Behavioral intervention for parents to help manage children's type 1 diabetes
Improving Self-management in Childhood Diabetes - Feasibility and Preliminary Effects of a CBT-based Intervention for Parents
This study is testing a new program for parents of kids with type 1 diabetes to see if it helps them work better with their children on managing their diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06599840 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and preliminary effects of a behavioral intervention designed for parents of children aged 9-14 with type 1 diabetes. The intervention aims to enhance parent-child cooperation and improve diabetes self-management routines through six weekly group sessions and a follow-up booster session. Parents will learn and implement new behavioral strategies to support their child's diabetes management in everyday life. The study will assess participant satisfaction, attendance, and the preliminary effects of the intervention using digital questionnaires.
Who should consider this trial
Good fit: Ideal candidates are parents of children aged 9-14 with type 1 diabetes who experience difficulties in managing daily self-management routines.
Not a fit: Parents of children who do not face challenges in diabetes self-management or those with severe psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve diabetes self-management and glycemic control in children with type 1 diabetes.
How similar studies have performed: Other studies have shown promising results with behavioral interventions aimed at improving family dynamics in chronic disease management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Stockholm
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Brjánn Ljótsson, Professor — Karolinska Institute, Department of Clinical Neuroscience, Division of Psychology
- Study coordinator: Elsa Håkansson, PhD student
- Email: elsa.hakansson@ki.se
- Phone: 0046702658386
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.