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Behavioral Intervention

SPACE Intervention for Type 1 Diabetes (SPACE Trial)

N/A

Waitlist Available

Led By Christine A March, MD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receive daily oversight from the school nurse for their diabetes

Be younger than 18 years old

Must not have

Child is completely independent in diabetes care in school

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 4

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new care model called SPACE for children with type 1 diabetes in schools. SPACE is based on a model used to treat mental health conditions in teenagers and adults. The trial aims

Who is the study for?

This trial is for children with Type 1 Diabetes. It's designed to test a new care model called SPACE, which involves schools in managing diabetes. To join, kids must have Type 1 Diabetes and be attending school where the program will take place.

What is being tested?

The trial is testing the SPACE intervention against enhanced usual care for managing Type 1 Diabetes in children at school. Researchers want to see if SPACE is doable and helpful in this setting.

What are the potential side effects?

Since this trial focuses on a care model rather than medication, traditional side effects are not expected. However, there may be impacts on daily routines or stress levels due to changes in diabetes management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I get daily help from a school nurse for my diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child manages their diabetes on their own at school.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of Intervention Measure (FIM)

Secondary study objectives

Acceptability of Intervention Measure (AIM)

Intervention Appropriateness Measure (IAM)

Intervention Usability Scale (IUS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SPACE InterventionExperimental Treatment1 Intervention

The intervention consists of four monthly virtual visits between the school nurse, diabetes care and education specialist (DCES), parent, and any other school-related supports identified by the parent (e.g., coaches, counselors, social workers). At the first visit, the parent and child, school nurse, and DCES will discuss and determine a shared treatment plan. This will include a diabetes medical management plan and shared treatment goals for the child. At each virtual visit, the DCES and school nurse will co-lead the group through review of the shared treatment plan, a review of glucose records and insulin dosing for diabetes management, provide counseling/education, and identify any needed internal (academic) or external (health-related) supports or referrals. Families will be encouraged to set new treatment goals if any milestones are met.

Group II: ControlActive Control1 Intervention

In addition to usual care (clinical and in school), parents of children enrolled in the control group will receive four monthly phone calls from the DCES to review diabetes management, mirroring the timing of the virtual visits of the intervention group. This study will employ a wait list control.

0 / 2Eligibility criteria met