Ignite Creation Date:
2024-05-06 @ 2:17 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04279587
Status:
TERMINATED
Last Update Posted:
2023-10-18
First Post:
2020-02-19
Brief Title:
Camp Based Multi-component Intervention for Families of Young Children With Type 1 Diabetes
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Camp Based Multi-component Intervention for Families of Young Children With Type 1 Diabetes
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to COVID-19 pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 3-55 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
BehavioralQoL 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
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 3-55 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
BehavioralQoL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None