School Partnered Collaborative Care (SPACE) Intervention for Children With Type 1 Diabetes

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT06420661
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • SPACE for T1D — BEHAVIORAL
    school-partnered collaborative care model
  • Enhanced usual care — BEHAVIORAL
    routine diabetes care with optional monthly insulin dose adjustment

Study Details

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.

Key Dates

Start date
Aug 21, 2024
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: SPACE 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.
  • Active Comparator: Control
    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.

Primary Outcome Measure

Feasibility of Intervention Measure (FIM) [ Time Frame: Month 4 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15237-

Find similar trials in Pittsburgh, PA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Pittsburgh· Pittsburgh, PA

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