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

NCT04279587 | Terminated

• 1 other identifier: 2018-0282
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c

  3 month marker of glycemic control

  3 months

Secondary Outcomes (4)

• Change in PedsQL Family Impact Module

  3 months

• Change in PedsQL Pediatric Quality of Life Inventory

  3 months

• Change in Hypoglycemia Fear Survey

  3 months

• Change in Behavioral Pediatrics Feeding Assessment

  3 months

Study Arms (1)

Residential camp participant

EXPERIMENTAL

Participants will attend a 3 day family-centered, multidisciplinary, intensive education session at a regional camp.

Behavioral: Residential camp

Interventions

Residential camp BEHAVIORAL

Intensive education at a residential camp.

Residential camp participant

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

Perrin C White

Dallas, Texas, 75230, United States

Location

Children's Medical Center

Dallas, Texas, 75235, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: August 19, 2019
• Primary Completion: February 13, 2023
• Study Completion: February 13, 2023
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

US (2)