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

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

Study Overview

• Status: Completed
• Conditions: Concussion, Brain
• Intervention / Treatment: Behavioral: Decision Aid

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: Decision Aid; Usual care, plus introduction of a decision aid	Behavioral: Decision Aid; In addition to usual care, participants (parents and adolescents) receive the newly developed decision aid prior to their clinic visit(s). Clinicians receive a summary to review and use to help facilitate the decision making process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional Regret	We used the 5-item Decisional Regret Scale to measure personal perceptions of regret when considering the decision previously made about sports participation post-concussion. Responses are on a 5-point Likert scale, from (1) strongly agree to (5) strongly disagree. Two positively worded items were reverse scored. Responses were averaged to create a decisional regret score with a possible range of 1 to 5, with higher scores indicating greater regret.	3 months after initial clinic visit
Change in Quality of Choice Made	We used the 10-item Decisional Conflict Scale-Low Literacy version to measure parent and adolescent perceptions of certainty in making the decision to return to sports after concussion recovery. Respondents answered 10 items using a 3-point scale scored as 0 = "yes," 2 = "unsure," and 4 = "no." Item scores were summed, divided by 10, and then multiplied by 25 to produce a total decisional conflict score ranging from 0 to 100, with higher scores indicating greater decisional conflict and lower decision certainty.	Baseline: Within 1 week prior to the index clinic visit (i.e., the participant's first visit after they enrolled in the study), Post-Index Visit: Within 24 hours after the index visit (typically occurs 1-2 weeks after enrollment),
Decision Self-Efficacy	We used a 12-item Decision Self-Efficacy Scale to measure parent and adolescent confidence in making health-related decisions. Participants responded using a 5-point scale scored from 0 = "not at all confident" to 4 = "very confident." Item scores were summed, divided by 12, and then multiplied by 25 to produce a total decision self-efficacy score ranging from 0 to 100, with higher scores indicating greater confidence in decision-making. The scale included an additional item: "Let my child/my parent(s) know what I think is best for them/me."	Baseline: Within 1 week prior to the index clinic visit (i.e., first visit after enrolled in the study)
Patient-Parent-Provider Engagement	We used the 19-item Decision Making Involvement Scale to assess engagement and perceived support in the decision making process, divided into two subscales: Within Family Engagement and Family-Provider Engagement. Participants rated their agreement with items on a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). Subscale scores are calculated by averaging the item responses within each subscale. Each subscale score ranges from 1 to 4, with higher scores indicating more engagement or involvement.	Post-Index Visit: Within 24 hours after the index visit (typically occurs 1-2 weeks after enrollment),

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Adolescent Physical Activity	We used the International Physical Activity Questionnaire (IPAQ-SF) to assess adolescent physical activity post-concussion. Participants reported the number of days and minutes spent on vigorous, moderate, and walking activities. These values were converted to MET-minutes per week (MMW) using standard MET values (vigorous = 8, moderate = 4, walking = 3.3). The total physical activity score was calculated by summing the MMW for all activities.	Baseline: Within 1 week prior to the index clinic visit (i.e., first visit after enrolled in the study), Post-Index Visit: Within 24 hours after the index visit (typically occurs 1-2 weeks after enrollment), 3 months after initial clinic visit
Change in Adolescent Psychosocial Functioning	We used the Pediatric Quality of Life Inventory, Psychosocial subscale (PEDS-QL) to measure adolescent emotional functioning. Participants rated items on a 5-point Likert scale, with higher scores reflecting better emotional functioning. To ensure ease of interpretation, items were reverse scored and then transformed to a 0-100 scale, where higher scores indicate better emotional health.	Baseline: Within 1 week prior to the index clinic visit (i.e., first visit after enrolled in the study), Post-Index Visit: Within 24 hours after the index visit (typically occurs 1-2 weeks after enrollment), 3 months after initial clinic visit.

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Concussion; Investigative Techniques; Decision Support Techniques
• Other Study ID Numbers: STUDY00002334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No