Actively Recruiting
Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis - Aims 2 and 3
Led by University of Utah · Updated on 2025-12-05
110
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new decision support tool designed to help children with neuromuscular scoliosis (NMS), their parents, and healthcare providers during surgical treatment decisions. This pilot trial aims to assess the tool's impact on treatment decisions, decision quality, and the emotional, cognitive, and behavioral effects on families. The trial will also explore the tool's feasibility, acceptability, and potential barriers to its use, informing the design of a future larger effectiveness study. Participants in this study will either receive usual care or have access to the novel decision support tool during their clinic visits. The tool incorporates elements to improve shared decision making by addressing treatment uncertainties and aligning decisions with family preferences and values. Pediatric orthopedic surgeons and neurosurgeons involved in treating NMS will also participate to provide feedback on the tool's implementation. During the study, researchers will assess participants immediately after their clinic visits on various outcomes, including treatment intentions, decision conflict, knowledge, trust in physicians, risk perception, and readiness to decide. Qualitative assessments of acceptability, feasibility, and appropriateness will occur within three months for parents and at study end for providers. The study runs from October 2025 through March 2027 and includes multiple questionnaires and interviews to gather comprehensive feedback on the decision support tool.
CONDITIONS
Brief Title
Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent-child pairs where the child has neuromuscular scoliosis
- Child is between 8 and 21 years old
- Families speak English or Spanish
- Child is consulting for possible surgery for neuromuscular scoliosis
- Pediatric orthopedic surgeons and neurosurgeons treating neuromuscular scoliosis at study sites
You will not qualify if you...
- Child is younger than 8 years at orthopedic consultation
- Child has Duchenne's or Becker's muscular dystrophy due to different treatment considerations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 18 months
Participants experience usual care or use a novel decision support tool during clinic visits to assist in shared decision making for treatment options related to neuromuscular scoliosis.
Clinic visits occurring at baseline and follow-up as part of usual care and study assessments
Trial Site Locations
Total: 2 locations
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
University of Utah
Salt Lake City, Utah, United States, 84114
Actively Recruiting
Research Team
A
Angela Zhu, BS
M
Michelle Wilcox
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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