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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Nemours Children's Clinic
Study ID
NCT05268250
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • R2D2 mHealth intervention — BEHAVIORAL
    R2D2 mHealth treatment will use cognitive behavioral therapy, mindfulness, and behavioral activation strategies

Study Details

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.

Key Dates

Start date
Feb 26, 2024
Status verified
Jul 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

youth glycated hemoglobin (HbA1c) [ Time Frame: week 0, week 13 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Nemours Children's HealthJacksonvilleFlorida32207
Susana R Patton, PhD
[email protected]
9136973595
Amy Milkes
[email protected]
Children's Mercy Kansas CityKansas CityMissouri64108
Mark Clements, MD PHD
[email protected]
8162343000

Find similar trials in Jacksonville, FL

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Nemours Children's Health· Jacksonville, FLChildren's Mercy Kansas City· Kansas City, MO

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