CBT, Evidence-Based Practices, School Health Services, Trauma, Psychological
Conditions
Brief summary
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).
Interventions
BEHAVIORALBeliefs and Attitudes for Successful Implementation in Schools (BASIS)
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.
BEHAVIORALTrauma-Focused Cognitive-Behavioral Therapy
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.
BEHAVIORALTreatment as Usual
Scaffolded intervention as usual. Includes: initial assessment of trauma symptoms, psychoeducation, follow-up planning and support.
BEHAVIORALAttention Control
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
Sponsors
National Institute of Mental Health (NIMH)
University of Minnesota
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Caregiver)
Masking description
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).
Eligibility
Sex/Gender
ALL
Age
7 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TF-CBT Adoption and Penetration | 18 Months- Active phase (timepoint 6 to 9); Sustainment phase (timepoint 10 to 12) | 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. |
| Child PTSD Symptom Scale for DSM-V | 6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3) | 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. |
| Mood and Feelings Questionnaire - Short | 6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3) | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| BASIS With TF-CBT (Provider) Participants who received training for the implementation intervention BASIS and the clinical intervention, trauma-focused CBT. | 62 |
| AC (Attention Control) With TF-CBT (Provider) Participants who received control for the implementation intervention and training for trauma-focused CBT for clinical intervention. | 65 |
| Enhanced Treatment as Usual (Provider) Participants who received control for both implementation and clinical intervention. | 64 |
| BASIS With TF-CBT (Students) Students recruited by providers who received training for the interventions: implementation (BASIS) and clinical (TF-CBT). | 34 |
| 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. | 32 |
| Enhanced Treatment as Usual (Student) Students recruited by providers who received control for both implementation and clinical intervention. | 35 |
| Total | 292 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 28 | 37 | 22 | 13 | 11 | 14 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 0 | 0 | 2 | 4 |
Baseline characteristics
| Characteristic | Total | AC (Attention Control) With TF-CBT (Provider) | Enhanced Treatment as Usual (Provider) | BASIS With TF-CBT (Students) | BASIS With TF-CBT (Provider) | AC (Attention Control) With TF-CBT (Student) | Enhanced Treatment as Usual (Student) |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 101 Participants | 0 Participants | 0 Participants | 34 Participants | 0 Participants | 32 Participants | 35 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 189 Participants | 64 Participants | 63 Participants | 0 Participants | 62 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 11.4 Years STANDARD_DEVIATION 2.8 | — | — | 11 Years STANDARD_DEVIATION 2.7 | — | 12 Years STANDARD_DEVIATION 3.2 | 11.2 Years STANDARD_DEVIATION 2.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 2 Participants | 1 Participants | 10 Participants | 3 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 271 Participants | 63 Participants | 63 Participants | 24 Participants | 59 Participants | 28 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 1 Participants | 4 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 2 Participants | 3 Participants | 0 Participants | 2 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 31 Participants | 2 Participants | 1 Participants | 13 Participants | 2 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 18 Participants | 4 Participants | 1 Participants | 3 Participants | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) White | 219 Participants | 55 Participants | 55 Participants | 14 Participants | 55 Participants | 17 Participants | 23 Participants |
| Region of Enrollment United States | 292 Participants | 65 Participants | 64 Participants | 34 Participants | 62 Participants | 32 Participants | 35 Participants |
| Sex/Gender, Customized Female | 223 Participants | 58 Participants | 60 Participants | 16 Participants | 58 Participants | 14 Participants | 17 Participants |
| Sex/Gender, Customized Male | 58 Participants | 6 Participants | 4 Participants | 18 Participants | 2 Participants | 12 Participants | 16 Participants |
| Sex/Gender, Customized Non-binary | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants |
| Sex/Gender, Customized Transgender | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants |
| Sex/Gender, Customized Unknown or not reported | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 32 | 0 / 35 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 3 / 34 | 4 / 32 | 2 / 35 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 34 | 0 / 32 | 0 / 35 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3)
Population: All the participants (students) who received trauma-informed intervention- TF-CBT or Enhanced treatment as usual.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BASIS With TF-CBT (Provider) | Child PTSD Symptom Scale for DSM-V | 3-month follow up (T2) | 28.3 Score on a scale | Standard Deviation 16.2 |
| BASIS With TF-CBT (Provider) | Child PTSD Symptom Scale for DSM-V | Baseline (T1) | 34.7 Score on a scale | Standard Deviation 15.9 |
| BASIS With TF-CBT (Provider) | Child PTSD Symptom Scale for DSM-V | 6-month follow up (T3) | 26.1 Score on a scale | Standard Deviation 17.7 |
| AC (Attention Control) With TF-CBT (Provider) | Child PTSD Symptom Scale for DSM-V | 3-month follow up (T2) | 34.4 Score on a scale | Standard Deviation 16.2 |
| AC (Attention Control) With TF-CBT (Provider) | Child PTSD Symptom Scale for DSM-V | Baseline (T1) | 39.3 Score on a scale | Standard Deviation 18.7 |
| AC (Attention Control) With TF-CBT (Provider) | Child PTSD Symptom Scale for DSM-V | 6-month follow up (T3) | 32.2 Score on a scale | Standard Deviation 18.8 |
| Enhanced Treatment as Usual (Provider) | Child PTSD Symptom Scale for DSM-V | Baseline (T1) | 37.1 Score on a scale | Standard Deviation 16.1 |
| Enhanced Treatment as Usual (Provider) | Child PTSD Symptom Scale for DSM-V | 6-month follow up (T3) | 19.4 Score on a scale | Standard Deviation 16.3 |
| Enhanced Treatment as Usual (Provider) | Child PTSD Symptom Scale for DSM-V | 3-month follow up (T2) | 28.1 Score on a scale | Standard Deviation 17.4 |
Comparison: We compared the BASIS group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT reduced trauma-related PTSD symptoms over time, as measured by CPSS-V scores (higher scores indicate greater symptom severity).p-value: 0.2295% CI: [-2.064, 8.915]Mixed Models Analysis
Comparison: We compared the AC group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT reduced trauma-related PTSD symptoms over time, as measured by CPSS-V scores (higher scores indicate greater symptom severity).p-value: 0.07595% CI: [-0.502, 10.443]Mixed Models Analysis
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).
Time frame: 6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3)
Population: All the participants (students) who received trauma-informed intervention- TF-CBT or Enhanced Treatment as Usual.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BASIS With TF-CBT (Provider) | Mood and Feelings Questionnaire - Short | 6-month follow-up (T3) | 6.8 score on a scale | Standard Deviation 6.3 |
| BASIS With TF-CBT (Provider) | Mood and Feelings Questionnaire - Short | 3-month follow up (T2) | 7.7 score on a scale | Standard Deviation 4.8 |
| BASIS With TF-CBT (Provider) | Mood and Feelings Questionnaire - Short | Baseline (T1) | 10.3 score on a scale | Standard Deviation 7.7 |
| AC (Attention Control) With TF-CBT (Provider) | Mood and Feelings Questionnaire - Short | 6-month follow-up (T3) | 10 score on a scale | Standard Deviation 7.3 |
| AC (Attention Control) With TF-CBT (Provider) | Mood and Feelings Questionnaire - Short | Baseline (T1) | 11.7 score on a scale | Standard Deviation 7.1 |
| AC (Attention Control) With TF-CBT (Provider) | Mood and Feelings Questionnaire - Short | 3-month follow up (T2) | 12.1 score on a scale | Standard Deviation 6.3 |
| Enhanced Treatment as Usual (Provider) | Mood and Feelings Questionnaire - Short | 3-month follow up (T2) | 7.2 score on a scale | Standard Deviation 4.4 |
| Enhanced Treatment as Usual (Provider) | Mood and Feelings Questionnaire - Short | Baseline (T1) | 10.7 score on a scale | Standard Deviation 5.9 |
| Enhanced Treatment as Usual (Provider) | Mood and Feelings Questionnaire - Short | 6-month follow-up (T3) | 4.9 score on a scale | Standard Deviation 4.3 |
Comparison: We compared the BASIS group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT decreased children's negative moods and feelings due to their trauma (higher score indicates more negative mood and feelings).p-value: 0.28495% CI: [-0.855, 2.904]Mixed Models Analysis
Comparison: We compared the AC group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT decreased children's negative moods and feelings due to their trauma (higher score indicates more negative mood and feelings).p-value: 0.04695% CI: [0.03, 3.786]Mixed Models Analysis
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.
Time frame: 18 Months- Active phase (timepoint 6 to 9); Sustainment phase (timepoint 10 to 12)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BASIS With TF-CBT (Provider) | TF-CBT Adoption and Penetration | Started TF-CBT with at least one student. | 31 Participants |
| BASIS With TF-CBT (Provider) | TF-CBT Adoption and Penetration | Administered CPSS-V with at least one student. | 33 Participants |
| BASIS With TF-CBT (Provider) | TF-CBT Adoption and Penetration | Completed TF-CBT with at least one student. | 11 Participants |
| AC (Attention Control) With TF-CBT (Provider) | TF-CBT Adoption and Penetration | Started TF-CBT with at least one student. | 26 Participants |
| AC (Attention Control) With TF-CBT (Provider) | TF-CBT Adoption and Penetration | Administered CPSS-V with at least one student. | 26 Participants |
| AC (Attention Control) With TF-CBT (Provider) | TF-CBT Adoption and Penetration | Completed TF-CBT with at least one student. | 12 Participants |
| Enhanced Treatment as Usual (Provider) | TF-CBT Adoption and Penetration | Administered CPSS-V with at least one student. | 33 Participants |
| Enhanced Treatment as Usual (Provider) | TF-CBT Adoption and Penetration | Completed TF-CBT with at least one student. | 19 Participants |
| Enhanced Treatment as Usual (Provider) | TF-CBT Adoption and Penetration | Started TF-CBT with at least one student. | 21 Participants |
Comparison: 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 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.p-value: 0.591Chi-squared
Comparison: 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.p-value: 0.032Chi-squared
Comparison: 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.p-value: 0.054Chi-squared
Comparison: 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.p-value: 0.98Chi-squared
Comparison: 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.p-value: 0.068Chi-squared
Comparison: 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.p-value: 0.165Chi-squared
Comparison: 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.p-value: 0.191Chi-squared
Comparison: 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.p-value: 0.86Chi-squared