Redesigning Trauma-Focused Cognitive Behavioral Therapy for Schools
This study is testing two versions of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), a type of talk therapy for children who have experienced trauma. One version is the original TF-CBT, and the other is a redesigned version called School-Adapted TF-CBT (S-TF), which is made to be easier to use in schools. The goal is to see if S-TF is more practical and engaging for both providers and students in a school setting, and if it works as well as the original TF-CBT in helping students with trauma symptoms. The study plans to include 102 participants, including youth aged 7-19 who are receiving or have received school mental health services. Success will be measured by how usable, appropriate, and effective the therapies are over 6 months. The current status of this study is unclear.
- Study design
- This interventional study plans to enroll 102 participants. It will compare the original TF-CBT with a school-adapted version (S-TF).
- What's involved
- You would participate in either the original TF-CBT or the S-TF intervention. Your progress would be assessed at the start, 3 months, and 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months after starting the intervention.
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Systematic Redesign of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
At a glance
Conditions
NCT06941428
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Washington
Seattle, Washingtonstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Aaron Lyon, PhD · PRINCIPAL_INVESTIGATOR · University of Washington
Who to contact
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Inclusion
Exclusion
What this trial measures
- Change in Usability Scale (IUS) scoreBaseline, 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) scoreBaseline, 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) scoreBaseline, 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 timeEnd 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 timeEnd 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) scoreBaseline, 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) scoreBaseline, 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) scoreBaseline, 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) scoreBaseline, 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 timeBaseline, 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).