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Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians

Seattle Children's Healthcare System logo

Seattle Children's Healthcare System

Status

Completed

Conditions

Concussion, Brain

Treatments

Behavioral: Decision Aid

Study type

Interventional

Funder types

Other

Identifiers

NCT04777864
STUDY00002334

Details and patient eligibility

About

Investigators will conduct a pilot efficacy test of a decision aid about contact sport participation post-concussion.

Full description

The clinical trial portion of this study will enroll 40 adolescents and their parent/caregiver who are seen in the Sports Medicine clinic with a diagnosis of concussion. 20 will receive usual care, and 20 will receive a decision aid to facilitate the decision making process about sport participation post-concussion. Adolescents and their parent/caregiver will complete separate surveys at a minimum of three timepoints: before their initial clinic visit, after each clinic visit (up until a decision regarding sports participation post-concussion is made), and three months after their first clinic visit. The study team will also conduct surveys with clinicians about their experiences with implementation.

Enrollment

110 patients

Sex

All

Ages

11+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

110 participants in 2 patient groups

Usual Care
No Intervention group
Decision Aid
Experimental group
Description:
Usual care, plus introduction of a decision aid
Treatment:
Behavioral: Decision Aid

Trial documents
3

Trial contacts and locations

1

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Central trial contact

Emily Kroshus, Principal Investigator

Data sourced from clinicaltrials.gov

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