School Partnered Collaborative Care (SPACE) Intervention for Children With Type 1 Diabetes
SPACE
2 other identifiers
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2024
CompletedFirst Posted
Study publicly available on registry
May 20, 2024
CompletedStudy Start
First participant enrolled
August 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
February 9, 2026
February 1, 2026
1.8 years
May 14, 2024
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of Intervention Measure (FIM)
The primary outcome is feasibility, defined as the extent to which the intervention can be successfully carried out in the school setting. Feasibility will be measured by the FIM, a 4-item scale with an ordinal scoring system from strongly disagree to strongly agree. The scale scores can range from 1-5 with higher scores indicating higher feasibility. The FIM will be completed by the participating child's parent and school nurse. The school nurses will be asked to complete the measure for each iteration of SPACE, which will mean that the same nurse may complete the measure multiple times. Nurses will need to complete the measure within 14 days of the end of that iteration of SPACE, allowing us to descriptively assess change in an individual school nurse's response over time. The intervention will be deemed "feasible" if the mean overall score is \>4/5 (80%).
Month 4
Secondary Outcomes (3)
Acceptability of Intervention Measure (AIM)
Month 4
Intervention Appropriateness Measure (IAM)
Month 4
Intervention Usability Scale (IUS)
Month 4
Study Arms (2)
SPACE Intervention
EXPERIMENTALThe 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.
Control
ACTIVE COMPARATORIn 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.
Interventions
routine diabetes care with optional monthly insulin dose adjustment
Eligibility Criteria
You may qualify if:
- Diagnosis of type 1 diabetes for at least 6 months
- Attend school in one of the partnered school districts
- Receive daily oversight from the school nurse for their diabetes
- Managed by the Children's Hospital of Pittsburgh Diabetes center
- Able to participate in English
You may not qualify if:
- Child has developmental delay or neuropsychiatric disorder which would preclude their participation in their diabetes care and/or completion of study questionnaires
- Child is completely independent in diabetes care in school
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15237, United States
Related Publications (1)
March CA, Rothenberger S, Naame E, Stouffer V, Moon C, Lyon AR, Libman I, Miller E. School-partnered collaborative care intervention for young children with type 1 diabetes: A pilot and feasibility protocol. Contemp Clin Trials. 2026 Apr;163:108259. doi: 10.1016/j.cct.2026.108259. Epub 2026 Feb 16.
PMID: 41707755DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine A March, MD
Univeristy of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
May 14, 2024
First Posted
May 20, 2024
Study Start
August 21, 2024
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
April 30, 2027
Last Updated
February 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share