NCT04279587TerminatedNot Applicable
Camp Based Multi-component Intervention for Families of Young Children With Type 1 Diabetes
University of Texas Southwestern Medical Center4 sites in 1 country3 target enrollmentStarted: August 19, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 3
- Locations
- 4
- Primary Endpoint
- Change in Hemoglobin A1c
Study Overview
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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in Hemoglobin A1c
Time Frame: 3 months
3 month marker of glycemic control
Secondary Outcomes
- Change in Hypoglycemia Fear Survey(3 months)
- Change in PedsQL Family Impact Module(3 months)
- Change in PedsQL Pediatric Quality of Life Inventory(3 months)
- Change in Behavioral Pediatrics Feeding Assessment(3 months)
Investigators
Olga Gupta
Professor
University of Texas Southwestern Medical Center
Study Sites (4)
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