Trial Outcomes & Findings for Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians (NCT NCT04777864)

Last Updated: 2025-09-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

110 participants

Primary outcome timeframe

3 months after initial clinic visit

Results posted on

2025-09-04

Participant Flow

We recruited a sample of adolescents (ages 11-17) and their parent/caregiver who were seen in the Sports Medicine clinic with a diagnosis of concussion. After dyads enrolled, the parent or guardian and adolescent were emailed and/or texted separate surveys to complete before the upcoming appointment.

All participants were assigned to the control or intervention condition. There were 10 dyads (n=20 participants) enrolled in the intervention that did not complete the intervention prior to their index visit. These dyads were excluded from analyses. 24 dyads (48 participants) were included in the control condition and 21 dyads (42 participants) were included in the intervention condition. The protocol enrollment number represents the number of individual participants enrolled in each condition.

Participant milestones

Participant milestones
Measure	Usual Care Participants received post-concussion care as usual.	Decision Aid Usual care, plus introduction of a decision aid 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.
Overall Study STARTED	48	62
Overall Study Index Visit	45	51
Overall Study COMPLETED	40	43
Overall Study NOT COMPLETED	8	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care Participants received post-concussion care as usual.	Decision Aid Usual care, plus introduction of a decision aid 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.
Overall Study Lost to Follow-up	8	19

Baseline Characteristics

Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 3 months after initial clinic visit

Population: 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).

Outcome measures

Outcome measures
Measure	Usual Care n=41 Participants Participants received post-concussion care as usual.	Decision Aid n=36 Participants Usual care, plus introduction of a decision aid 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.
Decisional Regret Parents	1.68 Score on a scale Standard Deviation 0.64	2.00 Score on a scale Standard Deviation 0.83
Decisional Regret Adolescents	1.80 Score on a scale Standard Deviation 1.09	1.77 Score on a scale Standard Deviation 0.69

PRIMARY outcome

Timeframe: 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),

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Usual Care n=44 Participants Participants received post-concussion care as usual.	Decision Aid n=42 Participants Usual care, plus introduction of a decision aid 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.
Change in Quality of Choice Made Parent: Baseline	43.81 Score on a scale Standard Deviation 18.43	42.62 Score on a scale Standard Deviation 21.83
Change in Quality of Choice Made Adolescent: Baseline	20.91 Score on a scale Standard Deviation 21.02	20.95 Score on a scale Standard Deviation 26.06
Change in Quality of Choice Made Parent: Post-Index Visit	15.00 Score on a scale Standard Deviation 19.31	13.81 Score on a scale Standard Deviation 16.87
Change in Quality of Choice Made Adolescent: Post-Index Visit	7.62 Score on a scale Standard Deviation 18.07	7.75 Score on a scale Standard Deviation 13.81

PRIMARY outcome

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

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

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."

Outcome measures

Outcome measures
Measure	Usual Care n=40 Participants Participants received post-concussion care as usual.	Decision Aid n=40 Participants Usual care, plus introduction of a decision aid 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.
Decision Self-Efficacy Parent	80.41 score on a scale Standard Deviation 15.09	77.29 score on a scale Standard Deviation 17.62
Decision Self-Efficacy Adolescent	77.91 score on a scale Standard Deviation 14.01	79.90 score on a scale Standard Deviation 17.17

PRIMARY outcome

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

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Usual Care n=22 Participants Participants received post-concussion care as usual.	Decision Aid n=20 Participants Usual care, plus introduction of a decision aid 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.
Patient-Parent-Provider Engagement Parent: Within family engagement	2.83 score on a scale Standard Deviation 0.60	2.76 score on a scale Standard Deviation 0.55
Patient-Parent-Provider Engagement Adolescent: Within family engagement	2.68 score on a scale Standard Deviation 0.84	3.07 score on a scale Standard Deviation 0.49
Patient-Parent-Provider Engagement Parent: Family-clinician engagement	2.94 score on a scale Standard Deviation 0.43	2.87 score on a scale Standard Deviation 0.55
Patient-Parent-Provider Engagement Adolescent: Family-clinician engagement	3.20 score on a scale Standard Deviation 0.36	3.25 score on a scale Standard Deviation 0.39

SECONDARY outcome

Timeframe: 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

Population: The number analyzed in one or more rows differs from the overall number because these analyses include only adolescent participants.

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.

Outcome measures

Outcome measures
Measure	Usual Care n=21 Participants Participants received post-concussion care as usual.	Decision Aid n=21 Participants Usual care, plus introduction of a decision aid 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.
Change in Adolescent Physical Activity Post-Index Visit	466 total mmw Standard Deviation 581.02	1220.79 total mmw Standard Deviation 1440.68
Change in Adolescent Physical Activity 3 Month Follow-up	2141.39 total mmw Standard Deviation 1111.35	1775.11 total mmw Standard Deviation 1378.90

SECONDARY outcome

Population: The number analyzed in one or more rows differs from the overall number because results are reported separately by timepoint (Baseline, Post-Index Visit, 3 Month Follow-up). The number reported for each timepoint includes only those participants who responded at that timepoint .

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.

Outcome measures

Outcome measures
Measure	Usual Care n=22 Participants Participants received post-concussion care as usual.	Decision Aid n=21 Participants Usual care, plus introduction of a decision aid 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.
Change in Adolescent Psychosocial Functioning Baseline	81.14 Score on a scale Standard Deviation 16.10	79.52 Score on a scale Standard Deviation 18.43
Change in Adolescent Psychosocial Functioning Post-Index Visit	84.05 Score on a scale Standard Deviation 14.97	83.81 Score on a scale Standard Deviation 15.56
Change in Adolescent Psychosocial Functioning 3-Month Follow-up	84.05 Score on a scale Standard Deviation 14.96	83.81 Score on a scale Standard Deviation 15.56

Adverse Events

Usual Care - Parents

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Decision Aid - Parents

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care - Adolescents

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Decision Aid - Adolescents

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Emily Kroshus

Seattle Children's Research Institute

Phone: 206-884-5326

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Usual Care n=46 Participants Participants received post-concussion care as usual.	Decision Aid n=42 Participants Usual care, plus introduction of a decision aid 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.	Total n=88 Participants Total of all reporting groups
Age, Continuous Parent	47.11 years STANDARD_DEVIATION 4.61 • n=19 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.	46.05 years STANDARD_DEVIATION 3.90 • n=21 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.	46.55 years STANDARD_DEVIATION 4.23 • n=40 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.
Age, Continuous Adolescent	15.56 years STANDARD_DEVIATION 1.40 • n=21 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.	15.59 years STANDARD_DEVIATION 1.75 • n=21 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.	15.57 years STANDARD_DEVIATION 1.55 • n=42 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.
Sex/Gender, Customized Parent · Female	14 Participants n=22 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.	19 Participants n=21 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.	33 Participants n=43 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.
Sex/Gender, Customized Parent · Male	8 Participants n=22 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.	2 Participants n=21 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.	10 Participants n=43 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.
Sex/Gender, Customized Parent · Non-binary	0 Participants n=22 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.	0 Participants n=21 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.	0 Participants n=43 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.
Sex/Gender, Customized Adolescent · Female	12 Participants n=22 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.	11 Participants n=21 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.	23 Participants n=43 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.
Sex/Gender, Customized Adolescent · Male	9 Participants n=22 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.	10 Participants n=21 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.	19 Participants n=43 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.
Sex/Gender, Customized Adolescent · Non-binary	1 Participants n=22 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.	0 Participants n=21 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.	1 Participants n=43 Participants • Data is reported only for individuals who were included in the analyses and responded to this question. Data is reported separately for parents and adolescents.
Ethnicity (NIH/OMB) Parent · Hispanic or Latino	1 Participants n=24 Participants • Data is reported separately for parents and adolescents.	1 Participants n=21 Participants • Data is reported separately for parents and adolescents.	2 Participants n=45 Participants • Data is reported separately for parents and adolescents.
Ethnicity (NIH/OMB) Parent · Not Hispanic or Latino	21 Participants n=24 Participants • Data is reported separately for parents and adolescents.	20 Participants n=21 Participants • Data is reported separately for parents and adolescents.	41 Participants n=45 Participants • Data is reported separately for parents and adolescents.
Ethnicity (NIH/OMB) Parent · Unknown or Not Reported	2 Participants n=24 Participants • Data is reported separately for parents and adolescents.	0 Participants n=21 Participants • Data is reported separately for parents and adolescents.	2 Participants n=45 Participants • Data is reported separately for parents and adolescents.
Ethnicity (NIH/OMB) Adolescent · Hispanic or Latino	1 Participants n=22 Participants • Data is reported separately for parents and adolescents.	3 Participants n=21 Participants • Data is reported separately for parents and adolescents.	4 Participants n=43 Participants • Data is reported separately for parents and adolescents.
Ethnicity (NIH/OMB) Adolescent · Not Hispanic or Latino	21 Participants n=22 Participants • Data is reported separately for parents and adolescents.	18 Participants n=21 Participants • Data is reported separately for parents and adolescents.	39 Participants n=43 Participants • Data is reported separately for parents and adolescents.
Ethnicity (NIH/OMB) Adolescent · Unknown or Not Reported	0 Participants n=22 Participants • Data is reported separately for parents and adolescents.	0 Participants n=21 Participants • Data is reported separately for parents and adolescents.	0 Participants n=43 Participants • Data is reported separately for parents and adolescents.
Race (NIH/OMB) Parent · American Indian or Alaska Native	0 Participants n=24 Participants • Data is reported separately for parents and adolescents.	0 Participants n=21 Participants • Data is reported separately for parents and adolescents.	0 Participants n=45 Participants • Data is reported separately for parents and adolescents.
Race (NIH/OMB) Parent · Asian	2 Participants n=24 Participants • Data is reported separately for parents and adolescents.	1 Participants n=21 Participants • Data is reported separately for parents and adolescents.	3 Participants n=45 Participants • Data is reported separately for parents and adolescents.
Race (NIH/OMB) Parent · Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants • Data is reported separately for parents and adolescents.	0 Participants n=21 Participants • Data is reported separately for parents and adolescents.	0 Participants n=45 Participants • Data is reported separately for parents and adolescents.
Race (NIH/OMB) Parent · Black or African American	1 Participants n=24 Participants • Data is reported separately for parents and adolescents.	0 Participants n=21 Participants • Data is reported separately for parents and adolescents.	1 Participants n=45 Participants • Data is reported separately for parents and adolescents.
Race (NIH/OMB) Parent · White	19 Participants n=24 Participants • Data is reported separately for parents and adolescents.	19 Participants n=21 Participants • Data is reported separately for parents and adolescents.	38 Participants n=45 Participants • Data is reported separately for parents and adolescents.
Race (NIH/OMB) Parent · More than one race	0 Participants n=24 Participants • Data is reported separately for parents and adolescents.	0 Participants n=21 Participants • Data is reported separately for parents and adolescents.	0 Participants n=45 Participants • Data is reported separately for parents and adolescents.
Race (NIH/OMB) Parent · Unknown or Not Reported	2 Participants n=24 Participants • Data is reported separately for parents and adolescents.	1 Participants n=21 Participants • Data is reported separately for parents and adolescents.	3 Participants n=45 Participants • Data is reported separately for parents and adolescents.
Race (NIH/OMB) Adolescent · American Indian or Alaska Native	0 Participants n=22 Participants • Data is reported separately for parents and adolescents.	0 Participants n=21 Participants • Data is reported separately for parents and adolescents.	0 Participants n=43 Participants • Data is reported separately for parents and adolescents.
Race (NIH/OMB) Adolescent · Asian	2 Participants n=22 Participants • Data is reported separately for parents and adolescents.	0 Participants n=21 Participants • Data is reported separately for parents and adolescents.	2 Participants n=43 Participants • Data is reported separately for parents and adolescents.
Race (NIH/OMB) Adolescent · Native Hawaiian or Other Pacific Islander	0 Participants n=22 Participants • Data is reported separately for parents and adolescents.	0 Participants n=21 Participants • Data is reported separately for parents and adolescents.	0 Participants n=43 Participants • Data is reported separately for parents and adolescents.
Race (NIH/OMB) Adolescent · Black or African American	2 Participants n=22 Participants • Data is reported separately for parents and adolescents.	0 Participants n=21 Participants • Data is reported separately for parents and adolescents.	2 Participants n=43 Participants • Data is reported separately for parents and adolescents.
Race (NIH/OMB) Adolescent · White	18 Participants n=22 Participants • Data is reported separately for parents and adolescents.	20 Participants n=21 Participants • Data is reported separately for parents and adolescents.	38 Participants n=43 Participants • Data is reported separately for parents and adolescents.
Race (NIH/OMB) Adolescent · More than one race	0 Participants n=22 Participants • Data is reported separately for parents and adolescents.	0 Participants n=21 Participants • Data is reported separately for parents and adolescents.	0 Participants n=43 Participants • Data is reported separately for parents and adolescents.
Race (NIH/OMB) Adolescent · Unknown or Not Reported	0 Participants n=22 Participants • Data is reported separately for parents and adolescents.	1 Participants n=21 Participants • Data is reported separately for parents and adolescents.	1 Participants n=43 Participants • Data is reported separately for parents and adolescents.