Pilot Study: Intensive Education in a Residential Camp Setting for Families of Young Children With Type 1 Diabetes — TotCamp  

Type 1 Diabetes Mellitus Clinical Trial

Official title: Pilot Study: Intensive Education in a Residential Camp Setting for Families of Young Children With Type 1 Diabetes

Status Completed

Clinical Trial Summary

18 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. A second 'booster' session, will be conducted 6 months later.

Clinical Trial Description

We propose to deliver a structured multidisciplinary family-centered intervention over a 3-day weekend, with a second similar "booster" session 6 months later. The intervention will be based at our regional diabetes camp, Camp Sweeney. 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.

We 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 after each of the two camp sessions, is improvement in Hemoglobin A1c (HbA1c). This outcome will be compared with that of historical controls.

Exploratory Hypotheses:

Compared with pretreatment baseline and historical controls, subjects attending two 3-day sessions at a family diabetes camp will improve:

• HbA1c 3 months after the first camp session

• Hypoglycemia frequency, as measured by continuous glucose monitoring

• Medical system utilization, as measured by telephone call frequency and also by emergency room visits and hospitalizations

• 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.

• Diabetes knowledge, assessed by questionnaire

• Development of friendships between subject families, assessed by questionnaire ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

• NCT number: NCT02432586
• Study type: Interventional
• Source: University of Texas Southwestern Medical Center
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Completion date: January 2017