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

NCT06941428 | Recruiting

• 2 other identifiers: STUDY00019451P50MH115837
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma, Psychological; Trauma and Stressor Related Disorders

Keywords

School Mental Health; Trauma-Focused Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (10)

• 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 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 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 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 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 Outcomes (5)

• Therapy Process Observational Coding System (TPOCS)

  Expert clinicians review audiotapes of therapy sessions for each clinician participant over a six-month period of time after initial training

• Framework for Modifications and Adaptations of Evidence-Based Intervention

  End of the individual's study participation period, assessed as the study withdrawal date or 24 months post-enrollment, whichever is first

• Change in Revised Children's Anxiety and Depression Scale-25 (RCADS) score

  Baseline, 3 months, 6 months

• Change in DSM-5 Level 1 Cross-Cutting Symptom Measure score

  Baseline, 3 months, 6 months

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Peer Relationships score

  Baseline, 3 months, 6 months

Study Arms (2)

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

ACTIVE COMPARATOR

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)

School-Adapted TF-CBT (S-TF)

EXPERIMENTAL

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)

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.

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

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.

School-Adapted TF-CBT (S-TF)

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98115, United States

RECRUITING

MeSH Terms

Conditions

Psychological Trauma; Trauma and Stressor Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Mental Disorders

Study Officials

• Aaron Lyon, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Osterhage

CONTACT

206-543-3350; katieost@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: June 22, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)