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BREATHE Research Study for Adolescents At-Risk for Depression and Insulin Resistance

Principal Investigator: Eleanor Mackey, Ph.D. (at Children’s National Hospital site)
Status: Recruiting participants
Eligibility Criteria: Adolescents ages 12-17 that have a family member with diabetes and sometimes seem depressed or stressed
Procedure: Interested teens, accompanied by guardian, participate in one to two in-person comprehensive screening visits at Children’s National Hospital. Once deemed eligible, teens will participate in a six-week virtual group program with the potential benefits of: feeling happier and less stressed, learning mindfulness-based or cognitive behavioral skills, learning knowledge about leading a healthier life and decreasing their risk of developing type 2 diabetes. Compensation is provided for teens who take part to thank them for their time.
Funding: NCCIH 1U01AT011008-01
Collaborators: Lauren Shomaker, Ph.D. (lead investigator at Colorado State University); Megan Kelsey, M.D. (co-investigator at University of Colorado); Marian Tanofsky-Kraff, Ph.D. (co-investigator at Uniformed Services University)
Contact: breathe@childrensnational.org, 240-583-1916

BREATHE-T1D: Feasibility Trial of a Mindfulness Based Intervention in Youth with Type 1 Diabetes

Principal Investigator: Eleanor Mackey, Ph.D.
Status: Recruiting participants
Eligibility Criteria: Adolescents ages 12-17 with T1D ≥ 1 year, elevated anxiety or depression
Procedure: The purpose of this study is to adapt and existing mindfulness curriculum to be specific to adolescents with T1D and develop a didactic health education comparison program and to evaluate the feasibility/acceptability of the two programs. Mindfulness intervention content will be delivered via six weekly telemedicine group sessions, followed by a qualitative interview. Adolescents will complete baseline, post-intervention, and three months post-intervention questionnaires on mood, mindfulness, diabetes management and diabetes distress.
Contact: breathet1d@childrensnational.org

Improving Health Communication in Adolescents and Young Adults with Type 1 Diabetes (PREP-DC)

Principal Investigator: Maureen Monaghan, Ph.D.
Status: Analyzing data
Eligibility Criteria: Adolescents and young adults (AYAs) ages 17 through 23 with Type 1 diabetes ≥ one-year duration nearing transition to adult care (within 6 to 12 months)
Procedure: Participants complete questionnaires at two to three consecutive clinic visits in pediatric care and one visit post-transfer to adult care. Each visit with the pediatric healthcare provider is audio recorded. Between the first two clinic visits, AYAs participate in three intervention sessions via videoconference and receive targeted two-way text messages and access to study resources (e.g., website). Intervention sessions focus on communicating health information and preparation for adult diabetes care.
Funding: American Diabetes Association, Pathway to Stop Diabetes Accelerator Award 1-18-ACE-27 (2018-2022)
Contact: prepdc@childrensnational.org

Low-Calorie Sweetened Beverage Restriction in Youth with Type 1 Diabetes

Principal Investigator: Randi Streisand, Ph.D., in collaboration with Allison Sylvetsky, Ph.D. 
Status: Recruiting participants
Eligibility Criteria: Children ages 6 to 12 with Type 1 diabetes for at least one-year duration who use a Dexcom Continuous Glucose Monitoring (GCM) and report consumption of greater than or equal to 12 ounces of Low-Calorie Sweetened Beverages (LCSB) with sucralose or aspartame+ ace-K at least five days out of the week
Procedure: Eligible participants and their parents are followed for 14 weeks. Participants fill out questionnaires and are scheduled for a visit at the Clinical Research Unit (CRU) at Children’s National Hospital. For the two weeks prior to the visit, participants complete texted daily beverage logs, and for the week prior, they complete a daily food and physical activity log. During the baseline visit at the CRU, vitals are obtained, a blood draw and urine sample completed, an MRI performed. Participants are randomized into one of two groups: they are either LCSB restriction, in which they stop the intake of any low-calorie sweeteners; or they are instructed to continue their typical intake of low-calorie sweeteners. After the baseline visit, participants are followed for 12 more weeks and the participants and their parents continue the daily texted beverage logs, complete three more weeks of food and physical activity logs interspersed in different points throughout the study, and have a mid-intervention telehealth visit to reinforce whichever condition they were randomized into. At the end of the intervention, participants return to the CRU to complete another blood draw and urine sample and magnetic resonance imaging (MRI). 
Funding: Sponsored by NIDDK, NIH R21 DK12234501A1
Collaborators: George Washington University
Contact: drinkt1d@gwu.edu

Positive Psychology Intervention to Treat Diabetes Distress in Teens with T1D

Principal Investigator: Randi Streisand, Ph.D., in collaboration with Sarah Jaser, Ph.D. (Vanderbilt University)
Status: Recruiting participants
Eligibility Criteria: Adolescents ages 13 to 17 with type 1 diabetes ≥ one year, together with one parent or caregiver.
Procedure: The purpose of this study is to evaluate a positive psychology intervention for distressed teens with type 1 diabetes to determine the effects on adolescents’ glycemic control and psychosocial outcomes, and to examine the differential impact of the intervention across demographic and treatment variables. The intervention includes eight weeks of supportive text messages to teens with some additional text messages to parents.
Funding: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH), R01DK121316
Contact: thrive@childrensnational.org

ROUTE: Research On the Use of Technology with Education

Principal Investigator: Randi Streisand, Ph.D.
Status: Recruiting participants
Eligibility Criteria: Adolescents ages 10-15 with Type 1 diabetes > six months, together with one parent or caregiver, continuous glucose monitor (CGM) referral from provider
Procedure: The purpose of this study is to evaluate an innovative behavioral intervention that utilizes certified diabetes care and education specialists (CDCES) to teach problem-solving and communication skills around CGM data and use, targeting adolescent-parent T1D interactions related to glucose data, individualized CGM challenges and weekly adolescent-parent joint review of CGM reports. Intervention content will be delivered via three telemedicine sessions with adolescents and a parent (one per month) and supported by connection with a peer parent consultant.
Contact: routet1d@childrensnational.org

Tween Strengths

Principal Investigator: Randi Streisand, Ph.D. in collaboration with Marisa Hilliard, Ph.D. (Texas Children’s/Baylor College of Medicine)
Status: Study development
Eligibility Criteria: Adolescents ages 8-12 with T1D with above-target HbA1c (>8.0%)
Procedure: This study will use a brief intervention targeting multiple systems. Intervention components include interactive strategies and tools to help diabetes care providers, parents and youth identify and bolster T1D-related strengths and self-management behaviors. Specifically:

  • Providers will use data-driven youth profiles to incorporate discussion of youths’ T1D strengths and self-management goals into a diabetes care visit
  • Parents will use a mobile app to track and praise their children’s daily T1D strengths and self-management behaviors
  • Youth will use the app to communicate with their parents about their personal strengths and connect with peers with T1D via strengths-based videos

Patient-reported outcomes (glycemic control, adherence, health-related quality of life, diabetes distress, family conflict and diabetes strengths) and clinical data (BG, A1c, etc.) will be collected at baseline, 6-, 9- and 15-months post-randomization.