Trials / Terminated
TerminatedNCT04279587
Camp Based Multi-component Intervention for Families of Young Children With Type 1 Diabetes
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- University of Texas Southwestern Medical Center · Academic / Other
- Sex
- All
- Age
- 3 Years – 5 Years
- Healthy volunteers
- Not accepted
Summary
Eighteen preschool aged children and their families will attend structured, multidisciplinary, family-centered intensive education sessions over a 3-day weekend in a residential camp setting to address the unique challenges of managing type 1 diabetes mellitus in young children.
Detailed description
The invesigators propose to deliver a structured multidisciplinary family-centered intervention over a 3-day weekend. The intervention will be based at a regional camp. The proposed camp encounters aim to provide: * An opportunity for intensive education beyond that achievable in a single class, and without the unfavorable impacts of multiple weekday classes on family and work time. * Varied educational modalities including didactic sessions, practical demonstrations and role playing. * Close observation of each child throughout the day and night by experienced diabetes counselors and medical staff to identify and help correct maladaptive family behaviors. * A safe environment where parents can participate in group therapy sessions without child care worries. * An opportunity for age-appropriate child-centered educational and therapeutic activities. * An opportunity for families to form mutually-supportive friendships. * Fun weekends away where the parents have help caring for their diabetic children. The investigators will conduct this pilot study, which will enroll 18 preschool children age 3-5.5 years, with the goal of obtaining preliminary results for 15 subjects. The primary outcome, to be determined approximately one month before and 3 months after the camp session, is improvement in Hemoglobin A1c (HbA1c). Exploratory Hypotheses: Compared with pretreatment baseline, subjects attending a 3-day session at a family diabetes camp will improve: * HbA1c 3 months after the first camp session * Behavioral/QoL assessments, including the parents of young children version of the hypoglycemia fear survey (HFS-P-YC), the Behavioral Pediatrics Feeding Assessment Scale (BPFAS), and the general and diabetes modules of the PedsQL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Residential camp | Intensive education at a residential camp. |
Timeline
- Start date
- 2019-08-19
- Primary completion
- 2023-02-13
- Completion
- 2023-02-13
- First posted
- 2020-02-21
- Last updated
- 2024-08-26
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04279587. Inclusion in this directory is not an endorsement.