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

Overview

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).

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 imp
• 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.

Primary outcome measures

• 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]

Secondary outcome measures (5)

• Therapy Process Observational Coding System (TPOCS) [Time frame: 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 [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 Revised Children's Anxiety and Depression Scale-25 (RCADS) score [Time frame: Baseline, 3 months, 6 months]
• Change in DSM-5 Level 1 Cross-Cutting Symptom Measure score [Time frame: Baseline, 3 months, 6 months]
• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Peer Relationships score [Time frame: Baseline, 3 months, 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 1 center

• University of Washington — Seattle

Identifiers

NCT: NCT06941428 · STUDY00019451 · P50MH115837

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗