Ignite Creation Date:
2024-05-06 @ 7:25 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02527525
Status:
COMPLETED
Last Update Posted:
2021-08-06
First Post:
2015-08-16
Brief Title:
First STEPS- Study of Type 1 in Early Childhood and Parenting Support
Sponsor:
Childrens National Research Institute
Organization:
Childrens National Research Institute
Study Overview
Official Title:
A Stepped Care Behavioral Intervention Trial for Young Children With T1D
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The incidence of type 1 diabetes T1D in young children age 6 years is rising Disease management guidelines offered by the ADA and other diabetes care organizations place a high burden of responsibility onto these childrens parents and caregivers to check blood sugar administer insulin and monitor diet and physical activity to maintain tight glycemic control Unfortunately this occurs at a vulnerable time in life when childrens behavior is unpredictable their T1D is difficult to control parenting stress is elevated and caregivers are strained by normal child caretaking routines T1D education and support tends to be highly concentrated at diagnosisduring the inpatient stay and requires rapid knowledge and skill acquisition on the part of parents Not all families respond equally well to this teaching model and many need more guided practice problem-solving assistance and behavioral supports than can be offered in a one-size-fits-all patient education approach Our research will attempt to better meet the needs of individual families through a clinical behavioral stepped care intervention for T1D in parents of young children by using real-time glycemic control and parental depression indices to intensify management support when indicated Primary caregivers of young children 6 years newly diagnosed with T1D will be randomized to either a 3-step stepped care treatment or usual care comparison condition Stepped care components include T1D management support delivered by trained lay parent consultants Step 1 T1D parenting strategies and mealtime behavior management delivered by bachelors level behavioral assistants Step 2 and individualized diabetes educationmanagement planning with a certified diabetes nurse educator and consultation with a diabetes team clinical psychologist Step 3 Biomedical and psychosocial measurements including A1c depressive symptoms mealtime behavior parenting stress quality of life will occur at baseline and 3-month intervals for up to 15 months post-diagnosis The results of this work will ultimately lead to a more practical approach to T1D education and management that can be translated more easily into a variety of clinical practice settings to support young childrens T1D management
Detailed Description:
Research Design and Methods Overview of Study Design Procedure The aim of this randomized controlled trial RCT is to determine the efficacy of a stepped care intervention that provides participants with up to 3 intensity levels or steps of clinical behavioral intervention support to help manage young childrens newly diagnosed type 1 diabetes T1D compared to usual care We expect that children of families allocated to the intervention condition First STEPS will have better glycemic outcomes better parent psychosocial functioning and fewer behavior problems including negative mealtime behaviors A total of 200 parents will be randomly allocated in a 31 ratio to be treated with either First STEPS n150 or usual care n50 COMPARISON condition all participants receive standard diabetes education as part of usual care in both conditions Our intervention is intended to be delivered by trained peer parent coaches Step 1 bachelors or masters prepared research educators Step 2 and RN or masters level certified diabetes educators and PhD level clinical psychologist Step 3
For Step 1 we are employing the use of parent coaches as a low-cost highly translatable intervention that parents in our pilot study reported to be extremely helpful following the time of diagnosis For Step 2 the research educators will build upon support provided by parent coaches and will implement our 5 telephone session behavioral intervention that provides cognitive behavioral strategies to support parents in their daily management of T1D while at the same time targets parental mood and specifically symptoms of depression Step 3 engages certified diabetes educators and the diabetes team clinical psychologist and allows for more intensive review of the childs medical regimen and targets potential changes The clinical psychologist consultation addresses how symptoms of parental depression may interfere with caring for the childs diabetes and will refer for further treatment if needed Intervention content training and fidelity for each intervention step are described below Participants are evaluated at baseline at diagnosis pre-random allocation and follow-up 3- 6- 9- 12- and 15-months post-diagnosis These steps are sequentially designed to systematically build expertise and intensity
Participants 200 self-identified primary caregivers for children ages 1-6 newly diagnosed with T1D 50 female will be enrolled at 2 trial sites in 1 Washington DC Childrens National Medical Center CNMC and 2 Houston Texas Texas Childrens Hospital TCH T1D affects approximately 1 in 500 children and although its incidence is increasing numbers of available children for study are still much lower than for other illnesses including type 2 diabetes The investigators have therefore decided to have 2 sites for adequate power for this study Although the investigators anticipate that the majority 90 of primary caregivers will be female eg mothers grandmothers males who self-identify as the primary caregiver eg fathers will also be included
For Step 1 we are employing the use of parent coaches as a low-cost highly translatable intervention that parents in our pilot study reported to be extremely helpful following the time of diagnosis For Step 2 the research educators will build upon support provided by parent coaches and will implement our 5 telephone session behavioral intervention that provides cognitive behavioral strategies to support parents in their daily management of T1D while at the same time targets parental mood and specifically symptoms of depression Step 3 engages certified diabetes educators and the diabetes team clinical psychologist and allows for more intensive review of the childs medical regimen and targets potential changes The clinical psychologist consultation addresses how symptoms of parental depression may interfere with caring for the childs diabetes and will refer for further treatment if needed Intervention content training and fidelity for each intervention step are described below Participants are evaluated at baseline at diagnosis pre-random allocation and follow-up 3- 6- 9- 12- and 15-months post-diagnosis These steps are sequentially designed to systematically build expertise and intensity
Participants 200 self-identified primary caregivers for children ages 1-6 newly diagnosed with T1D 50 female will be enrolled at 2 trial sites in 1 Washington DC Childrens National Medical Center CNMC and 2 Houston Texas Texas Childrens Hospital TCH T1D affects approximately 1 in 500 children and although its incidence is increasing numbers of available children for study are still much lower than for other illnesses including type 2 diabetes The investigators have therefore decided to have 2 sites for adequate power for this study Although the investigators anticipate that the majority 90 of primary caregivers will be female eg mothers grandmothers males who self-identify as the primary caregiver eg fathers will also be included
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DK102561-01A1 | NIH | None | httpsreporternihgovquickSearch1R01DK102561-01A1 |