CompletedNot Applicable

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

United States292 participantsStarted 2020-08-27

Plain-language 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).

Who can participate

Age range

7 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

TF-CBT Adoption and Penetration

Timeframe: 18 Months- Active phase (timepoint 6 to 9); Sustainment phase (timepoint 10 to 12)

Child PTSD Symptom Scale for DSM-V

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

Mood and Feelings Questionnaire - Short

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

Trial details

NCT IDNCT04451161

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-01

Results submitted2025-05-29

View on ClinicalTrials.gov More Evidence-Based Practices trials

Plain-language summary

Who can participate

Age range

7 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

TF-CBT Adoption and Penetration

Timeframe: 18 Months- Active phase (timepoint 6 to 9); Sustainment phase (timepoint 10 to 12)

Child PTSD Symptom Scale for DSM-V

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

Mood and Feelings Questionnaire - Short

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