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NCT04451161 · ClinicalTrials.gov registry record · NA

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

A NA study of Trauma, Psychological and CBT, sponsored by University of Washington.

Completed
Registry status
NA
Development phase
292
Enrollment target
1
Study location

NCT04451161 is a NA study of Trauma, Psychological and CBT that has completed, run by University of Washington. The registered enrollment target is 292 participants, above the 103-participant average among 14 other Trauma, Psychological trials with a reported enrollment target (183% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT04451161, a NA study of Trauma, Psychological and CBT, has completed, sponsored by University of Washington.

COMPLETED
Registry status
NA
Development phase
292 participants
Enrollment target
1
Study location

Study 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

  • BEHAVIORAL Attention Control
  • BEHAVIORAL Treatment as Usual
  • BEHAVIORAL Beliefs and Attitudes for Successful Implementation in Schools (BASIS)
  • BEHAVIORAL Trauma-Focused Cognitive-Behavioral Therapy

Study Locations (1)

Washington

  • University of Washington - Seattle

Trial Details

FieldValue
Enrollment Target 292 participants
Start Date 2020-08-27
Est. Completion 2024-06-30
Phase NA

Sponsor

University of Washington

1,048 total trials

What the Registry Record Tells You About NCT04451161

The ClinicalTrials.gov registry entry for NCT04451161 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 292 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 103-participant average among 14 other Trauma, Psychological trials with a reported enrollment target (183% higher). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Trauma, Psychological appearing as the primary indexed condition, and to 4 interventions - of which Attention Control is the first listed.

NCT04451161 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT04451161 about?

NCT04451161 is a clinical study titled "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,...

What is the current status of trial NCT04451161?

This trial is currently completed. It is a NA study. The enrollment target is 292 participants. The study started on 2020-08-27. Estimated completion is 2024-06-30.

What conditions does trial NCT04451161 study?

This clinical trial studies the following conditions: Trauma, Psychological, CBT, Evidence-Based Practices, School Health Services.

What interventions are being tested in trial NCT04451161?

The interventions under investigation include: Attention Control (BEHAVIORAL), Treatment as Usual (BEHAVIORAL), Beliefs and Attitudes for Successful Implementation in Schools (BASIS) (BEHAVIORAL), Trauma-Focused Cognitive-Behavioral Therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT04451161?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04451161 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.