The Impact of Changing to a New Child- and Family-centered Outpatient Diabetes Clinic Focusing on Early Involvement of the Child With Diabetes, Training in Calmness Around Diabetes Management, Healthy Lifestyle, and Creating Peer-to-peer Networks (StenoChild)

Steno Diabetes Centers

Status: Invitation-only

Conditions: Diabetes; Quality of Life; Children

Treatments: Behavioral: Group consultations and peer-to-peer learning; Other: Standard Care (in control arm)

Study type: Interventional

Funder types: Other

Identifiers

NCT07377266

p-2024-17600 (Other Identifier)

H-25016032

Details and patient eligibility

About

The goal of StenoChild is to strengthen the treatment of children under 10 years old with diabetes through a multi-component approach. This includes play-based methods, a focus on nutrition and mental health, and peer-to-peer programs that facilitate parental support and learning. The project has both a clinical and organizational dimension, as it aims to improve diabetes care and change practices and task organization at Steno Diabetes Center Copenhagen, SDCC.

Full description

The investigators encourage families to engage in eating, exercising, playing, and storytelling together, leveraging children's natural inclination to learn through play. This approach allows healthcare providers (HCPs) and parents to gain insights into the child's perspective, improving communication.

The hypotheses are i) improved calmness during diabetes-related tasks with potential painful procedures such as shift of insulin infusions set and sensor will ease diabetes management and reduce parental distress; ii) improved structure and calmness around meals will ease diabetes management, reflected in interaction with insulin pumps; iii) the group and play-based approach will lead to healthier lifestyle changes compared to usual care.

Enrollment: 100 estimated patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion of children and their families

Inclusion Criteria:

• Age 3-10 years
• Followed at Steno Diabetes Center Copenhagen

Exclusion Criteria:

• Severe psychiatric disease
• Language barriers (Children not speaking Danish, Parents not speaking Danish or English)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

StenoChild intervention

Experimental group

Description:

See below, Families are randomized pragmatically based on their assigned HCP. Approximately 50% will attend a new clinic offering group-based, family-centered care (90-100 families); the rest receive standard care, with the intervention offered later in a waitlist design.

Treatment:

Behavioral: Group consultations and peer-to-peer learning

Standard Care

Placebo Comparator group

Description:

Families are randomized pragmatically based on their assigned HCP. Approximately 50% will attend a new clinic offering group-based, family-centered care (90-100 families); the rest receive standard care, with the intervention offered later in a waitlist design.

Treatment:

Other: Standard Care (in control arm)