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NCT02268240 · ClinicalTrials.gov registry record · NA
Care for Post-Concussive Symptoms
A NA study, sponsored by Seattle Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 49
- Enrollment target
NCT02268240 is a NA study that has completed, run by Seattle Children's Hospital. The registered enrollment target is 49 participants.
The verdict
NCT02268240, a NA study, has completed, sponsored by Seattle Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 49 participants
- Enrollment target
Study Summary
The proposed study is a pilot randomized trial of a stepped collaborative care intervention designed to decrease post-concussive symptoms and improve post-injury functioning among sports-injured youth aged 11-17. Participants with persistent post-concussive symptoms (symptoms persisting at least two months post-injury) will be recruited from Seattle Children's Hospital departments of sports medicine and rehabilitation medicine. Consent and assent will be obtained in-person. Participants will be randomized to receive either the stepped collaborative care intervention, or treatment-as-usual. Participants will be assessed on a range of symptoms and areas of functioning at four time points: 0 months, 1 month, 3 months, and 6 months after enrollment. The primary hypothesis is that the intervention group athletes, when compared to usual care control group athletes, will demonstrate clinically and statistically significant reductions in postconcussive, anxiety, and depressive symptoms over the course of the 6-month study. Secondary analyses will assess the impact of the intervention on functional impairment including missed school days and other academic outcomes. Exploratory analyses will examine MRI findings that are characteristic of postconcussive neuropathology, if available in medical record, as predictors of treatment responses.
Interventions
- BEHAVIORAL Stepped Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2014-10 |
| Est. Completion | 2016-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02268240
The ClinicalTrials.gov registry entry for NCT02268240 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Children's Hospital, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Stepped Care is the first listed.
NCT02268240 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02268240 about?
NCT02268240 is a clinical study titled "Care for Post-Concussive Symptoms". The proposed study is a pilot randomized trial of a stepped collaborative care intervention designed to decrease post-concussive symptoms and improve post-injury functioning among sports-injured youth aged 11-17. Participants with persistent post-concussive symptoms (symptoms persisting at least two...
What is the current status of trial NCT02268240?
This trial is currently completed. It is a NA study. The enrollment target is 49 participants. The study started on 2014-10. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02268240?
The interventions under investigation include: Stepped Care (BEHAVIORAL).
Who is sponsoring clinical trial NCT02268240?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
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