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

Type1diabetes Clinical Trial

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

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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

• 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