Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06014879
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2023-08-16
Brief Title:
EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Strengths-Based Multi-Level Behavioral Intervention to Promote Resilience and Self-Management in Youth With Type 1 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-04
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:
EMPoWER
Brief Summary:
The EMPoWER Study randomized clinical trial is a strengths-based behavioral intervention delivered to youth with type 1 diabetes age 10 to 13 and their parents The purpose of the intervention is to improve glycemic behavioral and psychosocial outcomes in youth with diabetes using a multiple systems approach that engages youth their parents and diabetes care providers to identify and build youths diabetes strengths The primary aim of this study is to assess the intervention impact on glycemic control adherence and health-related quality of life HRQOL Secondary aims are to evaluate behavioral mediators of intervention impact and to examine intervention dose as a mediator of intervention impact
In preparation for the randomized clinical trial of a new behavioral intervention for preteens with type 1 diabetes and their parents the study is first enrolling adolescents with type 1 diabetes to create videos about living well with type 1 diabetes The videos will be used in the intervention materials for the randomized clinical trial
In preparation for the randomized clinical trial of a new behavioral intervention for preteens with type 1 diabetes and their parents the study is first enrolling adolescents with type 1 diabetes to create videos about living well with type 1 diabetes The videos will be used in the intervention materials for the randomized clinical trial
Detailed Description:
The goal of the randomized clinical trial RCT is to learn if a brief behavioral intervention targeting multiple systems Type 1 Doing Well Program can improve glycemic behavioral and psychosocial outcomes in youth with type 1 diabetes Youth age 10 to 13 will enroll with one parent or legal guardian to participate in the study with them Researchers will compare the Type 1 Doing Well T1DW Program arm to the Enhanced Usual Care EUC Diabetes-Related Information and Resources Program arm
Parent-youth dyads in both study arms will provide data eg questionnaires A1c medical chart and diabetes device data at four timepoints throughout the duration of the study Following baseline data collection parent-youth dyads will complete an orientation session with study team members to be randomized to their study arm and review study activities Parent and youth will also be invited to complete a feedback interview on their experience with the program they received
The intervention will take place during the 6-month intervention period and participants will be randomly allocated to 1 of two intervention conditions
1 Parents and youth in the T1DW Program condition intervention will use a web-based mobile application to do daily and weekly activities focused on recognizing and reinforcing youths diabetes strengths They will also have a conversation with the youths diabetes provider about what is going well in diabetes care at a routine diabetes appointment
2 Parents and youth in the EUC Program condition will receive and review 6 monthly diabetes-related information and resources in the form of electronic handouts
Diabetes care providers at each of the sites will also be enrolled in the study Provider participants will receive a brief training to deliver the strength-based conversation with parent-youth dyads in the T1DW Program arm and they will complete study-related questionnaires about their experiences delivering the strengths-based conversation component of the intervention
Parent-youth dyads in both study arms will provide data eg questionnaires A1c medical chart and diabetes device data at four timepoints throughout the duration of the study Following baseline data collection parent-youth dyads will complete an orientation session with study team members to be randomized to their study arm and review study activities Parent and youth will also be invited to complete a feedback interview on their experience with the program they received
The intervention will take place during the 6-month intervention period and participants will be randomly allocated to 1 of two intervention conditions
1 Parents and youth in the T1DW Program condition intervention will use a web-based mobile application to do daily and weekly activities focused on recognizing and reinforcing youths diabetes strengths They will also have a conversation with the youths diabetes provider about what is going well in diabetes care at a routine diabetes appointment
2 Parents and youth in the EUC Program condition will receive and review 6 monthly diabetes-related information and resources in the form of electronic handouts
Diabetes care providers at each of the sites will also be enrolled in the study Provider participants will receive a brief training to deliver the strength-based conversation with parent-youth dyads in the T1DW Program arm and they will complete study-related questionnaires about their experiences delivering the strengths-based conversation component of the intervention
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