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

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.

Study Overview

• Status: Recruiting
• Conditions: Trauma and Stressor Related Disorders; Trauma, Psychological
• Intervention / Treatment: Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT); Behavioral: School-Adapted TF-CBT (S-TF)

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).

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katie Osterhage; Phone Number: 206-543-3350; Email: katieost@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98115
      • Recruiting
      • University of Washington
      • Contact: Vaughan Collins; Phone Number: 206-616-0210; Email: uwtrip@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Participant Responsiveness Scale (PRS) score	Engagement will be measured using the Participant Responsiveness Scale (PRS), an adapted version of the 12-item Patient Responsiveness Scale tailored to be developmentally appropriate for children aged 8 and above as well as adults. The PRS measures two factors, Participation and Enthusiasm. The original Patient Responsiveness Scale has demonstrated strong reliability (a = .86) and construct validity.	Baseline, 3 months, 6 months
Change in Intervention Appropriateness Measure (IAM) score	The Intervention Appropriateness Measure (IAM) is a rigorously developed, pragmatic instrument with strong good internal consistency (a = .87) and test-retest reliability (a = .87).	Baseline, 3 months, 6 months
Adoption over time	Adoption is operationalized as the initiation of a clinician's first TF-CBT or S-TF session at any point during study participation. These data will be collected from an online Toolkit that facilitates tracking of services delivered and has been commonly used for large-scale TF-CBT implementation.	End of the individual's study participation period, assessed as the study withdrawal date or 24 months post-enrollment, whichever is first
Reach over time	Reach will be calculated using adoption data as the percentage of clinician's caseloads receiving TF-CBT or S-TF.	End of the individual's study participation period, assessed as the study withdrawal date or 24 months post-enrollment, whichever is first
Change in Child Post-Traumatic Cognitions Inventory (CPTI) score	The Child Post-Traumatic Cognitions Inventory (CPTI) is a 25-item measure for youth aged 6-18 that is applicable to a wide range of trauma experiences. Two subscales, (1) Permanent and disturbing change (in response to trauma) and (2) Fragile person in a scary world have been identified. Both subscales have high internal consistency (a = .91 and .87, respectively)and test-retest reliability (r= .78 and .72).	Baseline, 3 months, 6 months
Change in Posttraumatic Avoidance Behavior Questionnaire (PABQ) score	The Posttraumatic Avoidance Behavior Questionnaire (PABQ) is a 25-item self-report measuring trauma-related avoidance behavior (e.g., avoiding visual trauma reminders, being alone, intimate relationships) on a 4-point Likert scale. The PABQ has good test-retest validity (r = .87 - .78) and convergent validity with PTSD symptom severity (r= .77 - .56).	Baseline, 3 months, 6 months
Change in Usability Scale (IUS) score	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 young as 11 years. For youth <11, we will use an adapted lUS, modeled after an adapted version of the SUS for children as young as 7 years old and demonstrating adequate to good reliability.	Baseline, 3 months, 6 months
Change in Emotion Regulation Questionnaire-Child and Adolescent (ERQ-CA) score	The Emotion Regulation Questionnaire-Child and Adolescent (ERQ-CA) is a 10-item instrument that has demonstrated good construct validity, inter-item consistency (a = .73 - .79), and test-retest reliability (r = .69) across multiple studies for children aged 7 - 18 years.	Baseline, 3 months, 6 months
Change in Child and Adolescent Trauma Screen 2 (CAT-2) score	The Child and Adolescent Trauma Screen-2 (CATS) is checklist administered as a youth self-report and caregiver report that is based on DSM-5 criteria for PTSD and the items directly map onto criteria B (intrusions, a = .80 and .86), C (avoidance, a = .67 and .68), D (negative alterations in cognitions and mood, a = .85 and .87), and E (hyperarousal, a = .74 and .83). Using a set of 15 items, potentially traumatic events or series of events are identified followed by 20 posttraumatic stress symptoms (PTSS) items if at least one potentially traumatic event is evident. Both the youth self-report (a = .92) and caregiver report (a = .94) demonstrate excellent internal consistency. PTSS items are rated on a scale of 0 (never) to 3 (almost always) followed by 5 psychosocial functioning items (yes/no) related to the PTSS. This will be used to initially identify youth for study participation.	Baseline, 3 months, 6 months
Youth Top Problems (YTP) over time	The Youth Top Problems (YTP) assessment is an assessment in which youth and caregivers are asked to list the problems they were most concerned about. Upon completion of the list, respondents are asked to assign a severity rating for each problem by answering the questions: how big of a problem is this for you? (0 = not at all to 10 = very, very much). Respondents are then asked to identify which of the problems listed: is the biggest problem right now? Which one is the most important to work on?. Then the second and third most important until 3 top problems are identified. The YTP shows excellent concurrence with standardized assessments (Kappa ranging from .78 to .91), while also adding specificity for treatment targets (41% of caregivers-, and 79% of youth-identified top problems were not identified by an item amongst elevated standardized assessment sub-scales).	Baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Framework for Modifications and Adaptations of Evidence-Based Intervention	Recorded intervention sessions will be evaluated using the coding system for the Framework for Modifications and Adaptations of Evidence-based interventions (FRAME), the leading method for evaluating the nature of intervention adaptations.	End of the individual's study participation period, assessed as the study withdrawal date or 24 months post-enrollment, whichever is first
Therapy Process Observational Coding System (TPOCS)	For each case, one recording will be randomly selected from each TF-CBT / S-TF treatment phase and coded for fidelity using the Therapy Process Observational Coding System (TPOCS), and the TPOCS-SeRTIFY self-report measure version.	Expert clinicians review audiotapes of therapy sessions for each clinician participant over a six-month period of time after initial training
Change in Revised Children's Anxiety and Depression Scale-25 (RCADS) score	The RCADS-25 is a psychometrically validated tool that screens and monitors anxiety and depression symptoms in 8- to 18-year-old youth through child or parent report using a 4-point Likert scale.	Baseline, 3 months, 6 months
Change in DSM-5 Level 1 Cross-Cutting Symptom Measure score	The DSM-5 Level 1 Cross-Cutting Symptom Measure is a 23-item survey that screens for the presence and severity of symptoms spanning 13 psychiatric domains, enabling clinicians to identify trans-diagnostic mental health concerns. This measure is administered as a self-report for youth ages 11 - 17 and completed by a caregiver for youth under the age of 11.	Baseline, 3 months, 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Peer Relationships score	PROMIS is a rigorously developed system of patient-reported outcome measures that enables standardized assessment of physical, mental, and social health across diverse patient populations.	Baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Aaron Lyon, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Trauma-Focused Cognitive Behavioral Therapy; School Mental Health
• Additional Relevant MeSH Terms: Mental Disorders; Stress Disorders, Traumatic; Psychological Trauma; Trauma and Stressor Related Disorders
• Other Study ID Numbers: STUDY00019451; P50MH115837 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No