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

NCT ID: NCT06599840

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2025-11-01

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

CBT-based parent intervention consisting of 7 group sessions.

Group Type: OTHER

Parent intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Parents/guardians of children aged 9-14 with type 1 diabetes.
• The child has had type 1 diabetes for at least one year.
• The parent experience difficulties in managing daily life and/or the parent-child collaboration around self-management routines.
• The perceived difficulties should not solely be due to perceived problems in the medical aspects of the diabetes treatment, such as a perceived need for more support in insulin dosing, more diabetes education, or technical/medical support. This criterion is based solely on the subjective judgement of the parent him-/herself.
• The child receives diabetes care at one of the three diabetes clinics in the Stockholm Region.
• The parent speaks, understands, and can read Swedish.
• The parent claims to be motivated and has the practical possibility to participate in the study and attend group meetings.

Exclusion Criteria

• The parent reports current and severe psychiatric conditions in themselves or the child that need to be prioritized, such as severe depression, suicidal thoughts/self-harm, psychosis, or mania.
• The parent is involved in another psychological treatment of a behavior-changing nature that is in an active phase, either concerning themselves or a child.
• Major planned changes in diabetes treatment that require learning and behavioral changes, such as transitioning from pen to pump, and that are expected to occur during the first 3.5 months of the study (active intervention phase).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Brjann Ljotsson

Professor, licensed psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brjánn Ljótsson, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institute, Department of Clinical Neuroscience, Division of Psychology

Locations

Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Dnr2021-01558_feasibility

Identifier Type: -

Identifier Source: org_study_id