Concussion, BrainNCT04777864

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

A study testing Decision Aid in people with Concussion, Brain, run by Seattle Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 11 years and olderHealthy volunteers can take part
Conditions the study is for: Concussion, Brain
What is being tested?: Decision Aid
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteUnited States
Study dates: 30 Aug 2021to 1 Apr 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 11 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

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 locations and contacts

1 site in 1 country.

United States1 site

Seattle Children's Hospital
Seattle, Washington, 98105

Other trials in United States

About this study

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

Read the 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.

Conditions: Concussion, Brain
Being tested: Decision Aid
Medical subject headings: Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Decision AidBehavioural
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.

Study groups in NCT04777864
Study group	Role	What they receive
Usual Care	No intervention	Not described
Decision Aid	Experimental	Usual care, plus introduction of a decision aid Receives: Behavioral: Decision Aid

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 20211 Apr 2024

First posted2 Mar 2021
Study start30 Aug 2021
Primary completion1 Apr 2024
Study completion1 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Concussion, BrainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04777864
Sponsor's protocol ID: STUDY00002334
Status last verified: Aug 2025
First submitted: 23 Feb 2021
Last updated: 4 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Concussion, Brain trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians
ClinicalTrials.gov ID: NCT04777864
Acronym / sponsor ID: STUDY00002334
Conditions: Concussion, Brain
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Seattle Children's HospitalUniversity, hospital or other
Study start: 30 Aug 2021 (actual)
Primary completion: 1 Apr 2024 (actual)
Study completion: 1 Apr 2024 (actual)
First posted: 2 Mar 2021 (actual)
Results: Posted 4 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Usual Care	No intervention	–
Decision Aid	Experimental	Behavioral: Decision AidUsual care, plus introduction of a decision aid

Who may qualify

Ages: 11 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Decision AidIn 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.	Behavioural	Decision Aid

Primary outcome

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.
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.
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."
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.

2 secondary outcomes

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
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.

Results and safety

Results posted to the registry on 4 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	48	40
Decision Aid	62	43

Primary outcome: Decisional Regret

Time frame: 3 months after initial clinic visit. Mean (Standard Deviation). Unit: Score on a scale

Measure	Usual Care n = 41	Decision Aid n = 36
Parents	1.68 (0.64)	2.00 (0.83)
Adolescents	1.80 (1.09)	1.77 (0.69)

Usual Care vs Decision Aid: p = 0.18, t-test, 2 sided
Usual Care vs Decision Aid: p = 0.91, t-test, 2 sided

Population analysed: The number analyzed in one or more rows differs from the overall number analyzed because only participants who completed the scale at 3-month follow-up survey were included in the analyses. Outcomes are also reported separately by subgroup (parent, child).

Primary outcome: 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),. Mean (Standard Deviation). Unit: Score on a scale

Measure	Usual Care n = 44	Decision Aid n = 42
Parent: Baseline	43.81 (18.43)	42.62 (21.83)
Adolescent: Baseline	20.91 (21.02)	20.95 (26.06)
Parent: Post-Index Visit	15.00 (19.31)	13.81 (16.87)
Adolescent: Post-Index Visit	7.62 (18.07)	7.75 (13.81)

Usual Care vs Decision Aid: p = 0.975, Regression, Linear
Usual Care vs Decision Aid: p = 0.854, Regression, Linear

Population analysed: The number analyzed in one or more rows differs from the overall number because results are reported separately by group (Parent, Child) and timepoint (Baseline, Post-Index Visit). The number reported for each timepoint includes only those participants who responded at that timepoint and, for the Post-Index Visit timepoint, also reported that they made a decision.

Primary outcome: Decision Self-Efficacy

Time frame: Baseline: Within 1 week prior to the index clinic visit (i.e., first visit after enrolled in the study). Mean (Standard Deviation). Unit: score on a scale

Measure	Usual Care n = 40	Decision Aid n = 40
Parent	80.41 (15.09)	77.29 (17.62)
Adolescent	77.91 (14.01)	79.90 (17.17)

Population analysed: The number analyzed in one or more rows differs from the overall number because results are reported separately by group (Parent, Adolescent).

Primary outcome: Patient-Parent-Provider Engagement

Time frame: Post-Index Visit: Within 24 hours after the index visit (typically occurs 1-2 weeks after enrollment),. Mean (Standard Deviation). Unit: score on a scale

Measure	Usual Care n = 22	Decision Aid n = 20
Parent: Within family engagement	2.83 (0.60)	2.76 (0.55)
Adolescent: Within family engagement	2.68 (0.84)	3.07 (0.49)
Parent: Family-clinician engagement	2.94 (0.43)	2.87 (0.55)
Adolescent: Family-clinician engagement	3.20 (0.36)	3.25 (0.39)

Population analysed: Analyses only include participants who reported that they made a decision after their first visit. Outcomes are reported separately by subgroup (parent, child) and subscale (within family engagement and family-clinician engagement).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care - Parents	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Decision Aid - Parents	0 of 21 (0%)	0 of 21 (0%)	0 of 21
Usual Care - Adolescents	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Decision Aid - Adolescents	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Concussion, Brain

RecruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Decision Aid in people with Concussion, Brain, run by Seattle Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decisional Regret (time frame: 3 months after initial clinic visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04777864.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.