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

NCT04777864 | Completed Results

• 1 other identifier: STUDY00002334
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Concussion, Brain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Change in Adolescent Physical Activity

  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

  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.

Study Arms (2)

Usual Care

NO INTERVENTION

Decision Aid

EXPERIMENTAL

Usual care, plus introduction of a decision aid

Behavioral: Decision Aid

Interventions

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.

Decision Aid

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 11-17
• Sustained at least 1 concussion and is scheduled for a concussion injury visit
• 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
• Age 18 or older
• Seattle Children's affiliated healthcare provider who provides patient care to youth with concussion

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Dr. Emily Kroshus
• Organization: Seattle Children's Research Institute

Emily.Kroshus@seattlechildrens.org

206-884-5326

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 2, 2021
• Study Start: August 30, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)