stress Scale

    baseline

  • Perceived Stress Scale

    6 months

  • Adolescent Stress Questionnaire (ASQ)

    baseline

  • Adolescent Stress Questionnaire (ASQ)

    6 months

  • Responses to Stress Questionnaire for Diabetes (RSQ)

    baseline

  • +7 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

Teens.ConnectBEHAVIORAL

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)

Teens.Connect

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Nursing

West Haven, Connecticut, 06516-7399, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Margaret Grey, DrPH, RN

    Yale School of Nursing

    PRINCIPAL INVESTIGATOR

  • Jacquelyn Taylor, PhD, PNP-BC

    Yale School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2016

First Posted

November 22, 2016

Study Start

February 8, 2017

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

April 2, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)