REAL-Fam Feasibility Study for Youth Diabetes Management

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

Conditions

• Type 1 Diabetes

Interventions

BEHAVIORAL

REAL-Fam Occupational Therapy Family Coaching

The REAL-Fam draws on the expertise of occupational therapy in evaluating the fit between the demands of everyday activities and the skills and abilities of the parent-child dyads. The dyad and the occupational therapist will be equipped to co-develop personalized strategies to enable participation in these meaningful occupations. It facilitates the family's consistent, habitual, and effective performance of their child's diabetes management tasks into their personalized daily routines. Emphasis is on the creation or modification of family-centered diabetes management and routines and catered to the child's developmental needs. Due to the complexity of diabetes management cares and the child's age, the caregiver will be present for all sessions. When working towards a caregiver-centered outcome, the caregiver will participate with little child involvement. When working toward a child-centered outcome, the child will be the focus of that session.

Sponsors & Collaborators

• American Occupational Therapy Foundation

  collaborator OTHER

• Creighton University

  collaborator OTHER

• DexCom, Inc.

  collaborator INDUSTRY

• University of Southern California

  collaborator OTHER

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Vanessa Jewell, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-12-15

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• United States

Study Locations