Trial Outcomes & Findings for A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy (NCT NCT04451161)
NCT ID: NCT04451161
Last Updated: 2025-09-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
292 participants
Primary outcome timeframe
18 Months- Active phase (timepoint 6 to 9); Sustainment phase (timepoint 10 to 12)
Results posted on
2025-09-12
Participant Flow
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.
Participant milestones
| Measure |
BASIS With TF-CBT (Provider)
Participants who received training for the implementation intervention BASIS and the clinical intervention, trauma-focused CBT.
|
AC (Attention Control) With TF-CBT (Provider)
Participants who received control for the implementation intervention and training for trauma-focused CBT for clinical intervention.
|
Enhanced Treatment as Usual (Provider)
Participants who received control for both implementation and clinical intervention.
|
BASIS With TF-CBT (Students)
Students recruited by providers who received training for the interventions: implementation (BASIS) and clinical (TF-CBT).
|
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.
|
Enhanced Treatment as Usual (Student)
Students recruited by providers who received control for both implementation and clinical intervention.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
62
|
65
|
64
|
34
|
32
|
35
|
|
Overall Study
End of Training Period (Provider)
|
47
|
45
|
54
|
0
|
0
|
0
|
|
Overall Study
End of Active Phase of the Study (Provider)
|
37
|
30
|
48
|
0
|
0
|
0
|
|
Overall Study
3-month Follow up (Student)
|
0
|
0
|
0
|
26
|
24
|
21
|
|
Overall Study
COMPLETED
|
31
|
28
|
42
|
21
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
31
|
37
|
22
|
13
|
13
|
18
|
Reasons for withdrawal
| Measure |
BASIS With TF-CBT (Provider)
Participants who received training for the implementation intervention BASIS and the clinical intervention, trauma-focused CBT.
|
AC (Attention Control) With TF-CBT (Provider)
Participants who received control for the implementation intervention and training for trauma-focused CBT for clinical intervention.
|
Enhanced Treatment as Usual (Provider)
Participants who received control for both implementation and clinical intervention.
|
BASIS With TF-CBT (Students)
Students recruited by providers who received training for the interventions: implementation (BASIS) and clinical (TF-CBT).
|
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.
|
Enhanced Treatment as Usual (Student)
Students recruited by providers who received control for both implementation and clinical intervention.
|
|---|---|---|---|---|---|---|
|
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
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.
Baseline characteristics by cohort
| Measure |
BASIS With TF-CBT (Provider)
n=62 Participants
Participants who received training for the implementation intervention BASIS and the clinical intervention, trauma-focused CBT.
|
AC (Attention Control) With TF-CBT (Provider)
n=65 Participants
Participants who received control for the implementation intervention and training for trauma-focused CBT for clinical intervention.
|
Enhanced Treatment as Usual (Provider)
n=64 Participants
Participants who received control for both implementation and clinical intervention.
|
BASIS With TF-CBT (Students)
n=34 Participants
Students recruited by providers who received training for the interventions: implementation (BASIS) and clinical (TF-CBT).
|
AC (Attention Control) With TF-CBT (Student)
n=32 Participants
Students recruited by providers who received control for the implementation intervention and training for TF-CBT for clinical intervention.
|
Enhanced Treatment as Usual (Student)
n=35 Participants
Students recruited by providers who received control for both implementation and clinical intervention.
|
Total
n=292 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=62 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=64 Participants
|
34 Participants
n=34 Participants
|
32 Participants
n=32 Participants
|
35 Participants
n=35 Participants
|
101 Participants
n=292 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=62 Participants
|
64 Participants
n=65 Participants
|
63 Participants
n=64 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=35 Participants
|
189 Participants
n=292 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=62 Participants
|
1 Participants
n=65 Participants
|
1 Participants
n=64 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=292 Participants
|
|
Age, Continuous
|
—
|
—
|
—
|
11 Years
STANDARD_DEVIATION 2.7 • n=34 Participants • 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.
|
12 Years
STANDARD_DEVIATION 3.2 • n=32 Participants • 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.
|
11.2 Years
STANDARD_DEVIATION 2.5 • n=35 Participants • 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.
|
11.4 Years
STANDARD_DEVIATION 2.8 • n=101 Participants • 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.
|
|
Sex/Gender, Customized
Female
|
58 Participants
n=62 Participants
|
58 Participants
n=65 Participants
|
60 Participants
n=64 Participants
|
16 Participants
n=34 Participants
|
14 Participants
n=32 Participants
|
17 Participants
n=35 Participants
|
223 Participants
n=292 Participants
|
|
Sex/Gender, Customized
Male
|
2 Participants
n=62 Participants
|
6 Participants
n=65 Participants
|
4 Participants
n=64 Participants
|
18 Participants
n=34 Participants
|
12 Participants
n=32 Participants
|
16 Participants
n=35 Participants
|
58 Participants
n=292 Participants
|
|
Sex/Gender, Customized
Transgender
|
0 Participants
n=62 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=32 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=292 Participants
|
|
Sex/Gender, Customized
Non-binary
|
2 Participants
n=62 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=32 Participants
|
1 Participants
n=35 Participants
|
5 Participants
n=292 Participants
|
|
Sex/Gender, Customized
Unknown or not reported
|
0 Participants
n=62 Participants
|
1 Participants
n=65 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=32 Participants
|
0 Participants
n=35 Participants
|
3 Participants
n=292 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=62 Participants
|
2 Participants
n=65 Participants
|
1 Participants
n=64 Participants
|
10 Participants
n=34 Participants
|
3 Participants
n=32 Participants
|
1 Participants
n=35 Participants
|
20 Participants
n=292 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=62 Participants
|
63 Participants
n=65 Participants
|
63 Participants
n=64 Participants
|
24 Participants
n=34 Participants
|
28 Participants
n=32 Participants
|
34 Participants
n=35 Participants
|
271 Participants
n=292 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=62 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=32 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=292 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=62 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=292 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=62 Participants
|
1 Participants
n=65 Participants
|
4 Participants
n=64 Participants
|
1 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=35 Participants
|
7 Participants
n=292 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=62 Participants
|
1 Participants
n=65 Participants
|
0 Participants
n=64 Participants
|
2 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=35 Participants
|
4 Participants
n=292 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=62 Participants
|
2 Participants
n=65 Participants
|
3 Participants
n=64 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=32 Participants
|
2 Participants
n=35 Participants
|
11 Participants
n=292 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=62 Participants
|
55 Participants
n=65 Participants
|
55 Participants
n=64 Participants
|
14 Participants
n=34 Participants
|
17 Participants
n=32 Participants
|
23 Participants
n=35 Participants
|
219 Participants
n=292 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=62 Participants
|
2 Participants
n=65 Participants
|
1 Participants
n=64 Participants
|
13 Participants
n=34 Participants
|
8 Participants
n=32 Participants
|
5 Participants
n=35 Participants
|
31 Participants
n=292 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=62 Participants
|
4 Participants
n=65 Participants
|
1 Participants
n=64 Participants
|
3 Participants
n=34 Participants
|
5 Participants
n=32 Participants
|
3 Participants
n=35 Participants
|
18 Participants
n=292 Participants
|
|
Region of Enrollment
United States
|
62 Participants
n=62 Participants
|
65 Participants
n=65 Participants
|
64 Participants
n=64 Participants
|
34 Participants
n=34 Participants
|
32 Participants
n=32 Participants
|
35 Participants
n=35 Participants
|
292 Participants
n=292 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
BASIS With TF-CBT (Provider)
n=47 Participants
Participants who received training for the implementation intervention BASIS and the clinical intervention, trauma-focused CBT.
|
AC (Attention Control) With TF-CBT (Provider)
n=45 Participants
Participants who received control for the implementation intervention and training for trauma-focused CBT for clinical intervention.
|
Enhanced Treatment as Usual (Provider)
n=54 Participants
Participants who received control for both implementation and clinical intervention.
|
|---|---|---|---|
|
TF-CBT Adoption and Penetration
Administered CPSS-V with at least one student.
|
33 Participants
|
26 Participants
|
33 Participants
|
|
TF-CBT Adoption and Penetration
Started TF-CBT with at least one student.
|
31 Participants
|
26 Participants
|
21 Participants
|
|
TF-CBT Adoption and Penetration
Completed TF-CBT with at least one student.
|
11 Participants
|
12 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
BASIS With TF-CBT (Provider)
n=34 Participants
Participants who received training for the implementation intervention BASIS and the clinical intervention, trauma-focused CBT.
|
AC (Attention Control) With TF-CBT (Provider)
n=32 Participants
Participants who received control for the implementation intervention and training for trauma-focused CBT for clinical intervention.
|
Enhanced Treatment as Usual (Provider)
n=35 Participants
Participants who received control for both implementation and clinical intervention.
|
|---|---|---|---|
|
Child PTSD Symptom Scale for DSM-V
Baseline (T1)
|
34.7 Score on a scale
Standard Deviation 15.9
|
39.3 Score on a scale
Standard Deviation 18.7
|
37.1 Score on a scale
Standard Deviation 16.1
|
|
Child PTSD Symptom Scale for DSM-V
3-month follow up (T2)
|
28.3 Score on a scale
Standard Deviation 16.2
|
34.4 Score on a scale
Standard Deviation 16.2
|
28.1 Score on a scale
Standard Deviation 17.4
|
|
Child PTSD Symptom Scale for DSM-V
6-month follow up (T3)
|
26.1 Score on a scale
Standard Deviation 17.7
|
32.2 Score on a scale
Standard Deviation 18.8
|
19.4 Score on a scale
Standard Deviation 16.3
|
PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
BASIS With TF-CBT (Provider)
n=34 Participants
Participants who received training for the implementation intervention BASIS and the clinical intervention, trauma-focused CBT.
|
AC (Attention Control) With TF-CBT (Provider)
n=32 Participants
Participants who received control for the implementation intervention and training for trauma-focused CBT for clinical intervention.
|
Enhanced Treatment as Usual (Provider)
n=35 Participants
Participants who received control for both implementation and clinical intervention.
|
|---|---|---|---|
|
Mood and Feelings Questionnaire - Short
Baseline (T1)
|
10.3 score on a scale
Standard Deviation 7.7
|
11.7 score on a scale
Standard Deviation 7.1
|
10.7 score on a scale
Standard Deviation 5.9
|
|
Mood and Feelings Questionnaire - Short
3-month follow up (T2)
|
7.7 score on a scale
Standard Deviation 4.8
|
12.1 score on a scale
Standard Deviation 6.3
|
7.2 score on a scale
Standard Deviation 4.4
|
|
Mood and Feelings Questionnaire - Short
6-month follow-up (T3)
|
6.8 score on a scale
Standard Deviation 6.3
|
10 score on a scale
Standard Deviation 7.3
|
4.9 score on a scale
Standard Deviation 4.3
|
Adverse Events
BASIS With TF-CBT (Student)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Attention Control With TF-CBT (Student)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Enhanced Treatment as Usual (Student)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BASIS With TF-CBT (Provider)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AC (Attention Control) With TF-CBT (Provider)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Treatment as Usual (Provider)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BASIS With TF-CBT (Student)
n=34 participants at risk
Students recruited by providers who received training for the interventions: implementation (BASIS) and clinical (TF-CBT).
|
Attention Control With TF-CBT (Student)
n=32 participants at risk
Students recruited by providers who received control for the implementation intervention and training for TF-CBT for clinical intervention.
|
Enhanced Treatment as Usual (Student)
n=35 participants at risk
Students recruited by providers who received control for both implementation and clinical intervention.
|
BASIS With TF-CBT (Provider)
Participants who received training for the implementation intervention BASIS and the clinical intervention, trauma-focused CBT.
|
AC (Attention Control) With TF-CBT (Provider)
Participants who received control for the implementation intervention and training for trauma-focused CBT for clinical intervention.
|
Enhanced Treatment as Usual (Provider)
Participants who received control for both implementation and clinical intervention.
|
|---|---|---|---|---|---|---|
|
Social circumstances
Suicidal Ideation/ Self-harm
|
8.8%
3/34 • Number of events 3 • 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.
|
12.5%
4/32 • Number of events 4 • 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.
|
5.7%
2/35 • Number of events 2 • 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.
|
—
0/0 • 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.
|
—
0/0 • 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.
|
—
0/0 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place