Systematic Redesign of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7+
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
BehavioralTF-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)
BehavioralS-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.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)Active comparator 1 intervention
Group B: School-Adapted TF-CBT (S-TF)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 3 months, 6 months2
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.
Time frame
Baseline, 3 months, 6 months3
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).
Time frame
Baseline, 3 months, 6 months4
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.
Time frame
End of the individual's study participation period, assessed as the study withdrawal date or 24 months post-enrollment, whichever is firstSecondary outcomes
1
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.
Time frame
Expert clinicians review audiotapes of therapy sessions for each clinician participant over a six-month period of time after initial training2
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.
Time frame
End of the individual's study participation period, assessed as the study withdrawal date or 24 months post-enrollment, whichever is first3
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.
Time frame
Baseline, 3 months, 6 months4
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.
Time frame
Baseline, 3 months, 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov