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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04279587
• Other study ID #: 2018-0282
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: December 15, 2025

Study information

• Verified date: October 2023
• Source: University of Texas Southwestern Medical Center
• Contact: Perrin C White, MD
• Phone: 2146486875
• Email: perrin.white[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: December 15, 2025
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

Behavioral:
• Residential camp
Intensive education at a residential camp.

Locations

Country	Name	City	State
United States	Children's Medical Center	Dallas	Texas
United States	Perrin C White	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1c	3 month marker of glycemic control	3 months
Secondary	Change in PedsQL Family Impact Module	Survey measure of impact the child's chronic disease has on the family	3 months
Secondary	Change in PedsQL Pediatric Quality of Life Inventory	Survey measure of quality of life	3 months
Secondary	Change in Hypoglycemia Fear Survey	Survey measure of hypoglycemia fear	3 months
Secondary	Change in Behavioral Pediatrics Feeding Assessment	Survey measure of child feeding habits	3 months