Trial Summary
What is the purpose of this trial?
This is a pilot trial of a school-partnered collaborative care (SPACE) model for pediatric type 1 diabetes. The trial will investigate the feasibility and acceptability of SPACE for children with type 1 diabetes in the school setting. SPACE is adapted from a collaborative care model used to treat depression and other mental health care conditions in adolescents and adults.
Research Team
CA
Christine A March, MD
Principal Investigator
Univeristy of Pittsburgh
Eligibility Criteria
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.Inclusion Criteria
I have been diagnosed with type 1 diabetes for over 6 months.
Managed by the Children's Hospital of Pittsburgh Diabetes center
I get daily help from a school nurse for my diabetes.
See 2 more
Exclusion Criteria
My child manages their diabetes on their own at school.
Child has developmental delay or neuropsychiatric disorder which would preclude their participation in their diabetes care and/or completion of study questionnaires
Treatment Details
Interventions
- SPACE for T1D (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
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.
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Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
Trials
1,820
Recruited
16,360,000+
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Trials
2,513
Recruited
4,366,000+