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Investigators will conduct a pilot efficacy test of a decision aid about contact sport participation post-concussion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | ||
| Decision Aid | Experimental | Usual care, plus introduction of a decision aid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Participants in the clinical trial component of this study will be adolescents, parents, and healthcare providers:
Adolescent Inclusion Criteria:
Parent Inclusion Criteria:
Healthcare Provider Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Participants received post-concussion care as usual. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
24 dyads were in the control phase and 46 individual participants (adolescents: n=22; parents: n=24) completed baseline surveys. Of the 31 dyads in the intervention phase, only 21 dyads completed the tool before their index visit and were therefore included in the analyses reported here; the remaining 10 dyads did not complete the tool in time and were excluded. Among the included dyads, 42 individual participants (adolescents: n= 21; parents: n=21) also completed baseline surveys.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Participants received post-concussion care as usual. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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). | Posted | Mean | Standard Deviation | Score on a scale | 3 months after initial clinic visit |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care - Parents | Participants received post-concussion care as usual. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emily Kroshus | Seattle Children's Research Institute | 206-884-5326 | Emily.Kroshus@seattlechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2022 | May 9, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Control Group | Jun 17, 2021 | May 9, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Intervention Group | Feb 28, 2022 | May 9, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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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), |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | 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. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Data is reported separately for parents and adolescents. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Data is reported separately for parents and adolescents. | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | 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), |
|
|
|
|
| Primary | 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." | The number analyzed in one or more rows differs from the overall number because results are reported separately by group (Parent, Adolescent). | Posted | Mean | Standard Deviation | score on a scale | Baseline: Within 1 week prior to the index clinic visit (i.e., first visit after enrolled in the study) |
|
|
|
| Primary | 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | Post-Index Visit: Within 24 hours after the index visit (typically occurs 1-2 weeks after enrollment), |
|
|
|
| Secondary | 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. | The number analyzed in one or more rows differs from the overall number because these analyses include only adolescent participants. | Posted | Mean | Standard Deviation | total mmw | 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 |
|
|
|
|
| Secondary | 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. | 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 . | Posted | Mean | Standard Deviation | Score on a scale | 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. |
|
|
|
|
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Decision Aid - Parents | 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. | 0 | 21 | 0 | 21 | 0 | 21 |
| EG002 | Usual Care - Adolescents | Participants received post-concussion care as usual. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG003 | Decision Aid - Adolescents | 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. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| Non-binary |
|
| Male |
|
| Non-binary |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Adolescent: Baseline |
|
|
| Parent: Post-Index Visit |
|
|
| Adolescent: Post-Index Visit |
|
|
| 0.854 |
| Superiority |
| Adolescent |
|
|
| Adolescent: Within family engagement |
|
|
| Parent: Family-clinician engagement |
|
|
| Adolescent: Family-clinician engagement |
|
|
| 3 Month Follow-up |
|
|
| 0.21 |
| Superiority |
| Post-Index Visit |
|
|
| 3-Month Follow-up |
|
|
| 0.96 |
| Superiority |
| 3 months after initial clinic visit | t-test, 2 sided | 0.96 | Superiority |