NCT06599840

Feasibility Study of a Behavioral Parent Intervention to Support Self-management in Pediatric Typ 1 Diabetes

Improving Self-management in Childhood Diabetes - Feasibility and Preliminary Effects of a CBT-based Intervention for Parents

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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 his/her 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.

Conditions

• Type 1 Diabetes Mellitus
• Parent-Child Relations
• Self-management
• Behavioral Intervention

Interventions

Type	Name	Description
BEHAVIORAL	Parent intervention	This is a novel intervention based on established CBT-based parenting strategies that are regularly used to strengthen parent-child cooperation and reduce conflicts. Here, the strategies are adapted to address typical challenges of T1D family life. The program structure consists of six weekly modules and a seventh booster module. Each of the first six modules has a theme with information on a parental strategy associated with the theme, self-reflective questions, and an assignment where parents plan to implement the strategy during the upcoming week. One month later, a seventh session is held to summarize the program and make plans for future progress.

Timeline

• Start date: 2024-09-20
• Primary completion: 2025-08-19
• Completion: 2025-11-01
• First posted: 2024-09-19
• Last updated: 2025-08-27

Locations

1 site across 1 country: Sweden