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

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.

Study Overview

• Status: Terminated
• Conditions: Type1diabetes
• Intervention / Treatment: Behavioral: Residential camp

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Medical Center
    • Dallas, Texas, United States, 75230
      • Perrin C White

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 3-5.5 years old (+/- 2 months) at the date of camp session they are eligible to join.
• Child and Parents fluent in English
• Type 1 diabetes mellitus diagnosed for at least 10 months previous to date of first camp they are eligible to join.
• Taking insulin
• Custodial parent or guardian (preferable both parents or guardians) willing to attend both session of camp and the activities scheduled for them.
• Parent or guardian must sign consent before any study procedures are performed.

Exclusion Criteria:

• Neonatal diabetes (diagnosis in the first 3 months of life) or documented Monogenic Diabetes of Youth; i.e., a likely genetic form of diabetes rather than an autoimmune etiology.
• Post-surgical diabetes (e.g., pancreatectomy for congenital hyperinsulinism). Such patients often cannot secrete glucagon, leading to a particularly severe inability to defend against hypoglycemia.
• Other severe chronic disease (e.g., cancer, cystic fibrosis) which in the judgment of the investigator is likely to significantly affect glycemic control.
• Patients cannot be taking systemic corticosteroids at enrollment because of adverse effects on glycemic control, but the investigators will not disqualify subjects who require such therapy during the study. Inhaled or topical corticosteroids are permissible.
• Patients with hypothyroidism or hyperthyroidism must be clinically euthyroid and have free T4 and thyroid stimulating hormone within age-appropriate reference ranges at last medically indicated testing. Patients with out of range values may be retested after medication dose adjustment.
• Developmental delay or behavioral disorder in the patient of sufficient severity, in the judgment of the investigator, to interfere with group activities.
• Medical or psychiatric disorder in a parent of sufficient severity, in the judgment of the investigator, to interfere with group activities.
• Celiac disease is not an exclusion criterion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Residential camp participant; Participants will attend a 3 day family-centered, multidisciplinary, intensive education session at a regional camp.	Behavioral: Residential camp; Intensive education at a residential camp.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin A1c	3 month marker of glycemic control	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PedsQL Family Impact Module	Survey measure of impact the child's chronic disease has on the family	3 months
Change in PedsQL Pediatric Quality of Life Inventory	Survey measure of quality of life	3 months
Change in Hypoglycemia Fear Survey	Survey measure of hypoglycemia fear	3 months
Change in Behavioral Pediatrics Feeding Assessment	Survey measure of child feeding habits	3 months

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2019
• Primary Completion (Actual): February 13, 2023
• Study Completion (Actual): February 13, 2023

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2018-0282

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No