---
title: Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians
nct_id: NCT04777864
overall_status: COMPLETED
phase: NA
sponsor: "Seattle Children's Hospital"
study_type: INTERVENTIONAL
primary_condition: Concussion, Brain
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04777864.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04777864"
ct_last_update_post_date: 2025-09-04
last_seen_at: "2026-05-12T06:35:53.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians

**NCT ID:** [NCT04777864](https://clinicaltrials.gov/study/NCT04777864)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 110
- **Lead Sponsor:** Seattle Children's Hospital
- **Conditions:** Concussion, Brain
- **Start Date:** 2021-08-30
- **Completion Date:** 2024-04-01
- **CT.gov Last Update:** 2025-09-04

## Brief Summary

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

## 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.

## Eligibility

- **Minimum age:** 11 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **Usual Care** (NO_INTERVENTION)
- **Decision Aid** (EXPERIMENTAL) — Usual care, plus introduction of a 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.

## Primary Outcomes

- **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.

## 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.)_

## Locations (1)

- Seattle Children's Hospital, Seattle, Washington, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.seattle children's hospital|seattle|washington|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04777864.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04777864*  
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