Systematic Redesign of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT06941428
Status
Recruiting
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Conditions

  • Trauma and Stressor Related Disorders
  • Trauma, Psychological

Eligibility Criteria

Sex
ALL
Age
7 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) — BEHAVIORAL
    TF-CBT is a cognitive-behavioral individual intervention for children aged 3 to 18 years with trauma exposure and related mental health sequelae.TF-CBT core components include psychoeducation, relaxation skills, affective regulation skills, cognitive coping skills, construction of a trauma narrative to facilitate imaginal exposure and cognitive processing of the traumatic events, and in vivo exposure to trauma reminders. TF-CBT is hypothesized to operate on specific mechanisms that influence improvements in clinical outcomes.
  • School-Adapted TF-CBT (S-TF) — BEHAVIORAL
    S-TF is a version of Trauma-Focused Cognitive Behavioral Therapy modified for delivery by providers in the education sector. Although modifications will be determined by Study 1 activities, we anticipate that S-TF might modify treatment pacing, session length, or content sequencing. Regardless, the core functions of TF-CBT will be retained in the S-TF redesign.

Study Details

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.

Key Dates

Start date
Jun 22, 2025
Status verified
Feb 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
    Participants in this arm will receive TF-CBT gold-standard training and 6 months of follow-up consultation will be delivered by a certified trainer.
  • Experimental: School-Adapted TF-CBT (S-TF)
    Participants in this arm will receive S-TF training and consultation procedures will align with those for TF-CBT to ensure comparable training/consultation dose.

Primary Outcome Measure

Change in Usability Scale (IUS) score [ Time Frame: Baseline, 3 months, 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98115
Vaughan Collins
[email protected]
206-616-0210

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By research site
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