Skip to main content
OpenTrials
Completed

NCT Number: NCT04635475

Return to Learn Implementation Bundle for Schools (RISE) After Youth Concussion

Using the Consolidated Framework for Implementation Research, as our overarching conceptual framework, this translational 2 ½ year pragmatic RCT uses a clustered, stepped wedge design to test the effectiveness of a school-based (unit of analysis) implementation strategy (project intervention) called RISE (Return to Learn Implementation bundle for schools) on evidence-based practice (RTL protocol implementation; main outcome) and student outcomes (i.e., days to RTL start after diagnosis) after youth concussion. The central hypothesis is that schools in the intervention condition receiving the RISE implementation bundle (toolkit plus school support) will have more complete and sustainable RTL protocols, and better student outcomes compared to schools in control condition who receive only written RTL protocol information. As rural and low SES schools are particularly likely to struggle to implement RTL protocols,19,25 we specifically examine RISE implementation and barriers to implementation related to school demographic characteristics related to health equity. The school characteristics we examine are rurality, primary language, racial and ethnic mix, and free/reduced-cost lunch.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Concussion, Mild Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HIPRC

Seattle, Washington, 98122, United States

About this study

As you are aware, COVID caused us to consider how to complete this project and answer the scientific questions posed in the Specific Aims. The investigators considered shifting the RTL project to a later time and switching with another project but this would not have worked for the other project.

To solve this challenge of impact of school changes, the investigators convened with the project advisory board for consultation, consulted the research core at HIPRC and contacted the participants who were to have been participants in the randomized controlled trial. 19 of the 24 schools responded. From this work, the investigators agreed that since the school context has changed to either home online or hybrid mode, that students with concussion who are the recipients of the intervention should not be deprived of an intervention that is potentially beneficial.

The investigators have therefore made the following adaptations that retained the specific aims and central hypothesis that school context capacity can be strengthened to provide tailored student-centered RTL care and improve outcomes for students with a concussion.

To this end, the investigators are considering "school" wherever students are receiving an education. The investigators will recruit subjects who are currently largely coordinating education due to COVID, work with their schools, and recruit nationally. These adaptations will require a sample size of a total of 150 high school students with recent concussion (75 intervention [Group A: RISE bundle + CDC information], 75 controls [Group B: CDC information only]) who will be recruited using social media and other platforms.

There are some advantages to this design: 1) The investigator's intervention materials will now be able to be translated to Spanish due to adaptations, 2) This project will reach more particpants in rural and from disadvantaged backgrounds, 3) Communications between particpants and schools will be enhanced.

Given return to school, we have reverted to the stepped wedge study design in WA state.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Public high school student, grade 9th - 12th who has sustained a concussion.

  • High School Student between the age of 14-19, who attends in person, online, or a hybrid academic platform, and the concussion did not include an acute care hospital course greater than 48 hours.

Treatment and study plan

RISE Bundle

Behavioral

Toolkit to build capacity where students receive education and provide symptom based and tailored accommodations after concussion

Primary outcomes

  1. RTL OUTCOMES - Symptom

    Time frame: 5 week

    Tracking children's symptoms over a five-week period of time. Parental completion of 4 - week symptom checklist 100% completion of weekly symptom checklist resulting in 20% fewer symptoms for the intervention group.

Secondary outcomes

  1. RTL OUTCOMES - Academic Success

    Time frame: 5 week

    Outcome measures to assess academic success. Parental completion of CLASS survey weeks 2 and 4 resulting in a 20 % less decline Intervention group.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2020
Registry last updated
Dec 10, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.