NCT07414303

Brief Summary

The goal of this prospective, observational study is to (1) collaborate with our stakeholders to identify essential mTBI-information from existing evidence-based materials to develop a Post-mTBI Educational Resource for children with mTBI and their parents and (2) implement our Post-mTBI Educational Resource into clinical practice to determine feasibility, acceptability, and appropriateness at Baylor Scott and White (BSW) clinical sites that treat children with mTBI.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

March 4, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

March 3, 2025

Last Update Submit

February 10, 2026

Conditions

Keywords

concussionmTBI

Outcome Measures

Primary Outcomes (3)

  • Engagement

    \# of Advisory Board members

    through study completion, an average of 3 years

  • Engagement

    \# of Engagment Partners

    through study completion, an average of 3 years

  • Engagement

    Feedback and Satisfaction on The Patient Engagement in Research Scale (PEIRS). Total scores are calculated on a scale of 0 to 100, where higher scores indicate more meaningful engagement.

    through study completion, an average of 3 years

Study Arms (1)

Advisory Board (AB)

Our target AB of stakeholders include children and young adults who are student athletes and have experienced mTBI, parents, coaches, and professional stakeholders (e.g., athletic trainers, school nurses, school administrators, physicians, healthcare administrators, local and national entities, community partners)

Other: Post-mTBI Educational Resource

Interventions

Activate clinicians and clinic administrators at BSW clinical sites that treat children with mTBI to implement the Post-mTBI Educational Resource.

Advisory Board (AB)

Eligibility Criteria

Age8 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Potential stakeholders will be between the ages of 8 and 99 years.

You may qualify if:

  • children and young adults who are student athletes
  • they have experienced a mTBI
  • parents, coaches, and professional stakeholders (e.g., athletic trainers, school nurses, school administrators, physicians, healthcare administrators, local and national entities, community partners).
  • Stakeholders were part of our previous Engagement Award.

You may not qualify if:

  • Individuals younger than 8 years old
  • Anyone who does not meet the above criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

BSW Primary Care at The Star

Frisco, Texas, 75034, United States

Location

BSW Sports Concussion Program

Frisco, Texas, 75034, United States

Location

McLane Children's Hospital at BSW Temple Medical Center

Temple, Texas, 76502, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2025

First Posted

February 17, 2026

Study Start

March 4, 2025

Primary Completion

December 8, 2025

Study Completion

December 8, 2025

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations