Trauma, PsychologicalNCT06941428
Systematic Redesign of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
A study testing Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and School-Adapted TF-CBT (S-TF) in people with Trauma, Psychological and Trauma and Stressor Related Disorders, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Trauma, Psychological, Trauma and Stressor Related Disorders
- What is being tested?
- Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and School-Adapted TF-CBT (S-TF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98115
Vaughan Collins, 206-616-0210, uwtrip@uw.edu
About this study
Official title: Systematic Redesign of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) to Enhance Usability, Engagement, Appropriateness, and Impact in Schools
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.
Read the 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).
- Being tested
- Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), School-Adapted TF-CBT (S-TF)
- Keywords
- School Mental Health, Trauma-Focused Cognitive Behavioral Therapy
- Medical subject headings
- Psychological Trauma, Trauma and Stressor Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: School-Adapted TF-CBT (S-TF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Baseline, 3 months, 6 months
Secondary outcomes (5)
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, 3 months, 6 months
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.
Measured: Baseline, 3 months, 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Peer Relationships score
PROMIS is a rigorously developed system of patient-reported outcome measures that enables standardized assessment of physical, mental, and social health across diverse patient populations.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start22 Jun 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Aaron Lyon, University of Washington
- Investigators
- Aaron Lyon, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941428
- Sponsor's protocol ID
- STUDY00019451
- Other IDs
- P50MH115837
- Status last verified
- Feb 2026
- First submitted
- 15 Apr 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Redesign of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) to Enhance Usability, Engagement, Appropriateness, and Impact in Schools
- ClinicalTrials.gov ID
- NCT06941428
- Acronym / sponsor ID
- STUDY00019451
- Keywords
- School Mental Health, Trauma-Focused Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 22 Jun 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) | Active comparator | Behavioral: 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. |
| School-Adapted TF-CBT (S-TF) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- Students with intellectual impairments documented in education or mental health records.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) |
| 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. | Behavioural | School-Adapted TF-CBT (S-TF) |
Primary outcome
Change in Usability Scale (IUS) score
Time frame: Baseline, 3 months, 6 months
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.
Change in Participant Responsiveness Scale (PRS) score
Time frame: Baseline, 3 months, 6 months
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.
Change in Intervention Appropriateness Measure (IAM) score
Time frame: Baseline, 3 months, 6 months
The Intervention Appropriateness Measure (IAM) is a rigorously developed, pragmatic instrument with strong good internal consistency (a = .87) and test-retest reliability (a = .87).
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
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.
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
Reach will be calculated using adoption data as the percentage of clinician's caseloads receiving TF-CBT or S-TF.
Change in Child Post-Traumatic Cognitions Inventory (CPTI) score
Time frame: Baseline, 3 months, 6 months
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).
Change in Emotion Regulation Questionnaire-Child and Adolescent (ERQ-CA) score
Time frame: Baseline, 3 months, 6 months
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.
Change in Posttraumatic Avoidance Behavior Questionnaire (PABQ) score
Time frame: Baseline, 3 months, 6 months
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).
Change in Child and Adolescent Trauma Screen 2 (CAT-2) score
Time frame: Baseline, 3 months, 6 months
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.
Youth Top Problems (YTP) over time
Time frame: Baseline, 3 months, 6 months
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).
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
Related trials for Trauma, Psychological
Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Not yet recruiting
Deaf CBT-TS to Reduce Suicide Risk
Depression - Major Depressive Disorder, Anxiety
Not yet recruiting
Magnetoencephalographic Correlates of Clinical Change After Cognitive Processing Therapy in Adults With PTSD
Trauma, Psychological, Traumatic Stress Disorder
RecruitingPhase 3
Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and Moral Injury
PTSD, Post Traumatic Stress Disorder, Moral Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aaron Lyon, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and School-Adapted TF-CBT (S-TF) in people with Trauma, Psychological and Trauma and Stressor Related Disorders, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katie Osterhage (206-543-3350, katieost@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Usability Scale (IUS) score (time frame: Baseline, 3 months, 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.