Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599840
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Feasibility Study of a Behavioral Parent Intervention to Support Self-management in Pediatric Typ 1 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Improving Self-management in Childhood Diabetes - Feasibility and Preliminary Effects of a CBT-based Intervention for Parents
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study investigates feasibility and preliminary effects of a new behavioral parent intervention that aims to support and improve pediatric diabetes self-management
Detailed Description:
Diabetes self-management is extensive complex and places high demands on the affected individual and hisher family Today half of Swedish children and adolescents with type 1 diabetes T1D do not reach target levels of glycemic control Among the various factors that influence glycemic control family function is of great importance Parent-child conflicts surrounding self-management tasks have been shown to predict glycemic control deterioration over time This study will explore feasibility and preliminary effects of a new behavioral parent intervention that aims to strengthen parent-child cooperation and facilitate diabetes routines in every-day-life The results of the feasibility study will guide further refinement of the intervention and the design of a future RCT
Through digital ads and posters at the diabetes clinics in Stockholm we will recruit parents of children aged 9-14 with T1D experiencing problems in getting diabetes self-management routines to work in every-day-life The intervention is held at the hospital and includes six weekly group sessions and a booster session one month later At the end of each session parents plan to use a new behavioral strategy at home during the upcoming week This feasibility study will explore participant satisfaction and attendance combined with qualitative assessments of their experiences Preliminary effects are investigated through repeated assessments of a set of digitalized questionnaires data from the national diabetes registry and online blood glucose data during the intervention phase post intervention and at 3- months follow up
This intervention is believed to be an effective way to target and prevent T1D self-management problems and may come to serve as an important complement to standard diabetes treatment
Through digital ads and posters at the diabetes clinics in Stockholm we will recruit parents of children aged 9-14 with T1D experiencing problems in getting diabetes self-management routines to work in every-day-life The intervention is held at the hospital and includes six weekly group sessions and a booster session one month later At the end of each session parents plan to use a new behavioral strategy at home during the upcoming week This feasibility study will explore participant satisfaction and attendance combined with qualitative assessments of their experiences Preliminary effects are investigated through repeated assessments of a set of digitalized questionnaires data from the national diabetes registry and online blood glucose data during the intervention phase post intervention and at 3- months follow up
This intervention is believed to be an effective way to target and prevent T1D self-management problems and may come to serve as an important complement to standard diabetes treatment
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