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

NCT06941428 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-02-27

No results posted yet for this 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.

Conditions

  • Trauma, Psychological
  • Trauma and Stressor Related Disorders

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Aaron Lyon, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-22
Primary Completion
2027-03-01
Completion
2027-03-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06941428 on ClinicalTrials.gov