NCT06941428 Systematic Redesign of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
| NCT ID | NCT06941428 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Trauma, Psychological |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2025-06-22 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 102 participants in total. It began in 2025-06-22 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
INCLUSION CRITERIA Discover, Design/Build Phase: * Providers. Providers will be included if they (a) deliver mental health treatment on school grounds; (b) English speaking. * Students. Youth participants will meet eligibility criteria for this study, including (a) be within the TF-CBT developmental range, ages 7-19; (b) are receiving, or have previously received, school mental health services; and (c) are English speaking. Test Phase: * Providers. Providers will be included if they (a) deliver mental health treatment on school grounds; (b) have not previously received formal training in TF-CBT; and (c) are English speaking * Students. Youth participants will meet eligibility criteria for this study, including (a) be within the TF-CBT developmental range, ages 7-19; (b) have traumatic event exposure (e.g., exposure to violence); (c) demonstrate significant post-traumatic stress symptoms (have a trauma history as defined as a score \>31 on the Child PTSD Symptoms Scale for DSM-V \[CPSS-V\]); and (d) are English speaking. EXCLUSION CRITERIA Discover, Design/Build Phase: \- Students with intellectual impairments documented in education or mental health records. Test Phase: * Providers. Providers will be excluded if they participated in the redesign process for TF-CBT. * Students. Students will be excluded if they (a) have intellectual impairments documented in education or mental health records and (2) are not trauma exposed.
Contact & Investigator
Aaron Lyon, PhD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT06941428 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, studying Trauma, Psychological. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06941428 currently recruiting?
Yes, NCT06941428 is actively recruiting participants. Contact the research team at katieost@uw.edu for enrollment information.
Where is the NCT06941428 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT06941428 clinical trial?
NCT06941428 is sponsored by University of Washington. The principal investigator is Aaron Lyon, PhD at University of Washington. The trial plans to enroll 102 participants.