Evidence-Based PracticesNCT04451161

A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy

A study testing Beliefs and Attitudes for Successful Implementation in Schools (BASIS), Trauma-Focused Cognitive-Behavioral Therapy and Treatment as Usual in people with Evidence-Based Practices and CBT, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 7 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Evidence-Based Practices, CBT, School Health Services
What is being tested?: Beliefs and Attitudes for Successful Implementation in Schools (BASIS), Trauma-Focused Cognitive-Behavioral Therapy and Treatment as Usual
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 292 participants
Where: 1 siteUnited States
Study dates: 27 Aug 2020to 30 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 85 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington
Seattle, Washington, 98115

Other trials in United States

About this study

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).

Conditions: Evidence-Based Practices, CBT, School Health Services, Trauma, Psychological
Being tested: Beliefs and Attitudes for Successful Implementation in Schools (BASIS), Trauma-Focused Cognitive-Behavioral Therapy, Treatment as Usual, Attention Control
Medical subject headings: Psychological Trauma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Beliefs and Attitudes for Successful Implementation in Schools (BASIS)Behavioural
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.
Trauma-Focused Cognitive-Behavioral TherapyBehavioural
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.
Treatment as UsualBehavioural
Scaffolded intervention as usual. Includes: initial assessment of trauma symptoms, psychoeducation, follow-up planning and support.
Attention ControlBehavioural
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

Study groups in NCT04451161
Study group	Role	What they receive
BASIS with TF-CBT	Other	Implementation intervention: experimental arm (Beliefs and Attitudes for Successful Implementation in Schools) Clinical Intervention: experimental arm (Trauma-Focused CBT) Receives: Behavioral: Beliefs and Attitudes for Successful Implementation in Schools (BASIS); Behavioral: Trauma-Focused Cognitive-Behavioral Therapy
Attention Control (AC) with TF-CBT	Other	Implementation intervention: control arm Clinical Intervention: experimental arm (Trauma-Focused CBT) Receives: Behavioral: Trauma-Focused Cognitive-Behavioral Therapy; Behavioral: Attention Control
Enhanced Treatment as Usual	Other	Implementation intervention: non-applicable Clinical Intervention: control arm (Enhanced TAU) Receives: Behavioral: Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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).
Measured: 6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Aug 202030 Jun 2024

First posted30 Jun 2020
Study start27 Aug 2020
Primary completion1 Jun 2024
Study completion30 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Evidence-Based PracticesStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Care provider
Enrolment: 292 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04451161
Sponsor's protocol ID: STUDY00008401
Other IDs: 1R01MH119148-01A1
Status last verified: Sep 2025
First submitted: 23 Jun 2020
Last updated: 12 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 33413511

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy
ClinicalTrials.gov ID: NCT04451161
Acronym / sponsor ID: STUDY00008401
Conditions: Evidence-Based Practices, CBT, School Health Services, Trauma, Psychological
Study type: Interventional
Recruitment status: Completed
Enrolment: 292 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH), University of Minnesota
Study start: 27 Aug 2020 (actual)
Primary completion: 1 Jun 2024 (actual)
Study completion: 30 Jun 2024 (actual)
First posted: 30 Jun 2020 (actual)
Results: Posted 15 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 3

Arm	Type	Receives
BASIS with TF-CBT	Other	Behavioral: Beliefs and Attitudes for Successful Implementation in Schools (BASIS), Behavioral: Trauma-Focused Cognitive-Behavioral TherapyImplementation intervention: experimental arm (Beliefs and Attitudes for Successful Implementation in Schools) Clinical Intervention: experimental arm (Trauma-Focused CBT)
Attention Control (AC) with TF-CBT	Other	Behavioral: Trauma-Focused Cognitive-Behavioral Therapy, Behavioral: Attention ControlImplementation intervention: control arm Clinical Intervention: experimental arm (Trauma-Focused CBT)
Enhanced Treatment as Usual	Other	Behavioral: Treatment as UsualImplementation intervention: non-applicable Clinical Intervention: control arm (Enhanced TAU)

Who may qualify

Ages: 7 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Beliefs 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.	Behavioural	BASIS with TF-CBT
Trauma-Focused Cognitive-Behavioral TherapyTF-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.	Behavioural	Attention Control (AC) with TF-CBT, BASIS with TF-CBT
Treatment as UsualScaffolded intervention as usual. Includes: initial assessment of trauma symptoms, psychoeducation, follow-up planning and support.	Behavioural	Enhanced Treatment as Usual
Attention ControlDidactic 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	Behavioural	Attention Control (AC) with TF-CBT

Primary outcome

TF-CBT Adoption and Penetration
Time frame: 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
Time frame: 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
Time frame: 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).

Results and safety

Results posted to the registry on 15 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BASIS With TF-CBT (Provider)	62	31
AC (Attention Control) With TF-CBT (Provider)	65	28
Enhanced Treatment as Usual (Provider)	64	42
BASIS With TF-CBT (Students)	34	21
AC (Attention Control) With TF-CBT (Student)	32	19
Enhanced Treatment as Usual (Student)	35	17

Primary outcome: TF-CBT Adoption and Penetration

Time frame: 18 Months- Active phase (timepoint 6 to 9); Sustainment phase (timepoint 10 to 12). Count of participants. Unit: Participants

Measure	BASIS With TF-CBT (Provider) n = 47	AC (Attention Control) With TF-CBT (Provider) n = 45	Enhanced Treatment as Usual (Provider) n = 54
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

BASIS With TF-CBT (Provider) vs AC (Attention Control) With TF-CBT (Provider): p = 0.591, Chi-squared
BASIS With TF-CBT (Provider) vs AC (Attention Control) With TF-CBT (Provider): p = 0.032, Chi-squared
BASIS With TF-CBT (Provider) vs AC (Attention Control) With TF-CBT (Provider): p = 0.054, Chi-squared

Population analysed: 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.

Primary outcome: Child PTSD Symptom Scale for DSM-V

Time frame: 6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3). Mean (Standard Deviation). Unit: Score on a scale

Measure	BASIS With TF-CBT (Student) n = 34	Attention Control With TF-CBT (Student) n = 32	Enhanced Treatment as Usual (Student) n = 35
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)

BASIS With TF-CBT (Student) vs Enhanced Treatment as Usual (Student): Slope: 3.425 (95% CI -2.064 to 8.915), p = 0.22, Mixed Models Analysis
Attention Control With TF-CBT (Student) vs Enhanced Treatment as Usual (Student): Slope: 4.97 (95% CI -.502 to 10.443), p = 0.075, Mixed Models Analysis

Population analysed: All the participants (students) who received trauma-informed intervention- TF-CBT or Enhanced treatment as usual.

Primary outcome: Mood and Feelings Questionnaire - Short

Time frame: 6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3). Mean (Standard Deviation). Unit: score on a scale

Measure	BASIS With TF-CBT (Student) n = 34	Attention Control With TF-CBT (Student) n = 32	Enhanced Treatment as Usual (Student) n = 35
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)

BASIS With TF-CBT (Student) vs Enhanced Treatment as Usual (Student): Slope: 1.024 (95% CI -.855 to 2.904), p = 0.284, Mixed Models Analysis
Attention Control With TF-CBT (Student) vs Enhanced Treatment as Usual (Student): Slope: 1.908 (95% CI .03 to 3.786), p = .046, Mixed Models Analysis

Population analysed: All the participants (students) who received trauma-informed intervention- TF-CBT or Enhanced Treatment as Usual.

Adverse events

Time frame: 6 months- Baseline (T1), 3-month follow up (T2), 6-month follow up (T3). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BASIS With TF-CBT (Student)	0 of 34 (0%)	3 of 34 (8.8%)	0 of 34
Attention Control With TF-CBT (Student)	0 of 32 (0%)	4 of 32 (12.5%)	0 of 32
Enhanced Treatment as Usual (Student)	0 of 35 (0%)	2 of 35 (5.7%)	0 of 35
BASIS With TF-CBT (Provider)	0 of 0	0 of 0	0
AC (Attention Control) With TF-CBT (Provider)	0 of 0	0 of 0	0
Enhanced Treatment as Usual (Provider)	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33413511Lyon 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aaron Lyon, PhD principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TF-CBT Adoption and Penetration (time frame: 18 Months- Active phase (timepoint 6 to 9); Sustainment phase (timepoint 10 to 12)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04451161, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.