Type1diabetesNCT04279587
Camp Based Multi-component Intervention for Families of Young Children With Type 1 Diabetes
A study testing Residential camp in people with Type1diabetes, run by University of Texas Southwestern Medical Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Residential camp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Aug 2019to 13 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Perrin C White
Dallas, Texas, 75230
Children's Medical Center
Dallas, Texas, 75235
About this study
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.
Read the 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.
- Conditions
- Type1diabetes
- Being tested
- Residential camp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Residential campBehavioural
Intensive education at a residential camp.
| Study group | Role | What they receive |
|---|---|---|
| Residential camp participant | Experimental | Participants will attend a 3 day family-centered, multidisciplinary, intensive education session at a regional camp. Receives: Behavioral: Residential camp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c
3 month marker of glycemic control
Measured: 3 months
Secondary outcomes (4)
Change in PedsQL Family Impact Module
Survey measure of impact the child's chronic disease has on the family
Measured: 3 months
Change in PedsQL Pediatric Quality of Life Inventory
Survey measure of quality of life
Measured: 3 months
Change in Hypoglycemia Fear Survey
Survey measure of hypoglycemia fear
Measured: 3 months
Change in Behavioral Pediatrics Feeding Assessment
Survey measure of child feeding habits
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start19 Aug 2019
- Primary completion13 Feb 2023
- Study completion13 Feb 2023
Why it stopped: Study terminated due to COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Gupta, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279587
- Sponsor's protocol ID
- 2018-0282
- Status last verified
- Aug 2024
- First submitted
- 19 Feb 2020
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camp Based Multi-component Intervention for Families of Young Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04279587
- Acronym / sponsor ID
- 2018-0282
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to COVID-19 pandemic
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 13 Feb 2023 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Residential camp participant | Experimental | Behavioral: Residential campParticipants will attend a 3 day family-centered, multidisciplinary, intensive education session at a regional camp. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Residential campIntensive education at a residential camp. | Behavioural | Residential camp participant |
Primary outcome
Change in Hemoglobin A1c
Time frame: 3 months
3 month marker of glycemic control
4 secondary outcomes
Change in PedsQL Family Impact Module
Time frame: 3 months
Change in PedsQL Pediatric Quality of Life Inventory
Time frame: 3 months
Change in Hypoglycemia Fear Survey
Time frame: 3 months
Change in Behavioral Pediatrics Feeding Assessment
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Study terminated due to COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Residential camp in people with Type1diabetes, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1c (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.