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Enrolling by Invitation

NCT Number: NCT06420661

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15237, United States

About this study

This pilot cluster randomized controlled trial will examine the feasibility of a school-partnered collaborative care (SPACE) model for children with type 1 diabetes (SPACE for T1D). School districts will be randomized to the intervention or control arm in a 2:1 allocation ratio. School districts randomized to the control arm in Year 1 of the study will be invited to participate in SPACE in Year 2. All children with type 1 diabetes meeting inclusion criteria in each school district will be approached to participate through their school nurse.

All research activities will be conducted using a virtual video-conferencing platform. The intervention arm will consist of four monthly virtual meetings between the child, school nurse, diabetes care and education specialist (DCES), and any other identified school-related support people. The purpose of these meetings will be to determine a shared treatment plan, make treatment recommendations, and determine progress towards meeting the child's goals. The control arm will receive usual care in the school and the clinical setting as well as monthly phone calls from the DCES to the parent to offer review of blood glucoses. No additional contact with the school will be offered.

Participants and their parents will be asked to complete surveys regarding their overall health and well-being and provide us access to their glucometer/continuous glucose monitor data. Additional information will be collected from the electronic health record (hemoglobin A1c, care utilization, referrals). At the end of study, surveys for the parent and school nurse will assess feasibility and other implementation outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

SPACE for T1D

Behavioral

school-partnered collaborative care model

Enhanced Usual Care

Behavioral

routine diabetes care with optional monthly insulin dose adjustment

Primary outcomes

  1. Feasibility of Intervention Measure (FIM)

    Time frame: Month 4

    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%).

Secondary outcomes

  1. Acceptability of Intervention Measure (AIM)

    Time frame: Month 4

    Acceptability is defined as the perception that the intervention is agreeable or satisfactory. Acceptability will be measured with AIM, 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 acceptability. The AIM 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 "acceptable" if the mean overall score is >4/5 (80%).

  2. Intervention Appropriateness Measure (IAM)

    Time frame: Month 4

    Appropriateness is defined as the perceived fit or relevance of the intervention to the school setting. Appropriateness will be measured with the IAM, 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 appropriateness. The IAM 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 "appropriate" if the mean overall score is >4/5 (80%).

  3. Intervention Usability Scale (IUS)

    Time frame: Month 4

    Usability is defined as the degree to which the intervention is able to be used. Usability will be measured by the IUS, a 10-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 usability. The IUS 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 "usable" if the mean overall score is >4/5 (80%).

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

School Partnered Collaborative Care (SPACE) for Pediatric Type 1 Diabetes: A Pilot Feasibility Trial

Acronym: SPACE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 20, 2024
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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