REAL-Fam Feasibility Study for Youth Diabetes Management

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT07212790
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • REAL-Fam Occupational Therapy Family Coaching — BEHAVIORAL
    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.

Study Details

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

Key Dates

Start date
Dec 15, 2025
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Percentage of Families Consented Versus Approached [ Time Frame: 12-week post treatment initiation ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of North Carolina at Chapel HillChapel HillNorth Carolina27514
Vanessa Jewell, PhD
[email protected]
919-843-4463
Shelley Newpher, MA
[email protected]
Vanessa Jewell, PhD (PRINCIPAL_INVESTIGATOR)
Julia Shin, EdD (SUB_INVESTIGATOR)
Amy Thompson, MS (SUB_INVESTIGATOR)
Nina Jain, MD (SUB_INVESTIGATOR)
Sabrina Zadrozny, PhD (SUB_INVESTIGATOR)
Emily Knezevich, PharmD (SUB_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
The University of North Carolina at Chapel Hill· Chapel Hill, NC

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