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

Activo, no reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El estudio clínico NCT06599840 es un ensayo intervencionista para Diabetes mellitus tipo 1, Relaciones padre-hijo, Autogestión, Behavioral Intervention. Su estado actual es: activo, no reclutando. El ensayo se inició el 20 de septiembre de 2024, con el objetivo de reclutar a 17 participantes. Dirigido por el Instituto Karolinska, se espera que finalice el 1 de noviembre de 2025. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de agosto de 2025.
Resumen
This study investigates feasibility and preliminary effects of a new behavioral parent intervention that aims to support and improve pediatric diabetes self-management
Descripción detallada
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.

Título oficial

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

Condiciones médicas
Diabetes mellitus tipo 1Relaciones padre-hijoAutogestiónBehavioral Intervention
Otros ID del ensayo
  • Dnr2021-01558_feasibility
Número del NCT
NCT06599840
Inicio del ensayo (real)
2024-09-20
Última actualización
2025-08-27
Fecha de finalización (estimada)
2025-11-01
Inscripción (prevista)
17
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Activo, no reclutando
Palabras clave
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
Objetivo principal
Tratamiento
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Etiqueta abierta)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
OtrosIntervention group
CBT-based parent intervention consisting of 7 group sessions.
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.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Diabetes Treatment Satisfaction Questionnaire - parent report
This is a 14 item questionnaire that aim to measure parental satisfaction with the diabetes treatment. Parents are asked to rate their satisfaction on a likert scale from 0 = very unsatisfied, to 6 = very satisfied about a range of diabetes treatment domains. The questionnaire is based on the adult version of DTSQ and adapted to pediatric type 1 diabetes. Translated to Swedish and validated in a Swedish cohort.
From baseline until 26 weeks.
Diabetes Treatment Satisfaction Questionnaire - parent report
This is a 14 item questionnaire that aim to measure parental satisfaction with the diabetes treatment. Parents are asked to rate their satisfaction on a likert scale from 0 = very unsatisfied, to 6 = very satisfied about a range of diabetes treatment domains. The questionnaire is based on the adult version of DTSQ and adapted to pediatric type 1 diabetes. Translated to Swedish and validated in a Swedish cohort.
From baseline until 15 weeks.
Diabetes Treatment Satisfaction Questionnaire - parent report
This is a 14 item questionnaire that aim to measure parental satisfaction with the diabetes treatment. Parents are asked to rate their satisfaction on a likert scale from 0 = very unsatisfied, to 6 = very satisfied about a range of diabetes treatment domains. The questionnaire is based on the adult version of DTSQ and adapted to pediatric type 1 diabetes. Translated to Swedish and validated in a Swedish cohort.
Weekly from baseline to 14 weeks
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Glycaemic control
HbA1c values taken during diabetes clinic visits, registered in the national diabetes registry.
From baseline until 26 weeks.
DISABKIDS (child QoL) - parent report
This is a questionnaire that aims to measure health related quality of life in children living with chronic conditions. The parent version comprises 37 items concerning aspects of how the condition may affect the child in every-day-life, such as whether the child is worried about his/her future, if he/she spends time with friends. It is scored using five ordinal response categories ranging from "never" to "always." The negative oriented items are coded 4 ("never") to 0 ("always") whereas the positive oriented questions are inverted, so that higher score indicates higher quality of life.
From baseline until 26 weeks.
Days of physical activity
Number of day per week of physical activity. Information taken during diabetes clinic visits, and registered in the national diabetes registry.
From baseline until 26 weeks.
PedsQL - Family Impact Measure (parent QoL)
This instrument measures quality of life for parents who have children with a chronic disorder. It includes 36 items concerning physical, emotional, social and cognitive functions as well as daily activities, family relations, communication and family worry. Items are answered on a five-grade scale from 0 = never a problem, to 4 = almost always a problem. These result for each item is transformed so that 0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0, and the sum score is divided by the number of items, so that higher score indicates higher quality of life.
From baseline until 26 weeks.
Me As Parent
This is a 16-item measure that aim to measure aspects of parenting self-regulation, representing the degree to which participants perceive themselves as efficacious and competent in their role as parents. The scale includes 16 items covering the four subdomains of self-efficacy, personal agency, self-sufficiency and self-management. Items are rated on a scale from 1 = strongly disagree, to 5 = strongly agree.
From baseline until 26 weeks.
Getting Self-Management Routines Done
This 2-item questionnaire is developed by the research group and aims to serve as a parent-reported proxy for the two key self-management behaviors: taking insulin and handling high and low blood glucose values. In percentages from 0-100%, parents are asked to estimate to what extent their child 1) takes insulin and 2) handles high and low blood glucose values, in relation to all the times these behaviors are required.
From baseline until 26 weeks.
Parental Challenges in Diabetes Self-Management
This questionnaire is developed by this research group and based on common diabetes-specific themes of parental, behavioral challenges reported by parents in an interview study conducted by the group. In 12 items, parents are asked to rate how often they experience a set of challenges on a Likert scale from 0 = never, to 4 = always. These items cover four domains 1) parent worry and frustration, 2) talking, asking and reminding 3) child resistance to self-management routines, 4) child resistance to communication about self-management. This is a pilot use of the questionnaire, testing the items before deciding on future validation and psychometric evaluation. We will also use it to look at participants responses over time at a qualitative, clinical and explorative level and to investigate how the domains relate to eachother, to glycemic control and how/if responses change over time.
From baseline until 26 weeks.
General Anxiety Disorder -7
This 7-item version of the GAD questionnaire is a short measure of symptoms of anxiety. Participants are asked how often they have been bothered by a set of anxiety symptoms the last 2 weeks ranging from 0=not at all, to 7=daily. The measure will serve as a control variable in mediation analyses.
From baseline until 26 weeks.
Diabetes Family Conflict Scale - parent
This 15-item questionnaire targets family conflicts about diabetes self-management tasks. Parents are asked how often they argue with their children about a range of different self-management routines on a scale from 0=never, 1=sometimes and 2=almost always. The sum score is multiplied by 50 giving a maximum score of 100. The last update of the English version from 2023 was translated into Swedish by this research team in 2024.
From baseline until 26 weeks.
Perceived Stress Scale 10
This is the 10 item version of the standardized measurement of stress, the PSS-10. Participants are asked how often they have experienced a set of stress symptoms during the last month, ranging from 0=never to 4=very often.
From baseline until 26 weeks.
Parenting Practices Scale
Parents answer six questions about parenting practices over the last two weeks. Items are rated on a seven point Likert scale from 'Never' (coded as 1) to 'Many times a day' (coded 7), resulting in a range of 6-42 with higher scores indicating greater use of parenting skills.
From baseline until 26 weeks.
Time in Target (TiT)
TiT is the percentage of time that blood glucose levels have been within the target interval 4-8 mmol/l during the last 2 weeks. This data will be taken from the national diabetes registry (NDR), and via the Glooko online glucose system.
From baseline until 26 weeks.
Mean glucose level
The mean glucose level during the past 2 weeks. This data will be taken from the national diabetes registry (NDR), and gathered via the Glooko online glucose system.
From baseline until 26 weeks.
Blood glucose variation
Standard deviation of blood glucose levels during the past 2 weeks. This data will be taken from the national diabetes registry (NDR), and gathered via the Glooko online glucose system.
From baseline until 26 weeks.
Time with low blood glucose
Percentage of time during the past two weeks when blood glucose values have reached below 3 mmol/l. This data will be gathered via the Glooko online glucose system.
From baseline until 26 weeks.
Ketoacidosis
Number of incidents of ketoacidosis as registered in the national diabetes registry.
From baseline until 26 weeks.
Severe hypoglycemia
Number of incidents of hypoglycemia as registered in National Diabetes Registry.
From baseline until 26 weeks.
Visits at the diabetes clinic
Number of visits registered at the National Diabetes Registry.
From baseline until 26 weeks.
Client Satisfaction Questionnaire - 8
CSQ is a cross-treatment questionnaire that aims to measure patient-reported satisfaction with the treatment they have received. This version of the CSQ includes 8 items that ask participants to rate their satisfaction on a 4-point scale where higher scores indicates higher satisfaction.
15 weeks after baseline
DISABKIDS (child QoL) generic + diabetes module - child report
This is a 37 item questionnaire that aims to measure health related quality of life in children living with chronic conditions. Added to this questionnaire is the diabetes module with 10 diabetes-specific items. Questions concern aspects of how often the condition affects different aspects of every-day-life, such as whether the child feels lonely due to his/her condition, or if he/she is bothered by the medical treatment. It is scored using five ordinal response categories ranging from "never" to "always." The negative oriented items are coded 4 ("never") to 0 ("always") whereas the positive oriented questions are inverted, so that higher score indicates higher health related quality of life.
From baseline until 15 weeks.
Diabetes Family Conflict Scale - youth report
This 15-item questionnaire targets family conflicts about diabetes self-management tasks. Children/adolescents are asked how often they argue with their parents about a range of different self-management routines on a scale from 0=never, 1=sometimes and 2=almost always. The sum score is multiplied by 50 giving a maximum score of 100, with a higher score indicating more conflicts. The last update of the English version from 2023 was translated into Swedish by this research team in 2024.
From baseline until 15 weeks.
Time with high blood glucose
Percentage of time the past 2 weeks when blood glucose levels have reached above 13.9 mmol/l. This data will be gathered via the Glooko online glucose system.
From baseline until 15 weeks.
Glycaemic control
HbA1c values taken during diabetes clinic visits, registered in the national diabetes registry.
From baseline until 15 weeks.
Days of physical activity
Number of day per week of physical activity. Information taken during diabetes clinic visits, and registered in the national diabetes registry.
From baseline until 15 weeks.
DISABKIDS (child QoL) - parent report
This is a questionnaire that aims to measure health related quality of life in children living with chronic conditions. The parent version comprises 37 items concerning aspects of how the condition may affect the child in every-day-life, such as whether the child is worried about his/her future, if he/she spends time with friends. It is scored using five ordinal response categories ranging from "never" to "always." The negative oriented items are coded 4 ("never") to 0 ("always") whereas the positive oriented questions are inverted, so that higher score indicates higher quality of life.
From baseline until 15 weeks.
PedsQL - Family Impact Measure (parent QoL)
This instrument measures quality of life for parents who have children with a chronic disorder. It includes 36 items concerning physical, emotional, social and cognitive functions as well as daily activities, family relations, communication and family worry. Items are answered on a five-grade scale from 0 = never a problem, to 4 = almost always a problem. These result for each item is transformed so that 0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0, and the sum score is divided by the number of items, so that higher score indicates higher quality of life.
From baseline until 15 weeks.
Me As Parent
This is a 16-item measure that aim to measure aspects of parenting self-regulation, representing the degree to which participants perceive themselves as efficacious and competent in their role as parents. The scale includes 16 items covering the four subdomains of self-efficacy, personal agency, self-sufficiency and self-management. Items are rated on a scale from 1 = strongly disagree, to 5 = strongly agree.
From baseline until 15 weeks.
Getting Self-Management Routines Done
This 2-item questionnaire is developed by the research group and aims to serve as a parent-reported proxy for the two key self-management behaviors: taking insulin and handling high and low blood glucose values. In percentages from 0-100%, parents are asked to estimate to what extent their child 1) takes insulin and 2) handles high and low blood glucose values, in relation to all the times these behaviors are required.
From baseline until 15 weeks.
Parental Challenges in Diabetes Self-Management
This questionnaire is developed by this research group and based on common diabetes-specific themes of parental, behavioral challenges reported by parents in an interview study conducted by the group. In 12 items, parents are asked to rate how often they experience a set of challenges on a Likert scale from 0 = never, to 4 = always. These items cover four domains 1) parent worry and frustration, 2) talking, asking and reminding 3) child resistance to self-management routines, 4) child resistance to communication about self-management. This is a pilot use of the questionnaire, testing the items before deciding on future validation and psychometric evaluation. We will also use it to look at participants responses over time at a qualitative, clinical and explorative level and to investigate how the domains relate to eachother, to glycemic control and how/if responses change over time.
From baseline until 15 weeks.
General Anxiety Disorder -7
This 7-item version of the GAD questionnaire is a short measure of symptoms of anxiety. Participants are asked how often they have been bothered by a set of anxiety symptoms the last 2 weeks ranging from 0=not at all, to 7=daily. The measure will serve as a control variable in mediation analyses.
From baseline until 15 weeks.
Diabetes Family Conflict Scale - parent
This 15-item questionnaire targets family conflicts about diabetes self-management tasks. Parents are asked how often they argue with their children about a range of different self-management routines on a scale from 0=never, 1=sometimes and 2=almost always. The sum score is multiplied by 50 giving a maximum score of 100. The last update of the English version from 2023 was translated into Swedish by this research team in 2024.
From baseline until 15 weeks.
Perceived Stress Scale 10
This is the 10 item version of the standardized measurement of stress, the PSS-10. Participants are asked how often they have experienced a set of stress symptoms during the last month, ranging from 0=never to 4=very often.
From baseline until 15 weeks.
Time in Target (TiT)
TiT is the percentage of time that blood glucose levels have been within the target interval 4-8 mmol/l during the last 2 weeks. This data will be taken from the national diabetes registry (NDR), and will also be gathered repeatedly during the intervention via the Glooko online glucose system.
From baseline until 15 weeks.
Visits at the diabetes clinic
Number of visits registered at the National Diabetes Registry.
From baseline until 15 weeks.
Parenting Practices Scale
Parents answer six questions about parenting practices over the last two weeks. Items are rated on a seven point Likert scale from 'Never' (coded as 1) to 'Many times a day' (coded 7), resulting in a range of 6-42 with higher scores indicating greater use of parenting skills.
From baseline until 15 weeks.
Parental Challenges in Diabetes Self-Management
This questionnaire is developed by this research group and based on common diabetes-specific themes of parental, behavioral challenges reported by parents in an interview study conducted by the group. In 12 items, parents are asked to rate how often they experience a set of challenges on a Likert scale from 0 = never, to 4 = always. These items cover four domains 1) parent worry and frustration, 2) talking, asking and reminding 3) child resistance to self-management routines, 4) child resistance to communication about self-management. This is a pilot use of the questionnaire, testing the items before deciding on future validation and psychometric evaluation. We will also use it to look at participants responses over time at a qualitative, clinical and explorative level and to investigate how the domains relate to eachother, to glycemic control and how/if responses change over time.
Weekly from baseline to 14 weeks.
Getting Self-Management Routines Done
This 2-item questionnaire is developed by the research group and aims to serve as a parent-reported proxy for the two key self-management behaviors: taking insulin and handling high and low blood glucose values. In percentages from 0-100%, parents are asked to estimate to what extent their child 1) takes insulin and 2) handles high and low blood glucose values, in relation to all the times these behaviors are required.
Weekly from baseline to 14 weeks
Mean glucose level
The mean glucose level during the past 2 weeks. This data will be taken from the national diabetes registry (NDR), and gathered via the Glooko online glucose system.
From baseline until 15 weeks.
Blood glucose variation
Standard deviation of blood glucose levels during the past 2 weeks. This data will be taken from the national diabetes registry (NDR), and via the Glooko online glucose system.
From baseline until 15 weeks.
Time with low blood glucose
Percentage of time during the past two weeks when blood glucose values have reached below 3 mmol/l. This data will be gathered via the Glooko online glucose system.
From baseline until 15 weeks.
Ketoacidosis
Number of incidents of ketoacidosis registered in the National Diabetes Registry.
From baseline until 15 weeks.
Severe hypoglycemia
Number of incidents of hypoglycemia as registered in National Diabetes Registry.
From baseline until 15 weeks.
Short Engagement Questionnaire
This questionnaire is newly developed by the research group and is to be piloted in the current study. The length of questionnaire is adapted to individual CBT treatments depending on the number of treatment components that are presented. One week after a new behavioral strategy and an associated assignment have been presented to the participants, they are asked to rate their engagement according to the following three domains: 1. Frequency: how many days they have used the strategy (1 - 7), 2. Intensity: how much effort they have put down in using it (0 = none, to 5 = a lot). 3. Usability: how helpful they perceive the strategy to be for them (0 = not at all, to 5 = very). The total score for each of the 3 domains are divided by the number of strategies, to reach a mean score for each of the three domains. Results will be examined at a qualitative level to guide further refinement of the intervention.
Weekly from baseline until 14 weeks.
General Anxiety Disorder -7
This 7-item version of the GAD questionnaire is a short measure of symptoms of anxiety. Participants are asked how often they have been bothered by a set of anxiety symptoms the last 2 weeks ranging from 0=not at all, to 7=daily. The measure will serve as a control variable in mediation analyses.
Weekly from baseline to 14 weeks.
Time with high blood glucose
Percentage of time the past 2 weeks when blood glucose levels have reached above 13.9 mmol/l. This data will be gathered via the Glooko online glucose system.
From baseline until 26 weeks.
Time with high blood glucose (repeated measures)
Percentage of time the past 2 weeks when blood glucose levels have reached above 13.9 mmol/l. This data will be gathered via the Glooko online glucose system.
Every second week from baseline until 14 weeks.
Blood glucose variation (repeated measures)
Standard deviation of blood glucose levels during the past 2 weeks. This data will gathered via the Glooko online glucose system.
Every second week from baseline until 14 weeks.
Mean glucose level (repeated measures)
The mean glucose level during the past 2 weeks. This data will be gathered via the Glooko online glucose system.
Every second week from baseline until 14 weeks.
Time in Target (TiT) (repeated measures)
TiT is the percentage of time that blood glucose levels have been within the target interval 4-8 mmol/l during the last 2 weeks. This data will be gathered via the Glooko online glucose system.
Every second week from baseline until 14 weeks.
Time with low blood glucose (repeated measures)
Percentage of time during the past two weeks when blood glucose values have reached below 3 mmol/l. This data will be gathered via the Glooko online glucose system.
Every second week from baseline until 14 weeks.
Criterios de elegibilidad

Criterios de edad
Niño, Adulto, Adulto mayor
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
  • 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.

  • 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).
Karolinska Institutet logoInstituto Karolinska
Karolinska University Hospital logoKarolinska University Hospital
Parte responsable del ensayo
Brjann Ljotsson, Investigador principal, Professor, licensed psychologist, Karolinska Institutet
No hay datos de contacto.
1 Sitios del ensayo en 1 países
Karolinska University Hospital, Stockholm, 17164, Sweden