N/A
N=110
Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians
Concussion, Brain
Bottom Line
View on ClinicalTrials.gov: NCT04777864 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Decisional Regret — 1.68; 2.00; 1.80; 1.77 Score on a scale — p=0.18
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Decision Aid (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 11+ yrs
- Sex
- All
- Sponsor
- Seattle Children's Hospital
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decisional Regret |
1.68; 2.00; 1.80; 1.77 | 0.18 |
| PRIMARY Change in Quality of Choice Made |
43.81; 42.62; 20.91; 20.95; 15.00; 13.81 | 0.975 |
| PRIMARY Decision Self-Efficacy |
80.41; 77.29; 77.91; 79.90 | — |
| PRIMARY Patient-Parent-Provider Engagement |
2.83; 2.76; 2.68; 3.07; 2.94; 2.87 | — |
| SECONDARY Change in Adolescent Physical Activity |
466; 1220.79; 2141.39; 1775.11 | 0.03 sig |
| SECONDARY Change in Adolescent Psychosocial Functioning |
81.14; 79.52; 84.05; 83.81; 84.05; 83.81 | 0.76 |
Summary
Investigators will conduct a pilot efficacy test of a decision aid about contact sport participation post-concussion.
Eligibility Criteria
Participants in the clinical trial component of this study will be adolescents, parents, and healthcare providers:
Adolescent Inclusion Criteria:
- Age 11-17
- Sustained at least 1 concussion and is scheduled for a concussion injury visit
Parent Inclusion Criteria:
- Age 18 or older
- Parent of a child between the age of 11 and 17 (inclusive) who has sustained at least 1 concussion and is scheduled for a concussion injury visit
Healthcare Provider Inclusion Criteria:
- Age 18 or older
- Seattle Children's affiliated healthcare provider who provides patient care to youth with concussion
Data sourced from ClinicalTrials.gov (NCT04777864). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.