Clinical trial NCT06941428: Systematic Redesign of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
Official title: Systematic Redesign of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) to Enhance Usability, Engagement, Appropriateness, and Impact in Schools
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma, Psychological
Trauma and Stressor Related Disorders
Keywords: School Mental Health
Trauma-Focused Cognitive Behavioral Therapy
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-04-23
Enrollment: 102
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Usability Scale (IUS) score
timeFrame: Baseline, 3 months, 6 months
measure: Change in Participant Responsiveness Scale (PRS) score
timeFrame: Baseline, 3 months, 6 months
measure: Change in Intervention Appropriateness Measure (IAM) score
timeFrame: Baseline, 3 months, 6 months
measure: Adoption over time
timeFrame: End of the individual's study participation period, assessed as the study withdrawal date or 24 months post-enrollment, whichever is first
measure: Reach over time
timeFrame: End of the individual's study participation period, assessed as the study withdrawal date or 24 months post-enrollment, whichever is first
measure: Change in Child Post-Traumatic Cognitions Inventory (CPTI) score
timeFrame: Baseline, 3 months, 6 months
measure: Change in Emotion Regulation Questionnaire-Child and Adolescent (ERQ-CA) score
timeFrame: Baseline, 3 months, 6 months
measure: Change in Posttraumatic Avoidance Behavior Questionnaire (PABQ) score
timeFrame: Baseline, 3 months, 6 months
measure: Change in Child PTSD Symptoms scale for DSM-V (CPSS-V) score
timeFrame: Baseline, 3 months, 6 months
measure: Change in Children Depression Inventory (CDI) score
timeFrame: Baseline, 3 months, 6 months
measure: Youth Top Problems (YTP) over time
timeFrame: Baseline, 3 months, 6 months
measure: Change in Quality of Life in Neurological Disorders Social Relations scale (Neuro-QOL) score
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Therapy Process Observational Coding System (TPOCS)
timeFrame: Expert clinicians review audiotapes of therapy sessions for each clinician participant over a six-month period of time after initial training
measure: Framework for Modifications and Adaptations of Evidence-Based Intervention
timeFrame: End of the individual's study participation period, assessed as the study withdrawal date or 24 months post-enrollment, whichever is first
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Aaron Lyon, PhD
role: PRINCIPAL_INVESTIGATOR
References: