NCT06941428

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

Systematic Redesign of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) to Enhance Usability, Engagement, Appropriateness, and Impact in Schools

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigators will compare DDBT mechanisms (usability, engagement, appropriateness) and implementation outcomes (adoption, fidelity, adaptation, reach) for local school-adapted TF-CBT (S-TF) versus original TF-CBT (TF-CBT). Although the content of the intervention will be redesigned, basic training format and implementation structures (e.g., online training, live workshop, role plays, consultation) will be held constant across conditions. The investigators hypothesize: H-1: S-TF will demonstrate greater usability, engagement, and appropriateness than TF-CBT. H-2: S-TF will demonstrate greater adoption, fidelity, reach, degree of implementation, and fewer reactive adaptations, than TF-CBT. The investigators will also evaluate the potential impact of S-TF versus TF-CBT for students experiencing elevated trauma symptoms on TF-CBT mechanisms (trauma-related cognitions, emotion regulation, behavioral avoidance) and mental health outcomes (e.g., symptoms of post-traumatic stress). The investigators hypothesize: H-3: Across conditions, more clients will experience significant clinical improvement than will deteriorate or remain unchanged. H-4: S-TF will demonstrate noninferiority to TF-CBT on treatment mechanisms (trauma-related cognitions, emotional regulation, and behavioral avoidance). H-5: S-TF will demonstrate noninferiority to TF-CBT on student mental health outcomes (symptoms).

Conditions

• Trauma, Psychological
• Trauma and Stressor Related Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)	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.
BEHAVIORAL	School-Adapted TF-CBT (S-TF)	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.

Timeline

• Start date: 2025-06-22
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-04-23
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States