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Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families

NCT05268250 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-10-30

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

R2D2 mHealth intervention

R2D2 mHealth treatment will use cognitive behavioral therapy, mindfulness, and behavioral activation strategies

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    collaborator OTHER

  • Nemours Children's Clinic

    lead OTHER

Principal Investigators

  • Susana R Patton, PhD · Nemours Children's Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-26
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05268250 on ClinicalTrials.gov