Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This R01 is in response to RFA-DK-19-021, Treating Diabetes Distress to Improve Glycemic Outcomes in Type 1 Diabetes. The objective is to test the feasibility and acceptability of a novel, practical, and potentially scalable screen to treat program for diabetes distress in families of school-age children with T1D (called Remedy to Diabetes Distress \[R2D2\]) and to test the initial efficacy of R2D2 to reduce diabetes distress to improve children's glycemic control.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 65
Healthy Volunteers: f
View:
• child age between 8-12 years, physician confirmed T1D diagnosis,
• either the child or the parent or both the child and parent report diabetes distress levels at or above clinical cut-points,
• child is on an intensive insulin regimen (pump or MDI).
Locations
United States
Florida
Nemours Children's Health
RECRUITING
Jacksonville
Missouri
Children's Mercy Kansas City
RECRUITING
Kansas City
Contact Information
Primary
Susana R Patton, PhD
susana.patton@nemours.org
9046972000
Backup
Amy Milkes
amy.milkes@nemours.org
Time Frame
Start Date: 2024-02-26
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 180
Treatments
Experimental: R2D2 mHealth treatment for diabetes distress
This is a mHealth supported, cognitive behavioral treatment for parents and school-age children who were identified with clinically relevant levels of diabetes distress as part of a clinic screening program
No_intervention: Standard Care Control
Parents and school-age children who were identified with clinically relevant levels of diabetes distress as part of a clinic screening program will receive local resources (print or electronic).
Related Therapeutic Areas
Sponsors
Collaborators: Children's Mercy Hospital Kansas City
Leads: Nemours Children's Clinic