Camp Based Multi-component Intervention for Families of Young Children

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04279587
Study type	Interventional
Source	University of Texas Southwestern Medical Center
Contact	Perrin C White, MD
Phone	2146486875
Email	perrin.white@utsouthwestern.edu
Status	Not yet recruiting
Phase	N/A
Start date	April 15, 2024
Completion date	December 15, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Camp Based Multi-component Intervention for Families of Young Children With Type 1 Diabetes

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms