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Completed

NCT Number: NCT04451161

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

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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Key information

Conditions

Evidence-based Practices CBT Mental Disorders Psychological Trauma School Health Services Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Psychological

Age range

7 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Beliefs and Attitudes for Successful Implementation in Schools (BASIS)

Behavioral

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 Therapy

Behavioral

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 Usual

Behavioral

Scaffolded intervention as usual. Includes: initial assessment of trauma symptoms, psychoeducation, follow-up planning and support.

Attention Control

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of Minnesota

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 30, 2020
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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