Clinical trial NCT06599840: Feasibility Study of a Behavioral Parent Intervention to Support Self-management in Pediatric Typ 1 Diabetes
Official title: Improving Self-management in Childhood Diabetes - Feasibility and Preliminary Effects of a CBT-based Intervention for Parents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Parent-Child Relations
Self-management
Behavioral Intervention
Keywords: feasibility study
type 1 diabetes
diabetes self-management
parent support
parent intervention
pediatric self-management
behavioral intervention
pediatric type 1 diabetes
self-management problems
parent training
CBT
T1D
self-management intervention
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2024-09-19
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Diabetes Treatment Satisfaction Questionnaire - parent report
timeFrame: From baseline until 26 weeks.
measure: Diabetes Treatment Satisfaction Questionnaire - parent report
timeFrame: From baseline until 15 weeks.
measure: Diabetes Treatment Satisfaction Questionnaire - parent report
timeFrame: Weekly from baseline to 14 weeks
Secondary outcomes:
measure: Glycaemic control
timeFrame: From baseline until 26 weeks.
measure: DISABKIDS (child QoL) - parent report
timeFrame: From baseline until 26 weeks.
measure: Days of physical activity
timeFrame: From baseline until 26 weeks.
measure: PedsQL - Family Impact Measure (parent QoL)
timeFrame: From baseline until 26 weeks.
measure: Me As Parent
timeFrame: From baseline until 26 weeks.
measure: Getting Self-Management Routines Done
timeFrame: From baseline until 26 weeks.
measure: Parental Challenges in Diabetes Self-Management
timeFrame: From baseline until 26 weeks.
measure: General Anxiety Disorder -7
timeFrame: From baseline until 26 weeks.
measure: Diabetes Family Conflict Scale - parent
timeFrame: From baseline until 26 weeks.
measure: Perceived Stress Scale 10
timeFrame: From baseline until 26 weeks.
measure: Parenting Practices Scale
timeFrame: From baseline until 26 weeks.
measure: Time in Target (TiT)
timeFrame: From baseline until 26 weeks.
measure: Mean glucose level
timeFrame: From baseline until 26 weeks.
measure: Blood glucose variation
timeFrame: From baseline until 26 weeks.
measure: Time with low blood glucose
timeFrame: From baseline until 26 weeks.
measure: Ketoacidosis
timeFrame: From baseline until 26 weeks.
measure: Severe hypoglycemia
timeFrame: From baseline until 26 weeks.
measure: Visits at the diabetes clinic
timeFrame: From baseline until 26 weeks.
measure: Client Satisfaction Questionnaire - 8
timeFrame: 15 weeks after baseline
measure: DISABKIDS (child QoL) generic + diabetes module - child report
timeFrame: From baseline until 15 weeks.
measure: Diabetes Family Conflict Scale - youth report
timeFrame: From baseline until 15 weeks.
measure: Time with high blood glucose
timeFrame: From baseline until 15 weeks.
measure: Glycaemic control
timeFrame: From baseline until 15 weeks.
measure: Days of physical activity
timeFrame: From baseline until 15 weeks.
measure: DISABKIDS (child QoL) - parent report
timeFrame: From baseline until 15 weeks.
measure: PedsQL - Family Impact Measure (parent QoL)
timeFrame: From baseline until 15 weeks.
measure: Me As Parent
timeFrame: From baseline until 15 weeks.
measure: Getting Self-Management Routines Done
timeFrame: From baseline until 15 weeks.
measure: Parental Challenges in Diabetes Self-Management
timeFrame: From baseline until 15 weeks.
measure: General Anxiety Disorder -7
timeFrame: From baseline until 15 weeks.
measure: Diabetes Family Conflict Scale - parent
timeFrame: From baseline until 15 weeks.
measure: Perceived Stress Scale 10
timeFrame: From baseline until 15 weeks.
measure: Time in Target (TiT)
timeFrame: From baseline until 15 weeks.
measure: Visits at the diabetes clinic
timeFrame: From baseline until 15 weeks.
measure: Parenting Practices Scale
timeFrame: From baseline until 15 weeks.
measure: Parental Challenges in Diabetes Self-Management
timeFrame: Weekly from baseline to 14 weeks.
measure: Getting Self-Management Routines Done
timeFrame: Weekly from baseline to 14 weeks
measure: Mean glucose level
timeFrame: From baseline until 15 weeks.
measure: Blood glucose variation
timeFrame: From baseline until 15 weeks.
measure: Time with low blood glucose
timeFrame: From baseline until 15 weeks.
measure: Ketoacidosis
timeFrame: From baseline until 15 weeks.
measure: Severe hypoglycemia
timeFrame: From baseline until 15 weeks.
measure: Short Engagement Questionnaire
timeFrame: Weekly from baseline until 14 weeks.
measure: General Anxiety Disorder -7
timeFrame: Weekly from baseline to 14 weeks.
measure: Time with high blood glucose
timeFrame: From baseline until 26 weeks.
measure: Time with high blood glucose (repeated measures)
timeFrame: Every second week from baseline until 14 weeks.
measure: Blood glucose variation (repeated measures)
timeFrame: Every second week from baseline until 14 weeks.
measure: Mean glucose level (repeated measures)
timeFrame: Every second week from baseline until 14 weeks.
measure: Time in Target (TiT) (repeated measures)
timeFrame: Every second week from baseline until 14 weeks.
measure: Time with low blood glucose (repeated measures)
timeFrame: Every second week from baseline until 14 weeks.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institute, Department of Clinical Neuroscience, Division of Psychology
name: Brjánn Ljótsson, Professor
role: PRINCIPAL_INVESTIGATOR
References: