Pilot Study: Intensive Education in a Residential Camp Setting for Families of Young Children With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

Detailed 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
    

Intervention name(s): Intensive Education
Intervention type(s): Behavioral
Intervention description(s): Participants will attend a 3 day family-centered, multidisciplinary, intensive education session at our regional diabetes camp, Camp Sweeney. A second 'booster' session will be conducted 6 months later.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: T1DM; Diabetes; Child; Toddler