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NCT06941428 · ClinicalTrials.gov registry record · NA
Systematic Redesign of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
A NA study of Trauma, Psychological and Trauma and Stressor Related Disorders, sponsored by University of Washington.
- Recruiting
- Registry status
- NA
- Development phase
- 102
- Enrollment target
- 1
- Study location
NCT06941428: Recruiting NA study of Trauma, Psychological and Trauma and Stressor Related Disorders, sponsored by University of Washington.
NCT06941428 is a NA study of Trauma, Psychological and Trauma and Stressor Related Disorders that is actively recruiting participants, run by University of Washington. The registered enrollment target is 102 participants, below the 117-participant average among 14 other Trauma, Psychological trials with a reported enrollment target (13% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06941428, a NA study of Trauma, Psychological and Trauma and Stressor Related Disorders, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- NA
- Development phase
- 102 participants
- Enrollment target
- 1
- Study location
Study Summary
Trauma-focused cognitive behavior therapy (TF-CBT) has the strongest evidence of any clinical intervention for youth trauma but is rarely adopted in the education sector - the most common setting for youth mental healthcare. Use of TF-CBT in schools is limited by (1) problems with its usability (e.g., rigid structures, complicated patient identification workflows) and (2) provider perceptions that some core elements (e.g., exposure) are not contextually appropriate for schools; both of which hinder provider and student engagement with TF-CBT. Our preliminary studies identified that TF-CBT demonstrates "below average" usability, suggesting that many providers are likely to experience it as excessively onerous (e.g., due to lengthy sessions, low caregiver engagement). Without a systematic process for redesign, treatment adaptations made to improve intervention-setting fit can be reactive and risk omitting their core elements or functions. Locally driven, user focused redesign of TF-CBT for schools that maintains its core functions can enhance the accessibility and impact of evidence-based trauma treatment for youth. In light of the need for usable, contextually appropriate, and engaging interventions for youth trauma, the current project will iteratively adapt TF-CBT for use by school-based providers (e.g., school counselors, school social workers) via the University of Washington ALACRITY Center's (UWAC) Discover, Design/Build, Test (DDBT) approach and methods drawn from the field of human-centered design.
Primary Outcome
Usability will be evaluated with the 10-item Intervention Usability Scale (IUS), which is based closely on the well-validated SUS. Ratings are on a 1 to 5 scale and yield a total score from 0 to 100. Half the items are reverse scored; higher total scores reflect greater usability. The IUS has good inter-item consistency (a = .83) and sensitivity. Research has also demonstrated that the original version of the IUS (the SUS) function similarly, and yields similar scores, for adults and youth as yo
Conditions Studied
Interventions
- BEHAVIORAL Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
- BEHAVIORAL School-Adapted TF-CBT (S-TF)
Study Locations (1)
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2025-06-22 |
| Est. Completion | 2027-03-01 |
| Phase | NA |
What NCT06941428 shows while recruiting
NCT06941428 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 117-participant average among 14 other Trauma, Psychological trials with a reported enrollment target (13% lower).
The record links to 2 conditions, with Trauma, Psychological appearing as the primary indexed condition, and to 2 interventions - of which Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is the first listed.
NCT06941428 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT06941428 about?
NCT06941428 is a clinical study titled "Systematic Redesign of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)". Trauma-focused cognitive behavior therapy (TF-CBT) has the strongest evidence of any clinical intervention for youth trauma but is rarely adopted in the education sector - the most common setting for youth mental healthcare. Use of TF-CBT in schools is limited by (1) problems with its usability (e.g...
What is the current status of trial NCT06941428?
This trial is currently recruiting. It is a NA study. The enrollment target is 102 participants. The study started on 2025-06-22. Estimated completion is 2027-03-01.
What conditions does trial NCT06941428 study?
This clinical trial studies the following conditions: Trauma, Psychological, Trauma and Stressor Related Disorders.
What interventions are being tested in trial NCT06941428?
The interventions under investigation include: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) (BEHAVIORAL), School-Adapted TF-CBT (S-TF) (BEHAVIORAL).
Who is sponsoring clinical trial NCT06941428?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06941428 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06941428's enrollment target sits among peer trials
102 8th of 14 higher than 7 of 14 other Trauma, Psychological trials
participants (enrollment target), bucketed by value
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