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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH119148-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| University of Minnesota | OTHER |
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This research project is a hybrid type 2 effectiveness-implementation trial that simultaneously examines (1) the effectiveness of a trauma-focused intervention for youth in the education sector and (2) the impact of a theory-driven pragmatic implementation strategy designed to increase the adoption, fidelity, and sustainment of evidence-based treatments (EBTs). This trial will include 120 clinicians and 480 students, and it is designed to test the cost effectiveness and impact of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) in a new setting that increases access to mental health care - schools (Aim 1); test the cost effectiveness, immediate impact, and sustained impact of the Beliefs and Attitudes for Successful Implementation in Schools (BASIS) implementation strategy on proximal mechanisms and implementation outcomes (Aims 2a, 2b, 2d); and conduct sequential mixed-methods data collection to explain residuals (i.e., clinicians whose implementation behavior is unaccounted for by the mediation model) (Aim 2c).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BASIS with TF-CBT | Other | Implementation intervention: experimental arm (Beliefs and Attitudes for Successful Implementation in Schools) Clinical Intervention: experimental arm (Trauma-Focused CBT) |
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| Attention Control (AC) with TF-CBT | Other | Implementation intervention: control arm Clinical Intervention: experimental arm (Trauma-Focused CBT) |
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| Enhanced Treatment as Usual | Other | Implementation intervention: non-applicable Clinical Intervention: control arm (Enhanced TAU) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beliefs and Attitudes for Successful Implementation in Schools (BASIS) | Behavioral | BASIS blended (i.e., multifaceted and protocolized) implementation strategy, which occurs at the beginning of active implementation. BASIS is designed to facilitate observable implementation outcomes, including EBP adoption and intervention fidelity, via strategic education, motivational Interviewing, and social influence strategies. |
| Measure | Description | Time Frame |
|---|---|---|
| TF-CBT Adoption and Penetration | Participants provided data every 2-3 months for up to two years, reporting: How many students received CPSS-V (PTSD screener)? With how many students was TF-CBT initiated? With how many students was it completed? This allowed for monitoring of both reach (screening) and implementation (initiation/completion) of TF-CBT. | 18 Months- Active phase (timepoint 6 to 9); Sustainment phase (timepoint 10 to 12) |
| Child PTSD Symptom Scale for DSM-V | The Child PTSD Symptom Scale Self-Report for DSM-5 (CPSS-V) is a modified version of the original CPSS-SR adapted for DSM-5 criteria. The scale includes 20 PTSD symptom items scored on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("6 or more times a week / severe"), where higher scores indicate greater symptom severity. The scale includes 7 functioning items rated as "yes" or "no." The total score ranges from 0 to 80, with higher scores reflecting worse PTSD symptom severity. | 6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3) |
| Mood and Feelings Questionnaire - Short | The Short Mood and Feelings Questionnaire (SMFQ) is a 13-item self-report measure assessing recent emotional and behavioral states. It consists of descriptive phrases rated based on how often they applied to the subject over the past two weeks: 0 ("not at all"), 1 ("sometimes"), or 2 ("most of the time"). The total score ranges from 0 to 26, with higher scores indicating greater severity of depressive symptoms (worse outcome). | 6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3) |
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Clinicians will be included if they (a) provide school-based services in a participating district; (b) have not previously received formal training in TF-CBT; and (c) are not actively receiving support to implement another trauma-focused intervention.
Students subjects will meet TF-CBT eligibility criteria, including (a) be within the TF-CBT developmental range (ages 8 to 19), (b) have traumatic event exposure (e.g., exposure to violence), and (c) significant post-traumatic stress symptoms.
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Lyon, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33413511 | Derived | Lyon AR, Pullmann MD, Dorsey S, Levin C, Gaias LM, Brewer SK, Larson M, Corbin CM, Davis C, Muse I, Joshi M, Reyes R, Jungbluth NJ, Barrett R, Hong D, Gomez MD, Cook CR. Protocol for a hybrid type 2 cluster randomized trial of trauma-focused cognitive behavioral therapy and a pragmatic individual-level implementation strategy. Implement Sci. 2021 Jan 7;16(1):3. doi: 10.1186/s13012-020-01064-1. |
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School districts across the United States were recruited to participate in the study, where the district leaders provided a list of potential eligible clinicians currently employed in schools in the district. The eligibility criteria for clinicians were a) provided school-based services for the participating school district; b) did not receive formal training in TF-CBT or CBT+; c) did not receive support to implement another trauma-focused intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | BASIS With TF-CBT (Provider) | Participants who received training for the implementation intervention BASIS and the clinical intervention, trauma-focused CBT. |
| FG001 | AC (Attention Control) With TF-CBT (Provider) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 5, 2025 |
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The care provider is not masked to the intervention condition they are in (ie, TF-CBT vs TAU), but will be masked to the implementation strategy (ie, Attention Control vs. BASIS).
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| Trauma-Focused Cognitive-Behavioral Therapy | Behavioral | TF-CBT is an evidence-based treatment that helps children from elementary to high school to address the negative effects of trauma and promote greater emotion and behavior regulation, including processing their traumatic memories, overcoming problematic thoughts and behaviors, and developing effective coping and interpersonal skills. It also includes a treatment component for parents or other caregivers. Parents can learn skills related to stress management, positive parenting, behavior management, and effective communication. |
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| Treatment as Usual | Behavioral | Scaffolded intervention as usual. Includes: initial assessment of trauma symptoms, psychoeducation, follow-up planning and support. |
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| Attention Control | Behavioral | Didactic presentation of implementation-related content (e.g., information about the importance of implementing, definitions of key terms, etc.) to control for facilitator, dose, information provided, and delivery platform |
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Participants who received control for the implementation intervention and training for trauma-focused CBT for clinical intervention.
| FG002 | Enhanced Treatment as Usual (Provider) | Participants who received control for both implementation and clinical intervention. |
| FG003 | BASIS With TF-CBT (Students) | Students recruited by providers who received training for the interventions: implementation (BASIS) and clinical (TF-CBT). |
| FG004 | AC (Attention Control) With TF-CBT (Student) | Students recruited by providers who received control for the implementation intervention and training for TF-CBT for clinical intervention. |
| FG005 | Enhanced Treatment as Usual (Student) | Students recruited by providers who received control for both implementation and clinical intervention. |
| End of Training Period (Provider) |
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| End of Active Phase of the Study (Provider) |
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| 3-month Follow up (Student) |
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| COMPLETED |
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| NOT COMPLETED |
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The eligibility criteria for clinicians: a) provided school-based services for the participating school district; b) did not receive formal training in TF-CBT or CBT+; c) did not receive support to implement another trauma-focused intervention.
Eligible students recruited by participating providers: a) within the TF-CBT development age ( 8-19); b) experienced a traumatic event exposure (e.g., exposure to violence); and c) significant post-traumatic stress symptoms.
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| ID | Title | Description |
|---|---|---|
| BG000 | BASIS With TF-CBT (Provider) | Participants who received training for the implementation intervention BASIS and the clinical intervention, trauma-focused CBT. |
| BG001 | AC (Attention Control) With TF-CBT (Provider) | Participants who received control for the implementation intervention and training for trauma-focused CBT for clinical intervention. |
| BG002 | Enhanced Treatment as Usual (Provider) | Participants who received control for both implementation and clinical intervention. |
| BG003 | BASIS With TF-CBT (Students) | Students recruited by providers who received training for the interventions: implementation (BASIS) and clinical (TF-CBT). |
| BG004 | AC (Attention Control) With TF-CBT (Student) | Students recruited by providers who received control for the implementation intervention and training for TF-CBT for clinical intervention. |
| BG005 | Enhanced Treatment as Usual (Student) | Students recruited by providers who received control for both implementation and clinical intervention. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
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| Age, Continuous | Students were recruited by providers who participated in the study. The students needed to be a) within the TF-CBT development range (age 8-19), b) experienced a traumatic event (e.g., exposure to violence), and c) have significant post-traumatic stress symptoms. Only categorical age was collected for provider participants; therefore, the mean and standard deviation cannot be calculated. | Mean | Standard Deviation | Years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | TF-CBT Adoption and Penetration | Participants provided data every 2-3 months for up to two years, reporting: How many students received CPSS-V (PTSD screener)? With how many students was TF-CBT initiated? With how many students was it completed? This allowed for monitoring of both reach (screening) and implementation (initiation/completion) of TF-CBT. | Of the randomized participants, the overall number of participants analyzed was still active after the training period. The measure breaks down the number of providers who administered the screener with at least one student, and then adopted (started or completed) the trauma-informed intervention with at least one student. | Posted | Count of Participants | Participants | 18 Months- Active phase (timepoint 6 to 9); Sustainment phase (timepoint 10 to 12) |
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| Primary | Child PTSD Symptom Scale for DSM-V | The Child PTSD Symptom Scale Self-Report for DSM-5 (CPSS-V) is a modified version of the original CPSS-SR adapted for DSM-5 criteria. The scale includes 20 PTSD symptom items scored on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("6 or more times a week / severe"), where higher scores indicate greater symptom severity. The scale includes 7 functioning items rated as "yes" or "no." The total score ranges from 0 to 80, with higher scores reflecting worse PTSD symptom severity. | All the participants (students) who received trauma-informed intervention- TF-CBT or Enhanced treatment as usual. | Posted | Mean | Standard Deviation | Score on a scale | 6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3) |
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| Primary | Mood and Feelings Questionnaire - Short | The Short Mood and Feelings Questionnaire (SMFQ) is a 13-item self-report measure assessing recent emotional and behavioral states. It consists of descriptive phrases rated based on how often they applied to the subject over the past two weeks: 0 ("not at all"), 1 ("sometimes"), or 2 ("most of the time"). The total score ranges from 0 to 26, with higher scores indicating greater severity of depressive symptoms (worse outcome). | All the participants (students) who received trauma-informed intervention- TF-CBT or Enhanced Treatment as Usual. | Posted | Mean | Standard Deviation | score on a scale | 6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3) |
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6 months- Baseline (T1), 3-month follow up (T2), 6-month follow up (T3)
Any adverse events (including serious ones) were only collected for students (none collected for providers). Identified through a CPSS-V item assessing self-harm (other adverse event). If a student scored >0 ('not at all') on this item, the protocol followed:
Notifying the school mental health provider (provider participant) and the parent (with the student's consent). Based on the severity, escalating to the on-call study clinician to develop a safety plan.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | BASIS With TF-CBT (Student) | Students recruited by providers who received training for the interventions: implementation (BASIS) and clinical (TF-CBT). | 0 | 34 | 0 | 34 | 3 | 34 |
| EG001 | Attention Control With TF-CBT (Student) | Students recruited by providers who received control for the implementation intervention and training for TF-CBT for clinical intervention. | 0 | 32 | 0 | 32 | 4 | 32 |
| EG002 | Enhanced Treatment as Usual (Student) | Students recruited by providers who received control for both implementation and clinical intervention. | 0 | 35 | 0 | 35 | 2 | 35 |
| EG003 | BASIS With TF-CBT (Provider) | Participants who received training for the implementation intervention BASIS and the clinical intervention, trauma-focused CBT. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | AC (Attention Control) With TF-CBT (Provider) | Participants who received control for the implementation intervention and training for trauma-focused CBT for clinical intervention. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Enhanced Treatment as Usual (Provider) | Participants who received control for both implementation and clinical intervention. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation/ Self-harm | Social circumstances | Other | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aaron Lyon | University of Washington | (206) 221-8604 | lyona@uw.edu |
| Jun 25, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 21, 2021 | Jun 25, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000067073 | Psychological Trauma |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D012574 | Schools |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D000072182 | Non-Medical Public and Private Facilities |
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| Completed TF-CBT with at least one student. |
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| The primary TF-CBT adoption outcome (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group. | Chi-squared | 0.032 | We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student by the end of the active phase. | Superiority |
| One of the primary TF-CBT adoption outcomes (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student at the end of the sustainment phase, or they did not. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group. | Chi-squared | 0.054 | We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student by the end of the sustainment phase. | Superiority |
| The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not at the beginning of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group. | Chi-squared | 0.98 | We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student at the beginning of the active phase. | Superiority |
| The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group. | Chi-squared | 0.068 | We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student by the end of the active phase. | Superiority |
| The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the sustainment phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group. | Chi-squared | 0.165 | We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student by the end of the sustainment phase. | Superiority |
| The primary TF-CBT adoption outcome (defined as completed TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group. | Chi-squared | 0.191 | We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants completed TF-CBT with at least one student by the end of the active phase. | Superiority |
| The primary TF-CBT adoption outcome (defined as completed TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the sustainment phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group. | Chi-squared | 0.86 | We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants completed TF-CBT with at least one student at the end of the sustainment phase. | Superiority |
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