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NCT06036147 · ClinicalTrials.gov registry record · NA
Concussion Health Improvement Program
A NA study of Concussion, Brain and Brain Injury Traumatic Mild, sponsored by Seattle Children's Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 304
- Enrollment target
- 1
- Study location
NCT06036147 is a NA study of Concussion, Brain and Brain Injury Traumatic Mild that is actively recruiting participants, run by Seattle Children's Hospital. The registered enrollment target is 304 participants, above the 169-participant average among 20 other Concussion, Brain trials with a reported enrollment target (80% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06036147, a NA study of Concussion, Brain and Brain Injury Traumatic Mild, is actively recruiting participants, sponsored by Seattle Children's Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 304 participants
- Enrollment target
- 1
- Study location
Study Summary
More than 1 million U.S. youth sustain a concussion each year, and up to 30% report persistent post-concussive symptoms (PPCS) lasting 1 month or more. PPCS can interfere with normal adolescent development, resulting in issues with socioemotional dysfunction and even school failure. However, few evidence based treatments are available for youth with PPCS. The investigators conducted extensive work adapting a collaborative care framework for youth with PPCS, combining concussion-focused cognitive behavioral therapy (cf-CBT), parent skills training (PST) and care management (CM) to create a wraparound treatment for youth with PPCS that can be delivered either in-person or virtually. They completed an R01-funded randomized controlled trial with this approach, finding effectiveness for youth with PPCS, with improvements in concussive symptoms and quality of life at one year, and 60% of participants completing the intervention entirely virtually. Of note, this intervention is unique in that two of the components are focused on parents or parents and youth together (PST, CM), and only one of the components (cf-CBT) is solely youth focused. The investigators now propose to optimize and refine this approach, conducting a high efficiency MOST (multiphase optimization strategy) trial to assess the contribution of each of the three components (cf-CBT, PST and CM) to effectiveness, thereby enabling streamlining of the intervention to only include active components. The analysis will be factorial, with three intervention components and two levels of each (present or absent), resulting in 8 treatment pathways. The benefit of the MOST approach is that it combines all youth who receive a component, allowing assessment of all treatment components with only a modest sample size. The study will recruit 374 youth with PPCS, randomizing them to one of 8 treatment groups. Youth and/or parents will attend treatment sessions via video conferencing software over three months, and complete s
Conditions Studied
Interventions
- BEHAVIORAL Concussion-focused cognitive behavioral therapy
- BEHAVIORAL Parent skills training
- BEHAVIORAL Care management
Study Locations (1)
Texas
- University of Texas Southwestern (UTSW) - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2023-11-10 |
| Est. Completion | 2028-01-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06036147
The ClinicalTrials.gov registry entry for NCT06036147 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 304 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 169-participant average among 20 other Concussion, Brain trials with a reported enrollment target (80% higher). The listed sponsor is Seattle Children's Hospital, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Concussion, Brain appearing as the primary indexed condition, and to 3 interventions - of which Concussion-focused cognitive behavioral therapy is the first listed.
NCT06036147 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06036147 about?
NCT06036147 is a clinical study titled "Concussion Health Improvement Program". More than 1 million U.S. youth sustain a concussion each year, and up to 30% report persistent post-concussive symptoms (PPCS) lasting 1 month or more. PPCS can interfere with normal adolescent development, resulting in issues with socioemotional dysfunction and even school failure. However, few evi...
What is the current status of trial NCT06036147?
This trial is currently recruiting. It is a NA study. The enrollment target is 304 participants. The study started on 2023-11-10. Estimated completion is 2028-01-31.
What conditions does trial NCT06036147 study?
This clinical trial studies the following conditions: Concussion, Brain, Brain Injury Traumatic Mild.
What interventions are being tested in trial NCT06036147?
The interventions under investigation include: Concussion-focused cognitive behavioral therapy (BEHAVIORAL), Parent skills training (BEHAVIORAL), Care management (BEHAVIORAL).
Who is sponsoring clinical trial NCT06036147?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06036147 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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