An interventional study of Beliefs and Attitudes for Successful Implementation in Schools (BASIS) and Trauma-Focused Cognitive-Behavioral Therapy in Evidence-Based Practices, CBT and School Health Services, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 7 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by University of Washington · Not applicable, Interventional, and Health services research
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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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.
Implementation intervention: experimental arm (Beliefs and Attitudes for Successful Implementation in Schools) Clinical Intervention: experimental arm (Trauma-Focused CBT)
Behavioral: Beliefs and Attitudes for Successful Implementation in Schools (BASIS) · Behavioral: Trauma-Focused Cognitive-Behavioral Therapy
Implementation intervention: control arm Clinical Intervention: experimental arm (Trauma-Focused CBT)
Behavioral: Trauma-Focused Cognitive-Behavioral Therapy · Behavioral: Attention Control
Implementation intervention: non-applicable Clinical Intervention: control arm (Enhanced TAU)
Behavioral: Treatment as Usual
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.
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.
Scaffolded intervention as usual. Includes: initial assessment of trauma symptoms, psychoeducation, follow-up planning and support.
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
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.
Time frame: 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.
Time frame: 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).
Time frame: 6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3)
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.
| Milestone | BASIS With TF-CBT (Provider) | AC (Attention Control) With TF-CBT (Provider) | Enhanced Treatment as Usual (Provider) | BASIS With TF-CBT (Students) | AC (Attention Control) With TF-CBT (Student) | Enhanced Treatment as Usual (Student) |
|---|---|---|---|---|---|---|
| Started | 62 | 65 | 64 | 34 | 32 | 35 |
| End of training period (provider) | 47 | 45 | 54 | 0 | 0 | 0 |
| End of active phase of the study (provider) | 37 | 30 | 48 | 0 | 0 | 0 |
| 3-month follow up (student) | 0 | 0 | 0 | 26 | 24 | 21 |
| Completed | 31 | 28 | 42 | 21 | 19 | 17 |
| Not completed | 31 | 37 | 22 | 13 | 13 | 18 |
| Withdrew: Lost to follow-up | 28 | 37 | 22 | 13 | 11 | 14 |
| Withdrew: Withdrawal by subject | 3 | 0 | 0 | 0 | 2 | 4 |
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.
| Participants | BASIS With TF-CBT (Provider) | AC (Attention Control) With TF-CBT (Provider) | Enhanced Treatment as Usual (Provider) |
|---|---|---|---|
| Administered CPSS-V with at least one student. | 33 | 26 | 33 |
| Started TF-CBT with at least one student. | 31 | 26 | 21 |
| Completed TF-CBT with at least one student. | 11 | 12 | 19 |
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.
| Score on a scale | BASIS With TF-CBT (Student) | Attention Control With TF-CBT (Student) | Enhanced Treatment as Usual (Student) |
|---|---|---|---|
| Baseline (T1) | 34.7 ± 15.9 | 39.3 ± 18.7 | 37.1 ± 16.1 |
| 3-month follow up (T2) | 28.3 ± 16.2 | 34.4 ± 16.2 | 28.1 ± 17.4 |
| 6-month follow up (T3) | 26.1 ± 17.7 | 32.2 ± 18.8 | 19.4 ± 16.3 |
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).
| score on a scale | BASIS With TF-CBT (Student) | Attention Control With TF-CBT (Student) | Enhanced Treatment as Usual (Student) |
|---|---|---|---|
| Baseline (T1) | 10.3 ± 7.7 | 11.7 ± 7.1 | 10.7 ± 5.9 |
| 3-month follow up (T2) | 7.7 ± 4.8 | 12.1 ± 6.3 | 7.2 ± 4.4 |
| 6-month follow-up (T3) | 6.8 ± 6.3 | 10 ± 7.3 | 4.9 ± 4.3 |
Collected over 6 months- Baseline (T1), 3-month follow up (T2), 6-month follow up (T3). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BASIS With TF-CBT (Student) | 0/34 (0%) | 0/34 (0%) | 3/34 (8.8%) |
| Attention Control With TF-CBT (Student) | 0/32 (0%) | 0/32 (0%) | 4/32 (12.5%) |
| Enhanced Treatment as Usual (Student) | 0/35 (0%) | 0/35 (0%) | 2/35 (5.7%) |
| BASIS With TF-CBT (Provider) | — | — | — |
| AC (Attention Control) With TF-CBT (Provider) | — | — | — |
| Enhanced Treatment as Usual (Provider) | — | — | — |
| Event | BASIS With TF-CBT (Student) | Attention Control With TF-CBT (Student) | Enhanced Treatment as Usual (Student) | BASIS With TF-CBT (Provider) | AC (Attention Control) With TF-CBT (Provider) | Enhanced Treatment as Usual (Provider) |
|---|---|---|---|---|---|---|
| Suicidal Ideation/ Self-harmSocial circumstances | 3/34 | 4/32 | 2/35 | — | — | — |
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.
| Age, Categorical(Participants) | BASIS With TF-CBT (Provider) | AC (Attention Control) With TF-CBT (Provider) | Enhanced Treatment as Usual (Provider) | BASIS With TF-CBT (Students) | AC (Attention Control) With TF-CBT (Student) | Enhanced Treatment as Usual (Student) | Total |
|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 34 | 32 | 35 | 101 |
| Between 18 and 65 years | 62 | 64 | 63 | 0 | 0 | 0 | 189 |
| >=65 years | 0 | 1 | 1 | 0 | 0 | 0 | 2 |
| Age, Continuous(Years) | BASIS With TF-CBT (Provider) | AC (Attention Control) With TF-CBT (Provider) | Enhanced Treatment as Usual (Provider) | BASIS With TF-CBT (Students) | AC (Attention Control) With TF-CBT (Student) | Enhanced Treatment as Usual (Student) | Total |
|---|---|---|---|---|---|---|---|
| Mean | — | — | — | 11 ± 2.7 | 12 ± 3.2 | 11.2 ± 2.5 | 11.4 ± 2.8 |
| Sex/Gender, Customized(Participants) | BASIS With TF-CBT (Provider) | AC (Attention Control) With TF-CBT (Provider) | Enhanced Treatment as Usual (Provider) | BASIS With TF-CBT (Students) | AC (Attention Control) With TF-CBT (Student) | Enhanced Treatment as Usual (Student) | Total |
|---|---|---|---|---|---|---|---|
| Female | 58 | 58 | 60 | 16 | 14 | 17 | 223 |
| Male | 2 | 6 | 4 | 18 | 12 | 16 | 58 |
| Transgender | 0 | 0 | 0 | 0 | 2 | 1 | 3 |
| Non-binary | 2 | 0 | 0 | 0 | 2 | 1 | 5 |
| Unknown or not reported | 0 | 1 | 0 | 0 | 2 | 0 | 3 |
| Ethnicity (NIH/OMB)(Participants) | BASIS With TF-CBT (Provider) | AC (Attention Control) With TF-CBT (Provider) | Enhanced Treatment as Usual (Provider) | BASIS With TF-CBT (Students) | AC (Attention Control) With TF-CBT (Student) | Enhanced Treatment as Usual (Student) | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 1 | 10 | 3 | 1 | 20 |
| Not Hispanic or Latino | 59 | 63 | 63 | 24 | 28 | 34 | 271 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | BASIS With TF-CBT (Provider) | AC (Attention Control) With TF-CBT (Provider) | Enhanced Treatment as Usual (Provider) | BASIS With TF-CBT (Students) | AC (Attention Control) With TF-CBT (Student) | Enhanced Treatment as Usual (Student) | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 1 | 0 | 1 | 2 |
| Asian | 1 | 1 | 4 | 1 | 0 | 0 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 2 | 0 | 1 | 4 |
| Black or African American | 2 | 2 | 3 | 0 | 2 | 2 | 11 |
| White | 55 | 55 | 55 | 14 | 17 | 23 | 219 |
| More than one race | 2 | 2 | 1 | 13 | 8 | 5 | 31 |
| Unknown or Not Reported | 2 | 4 | 1 | 3 | 5 | 3 | 18 |
| Region of Enrollment(Participants) | BASIS With TF-CBT (Provider) | AC (Attention Control) With TF-CBT (Provider) | Enhanced Treatment as Usual (Provider) | BASIS With TF-CBT (Students) | AC (Attention Control) With TF-CBT (Student) | Enhanced Treatment as Usual (Student) | Total |
|---|---|---|---|---|---|---|---|
| United States | 62 | 65 | 64 | 34 | 32 | 35 | 292 |
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