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

Primary Purpose

Type1diabetes

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Residential camp

About this trial

This is an interventional supportive care trial for Type1diabetes

Eligibility Criteria

3 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Perrin C White
Children's Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Residential camp participant

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Hemoglobin A1c

3 month marker of glycemic control

Secondary Outcome Measures

Change in PedsQL Family Impact Module

Survey measure of impact the child's chronic disease has on the family

Change in PedsQL Pediatric Quality of Life Inventory

Survey measure of quality of life

Change in Hypoglycemia Fear Survey

Survey measure of hypoglycemia fear

Change in Behavioral Pediatrics Feeding Assessment

Survey measure of child feeding habits

Full Information

NCT ID

NCT04279587

First Posted

February 19, 2020

Last Updated

October 16, 2023

Sponsor

University of Texas Southwestern Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04279587

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 15, 2024 (Anticipated)

Primary Completion Date

April 15, 2025 (Anticipated)

Study Completion Date

December 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type1diabetes

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Residential camp participant

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Residential camp

Intervention Description

Intensive education at a residential camp.

Primary Outcome Measure Information:

Title

Change in Hemoglobin A1c

Description

3 month marker of glycemic control

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Change in PedsQL Family Impact Module

Description

Survey measure of impact the child's chronic disease has on the family

Time Frame

3 months

Title

Change in PedsQL Pediatric Quality of Life Inventory

Description

Survey measure of quality of life

Time Frame

3 months

Title

Change in Hypoglycemia Fear Survey

Description

Survey measure of hypoglycemia fear

Time Frame

3 months

Title

Change in Behavioral Pediatrics Feeding Assessment

Description

Survey measure of child feeding habits

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Perrin C White, MD

Phone

2146486875

perrin.white@utsouthwestern.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Yasmin Dominguez

Phone

(214) 456-5362

Facility Information:

Facility Name

Perrin C White

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Children's Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

12. IPD Sharing Statement

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

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