Recruiting

TF-CBT Adaptation

Sponsor:

University of Washington

Code:

NCT06941428

Conditions

Trauma, Psychological

Trauma and Stressor Related Disorders

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Not accepted

Interventions

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

School-Adapted TF-CBT (S-TF)

Study Details

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

Study ID

NCT06941428

Start date

Jun 22, 2025

Status verified date

Feb, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Not accepted

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 Design

Enrollment

102 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

  • Change in Usability Scale (IUS) score [ Time Frame: Baseline, 3 months, 6 months ]
  • Change in Participant Responsiveness Scale (PRS) score [ Time Frame: Baseline, 3 months, 6 months ]
  • Change in Intervention Appropriateness Measure (IAM) score [ Time Frame: Baseline, 3 months, 6 months ]
  • Adoption over time [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline, 3 months, 6 months ]
  • Change in Emotion Regulation Questionnaire-Child and Adolescent (ERQ-CA) score [ Time Frame: Baseline, 3 months, 6 months ]
  • Change in Posttraumatic Avoidance Behavior Questionnaire (PABQ) score [ Time Frame: Baseline, 3 months, 6 months ]
  • Change in Child and Adolescent Trauma Screen 2 (CAT-2) score [ Time Frame: Baseline, 3 months, 6 months ]
  • Youth Top Problems (YTP) over time [ Time Frame: Baseline, 3 months, 6 months ]

Central Contacts and Locations

Central contacts

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98115

Contacts

More Information

Sponsor

University of Washington

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • School Mental Health
  • Trauma-Focused Cognitive Behavioral Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-02-27.