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

NCT06599840 | Active Not Recruiting

• 1 other identifier: Dnr2021-01558_feasibility
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (50)

• Glycaemic control

  From baseline until 26 weeks.

• DISABKIDS (child QoL) - parent report

  From baseline until 26 weeks.

• Days of physical activity

  From baseline until 26 weeks.

• PedsQL - Family Impact Measure (parent QoL)

  From baseline until 26 weeks.

• Me As Parent

  From baseline until 26 weeks.

Study Arms (1)

Intervention group

OTHER

CBT-based parent intervention consisting of 7 group sessions.

Behavioral: Parent intervention

Interventions

Parent intervention 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.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17164, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Brjánn Ljótsson, Professor

  Karolinska Institute, Department of Clinical Neuroscience, Division of Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, licensed psychologist

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: September 20, 2024
• Primary Completion: August 19, 2025
• Study Completion: November 1, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)