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

Karolinska Institute

Status

Active, not recruiting

Conditions

Type 1 Diabetes Mellitus

Self-management

Parent-Child Relations

Behavioral Intervention

Treatments

Behavioral: Parent intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06599840

Dnr2021-01558_feasibility

Details and patient eligibility

About

This study investigates feasibility and preliminary effects of a new behavioral parent intervention that aims to support and improve pediatric diabetes self-management

Full 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.

Enrollment

17 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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).