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Completed

NCT Number: NCT04777864

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.

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Key information

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Decision aid

Behavioral

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.

Primary outcomes

  1. Decisional Regret

    Time frame: 3 months after initial clinic visit

    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.

  2. Change in Quality of Choice Made

    Time frame: 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),

    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.

  3. Decision Self-Efficacy

    Time frame: Baseline: Within 1 week prior to the index clinic visit (i.e., first visit after enrolled in the study)

    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."

  4. Patient-Parent-Provider Engagement

    Time frame: Post-Index Visit: Within 24 hours after the index visit (typically occurs 1-2 weeks after enrollment),

    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.

Secondary outcomes

  1. Change in Adolescent Physical Activity

    Time frame: 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

    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.

  2. Change in Adolescent Psychosocial Functioning

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 2, 2021
Registry last updated
Sep 4, 2025

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.

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