Type 1 Diabetes (T1D) Clinical Trials

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Feasibility of REAL-Fam to Support Diabetes Self-Management, Family Participation, and Child Health

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to learn if the REAL-Fam occupational therapy intervention is feasible to study in a larger-scale randomized controlled trial. It will also seek to understand how the intervention influences how a rural family participates in and manages their child's type 1 diabetes, their family quality of life, and the child's health outcomes. The main questions it aims to answer are: * Primary Aim 1: Evaluate the recruitment capability, participant inclusion criteria, assessment selection and process, and data. * Primary Aim 2: Evaluate the participant acceptability of and interventionist fidelity to the intervention. * Secondary Aim: Evaluate families' preliminary outcomes to the REAL-Fam on family quality of life and participation, diabetes management self-efficacy, and child blood glucose stability. Researchers will compare the REAL-Fam intervention to the Attention Group to see if there are changes in family diabetes-related health routines and psychosocial aspects of managing a child's type 1 diabetes. Participants will: * Children will wear continuous glucose monitors for study period * Caregiver participants will complete baseline and post-intervention surveys * Intervention Group: engage in 12 audio/video telehealth sessions with REAL-Fam intervention * Attention Group: engage in 3 audio/video Zoom meetings without specialized services * Complete a post-study interview

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 99
Healthy Volunteers: t
View:

• Caregiver over 19 years old and designated guardian or parent to a child living with Type 1 Diabetes;

• Live in a rural area over 1 hour from pediatric endocrinology care team;

• Access to reliable internet

Locations
United States
North Carolina
The University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2026-06
Participants
Target number of participants: 16
Treatments
Experimental: REAL-Fam Intervention Group
8 caregiver-child dyads will receive the Resilient, Empowered, Active Living for Families intervention. This is an occupational therapy family coaching intervention, which will be delivered via 12 weekly telehealth sessions.
No_intervention: Attention Group
8 caregiver-child dyads will receive 3 attention group sessions with a research team member and engage in activities such as creating music play lists, playing games, and having conversation without specialized healthcare services.
Related Therapeutic Areas
Sponsors
Collaborators: University of Southern California, DexCom, Inc., Creighton University, American Occupational Therapy Foundation
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov